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 As a DATA SCIENTIST within our Personalized HealthCare (PHC) function you will work with meaningful data to generate impactful evidence and insights on our molecules/ medicines and patients, that support R&D, advance scientific and medical knowledge, and enable personalized patient care and access.

You will collaborate with peers within the function and across the organization to develop evidence generation strategies, identify evidence gaps and data sources, design and execute studies, and implement analyses to address molecule and disease area questions. The data will be varied in type -- patient-level clinical data,  supplemented with deep patient data such as omics (e.g. genomics, proteomic), imaging, digital health, etc.  Source data will be diverse -- real-world data, including patient registries, electronic medical records, claims, biobanks, and clinical trials. The evidence and insights will be used to inform the research and development of our molecules, and support healthcare decisions by patients, physicians, health authorities, payers, and policy-makers. You will also contribute to functional, cross-functional, enterprise-wide or external  initiatives that shape our business and healthcare environments. This will require a good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical data science expertise. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to transform the way we use data and analytics to develop and deliver medicines for our patients.

RESPONSIBILITIES

• IDENTIFY EVIDENCE NEEDS & RECOMMEND DATA SOLUTIONS: Ask the right scientific questions, understand the evidence needs for research and development, regulatory and market access, and ideate and make recommendations on fit-for-purpose data and analytics solutions.
• DEVELOP DATA STRATEGY & GAIN ACCESS TO DATA: Develop strategic plans to access fit-for-purpose data sources to support evidence generation, and gain access to data through collaboration or data generation.
• DIVE INTO DATA: Develop a comprehensive and deep understanding of the data we work with and foster learning with colleagues using analytical tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately.
• BE AN EXPERT IN APPLYING METHODS: Stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches.
• PRODUCE HIGH QUALITY ANALYSES: Apply rigor in study design and analytical  methods; plan for data processing; design a fit-for-purpose analysis plan,  assess effective ways of presenting and delivering the results to maximize impact and interpretability; implement and/or oversee the study, including its reporting; ensure compliance with applicable  pharma industry regulations and standards.
• INTERPRET AND SHARE RESULTS: Communicate findings to internal stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities; publish results; participate in external meetings and forums to present your insights (e.g. congress/conference).
• COLLABORATE & SHAPE: Collaborate and contribute to functional, cross-functional, enterprise-wide or external data science communities, networks, collaboratives, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, processes, etc. to enable broader and more effective use of data and analytics to support business. 

This position is part of Genentech’s EHS function. EHS plays an essential role in protecting Genentech’s right to operate and serving as a steward for the Genentech culture embracing prevention and problem solving to reduce risks and protect our people, environment and pipeline on our SSF campus and network of places, including field based employees.  At Genentech, compliance is a shared responsibility with the business.

This position will work closely with EHS program managers, business partners and clients to assist in the development, implementation and maintenance of a variety of EHS programs, projects and initiatives.  These efforts are intended to balance protection against risk with the need to deliver with speed and add value to the business.

Under general oversight and direction this individual will use their independent analysis skills and judgment to deliver in support of EHS activities which may include:

• Inspections and assessments
• Program audits
• Training development and delivery
• Metrics tracking and reporting
• Assisting others to conduct incident investigations
• Developing corrective/preventive action plans with clients

The ideal candidate will have experience in the practical application of multi-disciplinary EHS programs, work with a high sense of urgency, possess excellent communication and teamwork skills and be resourceful and eager to develop.

Job Duties/Responsibilities:

• Executes tasks in support of EHS programs with general direction and guidance from the EHS AD or EHS supervisor, program managers and business partners.  The work may include: inspections, assessments, program audits, incident investigations, data reporting, monitoring and report submissions.
• Supports daily EHS client needs alongside program managers and business partners, including: responding to inquiries from clients, participating in meetings and assisting with incident investigations and corrective & preventive actions (CAPAs).
• Conducts EHS program compliance assurance audits, including data collection, employee interviews and area walkthroughs.
• Supports EHS program managers and business partners in their effort to proactively identify opportunities and solutions to improve EHS programs.
• Assists with the development and delivery of EHS training.  Works with EHS program managers to improve training materials and effectiveness.
• Participates in some regulatory inspections and internal/external audits.
• Maintains applicable safety and environmental permits and permit conditions.

• Supports engagement and communications with clients and EHS staff regarding EHS activities and performance.

• Responds to client inquiries and requests with a high sense of urgency.
• Assists with project prioritization and promotion of a proactive EHS culture, leveraging knowledge built of EHS business processes.

• Participates and supports business process improvement activity as a team member, contributing to a proactive EHS culture. Identifies opportunities from challenges. Champions EHS with key stakeholders.

• Serves as needed as a Safety Officer during disaster/emergency response and recovery efforts. May also be required to serve as EHS Advisor (technical expert) for the emergency response team during company-related emergencies.

Competencies Identified for Success:

• Experience with practical application of safety, environmental (i.e, OSHA, EPA, DOT, NIOSH, etc.) and other regulatory requirements applicable to GMP and non-GMP environments.
• Works well in a fast-paced environment and makes sound EHS decisions with some oversight and direction.
• Effective communicator in both verbal and written formats; comfortable with leading meetings, delivering training and developing written communications.
• Responsive to client and other stakeholder inquiries and requests with a high sense of urgency.
• Proactive in their approach to finding opportunities and solutions for EHS program implementation and improvement.
• Demonstrates the ability to support multiple program managers and business partners simultaneously, while staying organized and focused.
• Highly effective team player and collaborator. Strong comfort working in a matrix environment and leveraging expertise across functions.  This may include participating in agile teams focused on creating value for the business.

Qualifications: Education, Experience, Knowledge and Skills

(Minimum requirements)

• Education:  BA or BS in occupational safety, environmental/health sciences or  related field.
• Minimum of 5-7 years of relevant experience, preferably in pharmaceutical, biotech, medical device or high tech industries.
• Knowledgeable in applicable Cal OSHA, EPA, DOT regulations as well as ANSI and NFPA standards.
• Proficient with Microsoft Word, Excel, and Powerpoint as well as the Google suite of programs (gMail, gCal, docs, sheets, slides, etc.).
• This position is not eligible for relocation.

The Department of Pathology/Section on Comparative Medicine at Wake Forest School of Medicine (WFSM) in collaboration with Roche, is actively seeking a highly motivated Postdoctoral Fellow in the area of cancer immunotherapy. This mentored position will provide unique experience in the field of comparative oncology which aims at comparing tumors from preclinical models and humans.

Wake Forest is home to the top-ranking National Cancer Institute-sponsored Comprehensive Cancer Center in North Carolina (USA), with an abundance of collaborative opportunities and research infrastructure. The Medical Center is the major employer in Winston-Salem, an affordable community of 240,000 in the Piedmont region of North Carolina.

When you join our team you will hold several of these primary responsibilities:

• Biomarker characterization and treatment of innovative animal models with naturally occurring cancers
• Use state of the art functional imaging, flow cytometry, pathology, genomics and bioinformatics tools available at WFSM
• Contribute to the understanding of the anti-tumor immune response and translate the acquired learning in clinical setting

The applicant will receive training in a highly collaborative, multidisciplinary academic-industry partnership environment.

This full-time position is renewable annually, with an expected 2-3 years duration. Salary will be NIH scale, commensurate with experience. WFSM provides health insurance. We seek candidates who embrace and reflect diversity. Wake Forest School of Medicine is an affirmative action/equal opportunity employer.

Your Profile:

We are looking for a highly motivated and energetic person who recently completed her/his PhD, DVM, MD or other comparable professional training and has a strong interest in translational research. If you bring as well the following you are the ideal candidate for this position:

• A strong track record based on 1st author publications
• Strong experience in preclinical or translational studies of immuno-oncology agents, anti-tumor vaccines, or cellular therapies of cancer
• Bench-top skills, research design, and scientific writing in tumor immunology and comparative oncology
• Fluency in English written and spoken

Interested candidates should submit a CV, a Research Statement indicating your scientific interests and accomplishments, 1-3 relevant original first author publications, and the names and email addresses of three professional references. Interested candidates should apply online. The position is based in Winston-Salem, North Carolina (USA).

Application review will begin immediately and continue until the position is filled.

**RELOCATION IS NOT DESIGNATED FOR THIS POSITION**

Position Purpose: 

• Provides operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs) 

• Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. 

Main Responsibilities and Accountabilities: 

• Provides direction and leadership to one or more global Study Management Teams (SMTs) 

• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management 
• Builds and maintains effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables 
• Creates team culture and promotes team spirit 
• Develops and maintains effective working relationships with Study Management Team (SMT) members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams 
• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members 
• Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work 
• Responsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functions 
• Responsible for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of work 

• Contributes to the development and management of the study timelines, budget, risk and quality plans 

• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Global Studies Leader (GSL) 
• Develops and manages clinical study budgets (including HQ budget). Communicates variances in the budget and action plan for resolution to the GSL 
• Establishes study milestones and ensures accurate tracking and reporting of study metrics such as initial recruitment projections 
• Provides operational input into the development of protocol feasibility questionnaires 

• Provides clinical operations expertise to ensure operational feasibility and delivery 

• Leads the development and finalization of site feasibility questionnaires 
• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and Operational Program Leader (OPL) 
• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes 
• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers 

• Oversees forecasting of clinical/non-clinical supplies 

• Designs drug assumption and supply chain process in partnership with Drug Supplies, affiliates and GSL 
• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study 

• Delivers the operational elements of the study plan 

• Chairs operations team meeting and organizes investigator meetings, monitor training, CRO kick-off meetings 
• Ensures that reporting process of SUSARs is established and maintained for the duration of the study 
• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with key stakeholders 
• Primary contact with affiliates to maintain oversight of performance, issues, their resolution and coordinates any corrective action 
• Actively partner with Data Management and Clinical Science to oversee eCRF completion and data quality issues 
• Ensures the completion and finalization of any corrective and preventative action plans resulting from site audits, in conjunction with CCO, etc., as necessary 
• Oversees the maintenance of drug supplies and resolution of issues with input from the Drug Supplies 
• Coordinates responses to study questions or issues from Health Authorities 
• Provides operational input into the development and tracking of SMT goals 

• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work 

• Performs ongoing vendor management (e.g., CROs, Central Labs, IxRS, etc.), including negotiation of scope of work, budgets, performance management, and issue resolution 
• Develops and supports appropriate site and CRO/vendor audit and quality plans 

• Identifies areas of best practice and process improvements 

• Participates in Product Development Global Operations initiatives and programs as assigned 
• Maintains oversight and ensures consistency of the operational aspects across studies within a project 

• Ensures study adherence to ICH/GCP and SOPs 

Qualifications

Life sciences degree or nursing equivalent. 

Skills & Knowledge: 

• Experience 

• Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock. 
• Experience of project managing operational aspects of a clinical study including development and management of timelines and budgets. 
• Good knowledge of ICH GCP 
• Proven ability to successfully achieve results within a multi-cultural and geographically diverse team. 
• Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments. 
• Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization. 
• Strong attention to detail 
• Proficient computer skills 

• Competencies 

• Technical and Business Expertise 
• Teamwork and Collaboration 
• Communication 
• Achieving Results 

• Other

• Mobile: Some travel may be required 

#LI-PDBA1

Job Purpose:

Provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the local CCO portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.

Principle Accountabilities and Responsibilities:

Provides Direction and Leadership to one or more LSTs:

Builds effective, high performing LSTs through influence, integration, motivation and optimization of team performance. Embeds the Roche values into the team(s) culture and promotes the team spirit.

• Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals.
• Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST.
• Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized.
• Liases with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic area and study specific training.

Establishes Study Timelines, Budget, Resource, Risk and Quality Plans:

Provides the GSM with feedback from the local CCO perspective into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.

• Oversees project, protocol, site feasibility and determines site selection and patient allocation (total and annualized) with local CCO and the HQ study (GSL and GSM).
• Analyzes results of project, protocol and site feasibility testing, and provides country feedback or recommendations to SMT.

In accordance with the overall project plan, establishes and maintains accurate study level plans in PlanSource.

• Develops local CCO scenario plans that deliver the studies on time, with the most efficient use of budget and resources.
• Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSM.
• Develops and manages local CCO budget/financial plan, and forecasts using appropriate tools, ensures the LST(s) has the appropriate resources to effectively deliver high quality studies on time and within budget.
• Responsible for ensuring site level contracts are completed.
• Provides input from a country/region perspective into development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring for the local CCO via the GSM.
• Provides input on local requirements for biologic sample plan to the Global Biosample Specialist.
• In collaboration with the GSM and where necessary, PDQ, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the local CCO and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the studies.
• Provides content review and input into the global communication plan.
• Develops local LST communication plan.

Is accountable for the development and active management of the study patient recruitment strategies in the local CCO.

• Develops country recruitment plan for the local CCO and manages patient recruitment strategies.

Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.

Is accountable for the selection, training and management of external suppliers supporting the local CCO.

Manages the Delivery of Study Activities in Order to Meet Study Plans:

Is accountable for all local CCO regulatory, ethical and administrative submissions.

• Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH/GCP requirements, and applicable Roche process/procedures.
• Ensures protocol adherence and consistency of study processes and procedures across all  local CCO investigational sites.
• Ensures studies in the local CCO are performed and conducted in compliance with ICH-GCP guidelines, Roche SOPs, local operating guidelines and all applicable regulatory requirements.
• Ensures patient safety and data quality maintained, and that any concerns are escalated appropriately.
• Ensures monitoring reports are timely, reviewed and takes appropriate actions for follow up on site issues.

Ensures that data is delivered in accordance with established dataflow timelines.

• Ensures that trial management tracking tools (e.g. CTMS/CTP) and systems are populated and maintained.

Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in local CCO Investigator Meetings as necessary.

• Leads and or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e. LST meetings, Investigator Meetings, Monitor’s Workshop and CRO training).

Implements the country-level recruitment plan.

Monitors progress against LST goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.

• Chairs LST meetings, ensuring appropriate follow-up is taken on action points.
• Provides the SMT (via the GSM) with regular status updates with regard to local CCO recruitment and investigational sites.
• Communicates regularly on country/region study(s) status and escalates unresolved issues appropriately to the Country Head, Line Manager and or Team Leader.
• Ensures use of site recruitment plans.
• Maintains tracking of study status.

Oversees the management of the local CCO studies budget.

Identify Areas of Best Practice and Process Improvements:

Leads the evaluation of standards across one or more LST(s) with the objective of enhancing quality, productivity and efficiency.

• Proactively incorporates learnings and recommendations from study debriefs and best practices.
• Maintains oversight and ensures consistency across studies within a project at the local CCO level.

Qualification and Experience:

• Education and relevant working experience: University degree or equivalent in a medical/science-related field and or 5 years proven experience in Clinical Research/Development or related industry.

• Able to communicate clearly and accurately in both written and spoken English.
• Demonstrated ability to interact with different professional levels of the research community.
• Strong leadership skills developed through leading multi-functional matrix study teams through all stages of clinical studies.
• Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units.
• Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
• Experience influencing and negotiating at all levels to achieve team delivery.
• Excellent written and verbal communications skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organization.
• Demonstrated ability to prioritize and manage multiple tasks.
• Self-motivated and achievement driven.
• Strong computer skills – experience using various computer applications including spreadsheets, emails, word-processing software.
• International travel required.

The Biosample Operations Manager (BOM) is accountable for the execution of the biomarker strategy that includes the planning and coordination all operational activities required for the collection and delivery of clinical trial samples (Biomarker, PK and PD) for assigned studies. The BOM is an integral part of the Study Management Team (SMT) and provides operational/ project management expertise as it relates to sampling, site and patient logistics,  and vendor management to ensure deliverables to the SMT or biomarker scientist provided for analysis.  The BOM works closely with the Clinical Trial Leads/ Managers, CRO partners, Site Monitors, Data Management, Biomarker Scientist, etc. to ensure the study protocol and overall program deliverables are met.  

·        Accountable for planning, organizing and overseeing the collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to  assay laboratories to ensure timely delivery and optimal analyzable quality. BOM will also oversee the assay laboratory and ensure delivery of assay results and is the key contact for the assay lab.

·        Determine timelines and all internal resource needs for all biosample operational activities, ensure these are included in study plans and are appropriately tracked

·        Write the Study Sample Management Plan, a functional deliverable to the SMT, to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type.

·        Provide input to clinical study protocol and ICF to review for collection and analysis rationale, feasibility of biological sampling and alignment with Roche policies and study/ program plans.

·        Utilize operational and project management skills to think through issues to ensure deliverables met; Raise issues to the Sr. BOM program leader, Biomarker Scientist, or SMT as required

·        Maintain oversight of all study biosample operational activities (for agreed samples) and regularly report on status (including sample collection and reconciling against consent; Sample reconciliation activities as required) 

·        Accountable for providing answers to ethics questions with regard to repository samples and Roche policies

·        Ensures study adherence to ICH/GCP and SOPs

·        Identifies areas of best practice and process improvements

Skills:

·        Proven clinical development experience of working in teams running human clinical studies (phase I-IV), monitoring clinical studies or experience of working in clinical studies at an investigator site

·        Proven clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.

·        Proven critical reasoning skills including the identification and resolution of complex problems

·        Detail oriented with the ability to work independently and manage multiple competing priorities

·        Proven ability to work successfully under pressure

·        Proven planning, organizational and time management skills

·        Proven ability to successfully achieve results within a multi-cultural and geographically diverse team

·        Proven effective communication and presentation skills

·        Proven effective influencing skills

·        Proven ability to build and maintain effective working relationships.

Education:

·        Life sciences degree or higher

Note that this position can be filled in South San Francisco, Basel or Welwyn Garden.

Genentech/Roche is seeking an Assistant, Associate or Medical Director to participate in the development and execution of clinical initiatives within the hematology group in late stage development oncology, specifically on the venetoclax global development team. Venetoclax is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein. In collaboration with AbbVie, venetoclax is being evaluated in a robust development program as a single agent or in combination with other medicines.



As Associate Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within the Late Development Oncology organization. You will also participate in developing the long-range strategic plans for the molecule.

Key Accountabilities:

Assisting in the overall management, planning, evaluation and documentation of projects and studies. Participation in on-going medicine development activities including:

• Developing and writing clinical plans and protocols ensuring scientific integrity.
• Preparation of regulatory documents and interaction with global regulatory authorities
• Monitoring and reviewing clinical data for safety and ongoing study conduct
• Analysis, presentation and interpretation of study data, with integrated assessment as compared with published data
• Participation in the preparation of abstracts, posters and presentations for scientific meetings, congresses, and interactions with Key Opinion Leaders
• Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations​

​Qualifications

MD with Board Certification or eligibility in Hematology or Oncology and clinical practice experience required as well as strong scientific competence demonstrated by peer reviewed publications or production of clinical expert reports.

• Minimum of 3 years experience in clinical research required with experience in the pharmaceutical industry preferred, or deep expertise in hematologic malignancies in an academic research setting
• Past work experience of confirmatory drug development and evidence of having played a significant part in the preparation of international regulatory submissions and work with health authorities a plus; exceptional candidates without this level of experience may be considered on an individual basis
• Work with health authorities in outcomes measures, presentations, negotiations and submissions are important
• Demonstrated ability to interact effectively in a multifunctional multinational team setting
• Understanding of the business and regulatory aspects in pharmaceutical drug development

To be successful in this role, you will have the following skills and experience:

• Solid experience in medical research including experience in conduct of global clinical trials
• Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents
• Good communication and collaborative skills with experience at working with cross-functional and external groups, including researchers, clinicians and other stakeholders
• Proven track record of delivery of experimental or novel studies
• Confidence at presenting at internal and external strategy meetings

#LI-PDKT1

#asco19

The manufacturing technician is responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems in a cGMP manufacturing environment. The individual will operate production equipment for our Cell Culture, Purification, Bulk Processing, Filling, Inspection and/or Support Services groups. This may include culture growth monitoring, process monitoring, in-process sampling, harvesting operations, protein purification, bulk formulation, fill line operations, lyophilization, bulk freeze/thaw, transfer operations, inspection, and equipment set up/ changeover. May also perform preparation of media, raw materials pre-weigh kits, and buffer solutions. The individual will be required to work in and maintain a clean room environment with aseptic processing in accordance with Standard Operating Procedures (SOPs). Must maintain batch records and associated documentation to comply with regulatory requirements and current Good Manufacturing Practices (cGMP).  Area of work must remain in a high state of inspection readiness at all times.  

This position is on the Night Shift (Thursday, Friday, Saturday, Alternating Wednesdays 7:00 pm - 8:00 am)

Responsibilities

• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Troubleshoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use automation to perform production operations.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production
• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.
• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Troubleshoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use automation to perform production operations.
• Provide support to Manufacturing to meet production demands
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production
• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.
• Follow established safety and environmental guidelines and procedures for all work performed.  Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Foster a positive safety culture in which no one gets hurt.

Qualifications

• Bachelor's degree preferably in Life Sciences or engineering with 3 years of relevant experience, or Associate's degree and 5 years of experience, or High School diploma and 7 years experience.
• Biotech certificate from approved program desirable.

• Ability to understand high levels of automation and technical process knowledge within area of responsibility.

• Background in fermentation, purification, or fill/finish operation strongly preferred.

• Background on equipment set up and change over desirable

• Excellent oral and written communication skills.

• Problem solving skills.

• Lean production system experience desired.

• Capable of writing detailed reports and summaries.

• Familiarity of computer-based systems.

• Detail oriented documentation skills.

• Communicate effectively and ability to work in a team environment.

• Professional interpersonal skills.

 Physical Demands/Work Environment/Safety Considerations

• Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours.

• Expected to be on feet for 8 to 12 hours a day.

• Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.

• Able to lift and carry up to 40 lbs. Push and/or pull with force of 50lbs with full body, and Push/Pull force of 24lbs with arms only may be required.

Working within a clean room environment requires: 

• Gowning in the form of hospital scrubs, coveralls, gloves, and steel toe boots. 

• No makeup or jewelry can be worn when working in the cleanroom environment. 

• Comfortable working in areas with large mechanical equipment, process piping, pumps, pressurized vessels, which can occasionally create a loud working environment.

• Must wear personal protective equipment in accordance with workplace hazards.

• Work with hazardous materials and chemicals. 

*Only local candidates being considered.

The Maintenance Specialist performs electrical or mechanical troubleshooting to determine problems in non-functioning electro-mechanical equipment used in the manufacturing process. He or she is expected to be able under minimum guidance to dismantle, adjust, repair and assemble equipment according to layout plans, blueprints, operating or repair manuals, rough sketches or drawings. The individual should also be able to use test and diagnostic equipment to perform checkouts, rebuilds manufacturing equipment as required, and may perform equipment modifications as directed by Manufacturing Engineers.

This position is for the Night Shift.

Job Responsibilities

• Understand controlled environment and aseptic principles
• Adhere to manufacturing safety regulations
• Comply with current Good Manufacturing Practices
• Adhere to proper documentation (manufacturing tickets and stand operating procedures)
• Maintain clean room aseptic processing qualification
• Participate in on-going training programs to enhance technical proficiency
• Set up production equipment for manufacturing continually refine and quantify set up parameters
• Provide feedback to supervisor for performance evaluations
• Coordinate work assignments
• Evaluate jobs that require more than the typical skills; make recommendations of methods to accomplish the assigned task
• Train Technicians
• Posses a strong working knowledge of processing equipment and a good understanding of repair procedures
• Participate in shift exchange meeting, and confirm assignments with operations supervisor
• Respond to emergency call-in when regularly scheduled backup personnel are not available
• Perform initial diagnosis and assignment and escalate as necessary
• Ability to use verbal and written language to make presentations and prepare reports
• Proficient in the use of all manufacturing and department safety equipment
• Ability to provide leadership to groups or teams
• Ability to fully utilize (Word, Excel, email) and work from Standard Operating Procedures (SOPs)
• Detailed orientated individual with demonstrated good record keeping practices
• Knowledge of cGMP’s and PM SOPs
• Clean, prepare, and operate filling equipment.  Participate in aseptic processing and filling and pharmaceutical product
• Participate in the implementation of 5S
• Complete and review production documents in real time
• Perform basic math
• Ability to work with minimal supervision is a must
• Some flexibility on over time as needed to support the team

Qualifications

Education and Experience

• High School diploma and 5+ years relevant experience, or Associates/Technical degree and 3+ year relevant experience in an industrial/manufacturing maintenance role with demonstrated strong mechanical aptitude
• Strong interpersonal skills are a must.
• Proficiency in both oral and written communications is essential
• Successful demonstration of teamwork and technical expertise
• Strong interpersonal, communication, and time management skills

Work Environment/Physical Demands/Safety Considerations

• Be able to lift 35 lbs
• Be able to work flexible hours, and occasional overtime
• Be able to work extensive hours while standing

*Consideration for local talent only.

We are looking for a highly motivated Senior Software Development Engineer/Software Architect to lead data solutions and integration initiatives for current state industrial automation platforms and future single use technologies. You will be involved in architecting, developing and optimizing the data collection approaches and visualization.

The Software Developer will provide technical expertise to the customer-facing solutions supporting the South San Francisco Production and PT Development customer base. This position will collaborate with IT/Automation counterparts on decisions around data warehouse/data lake solutions. In addition, this position will continue the evolution, implementation, and support of existing data tools while developing strategies for migration towards innovative solutions leveraging industry trends and best practices.  The Software Developer will work with the internal and external existing development team(s) to deliver the full stack of applications and adopt COTS technologies from enterprise Automation and Data Solutions to enable data visualization from manufacturing and level 4 systems (i.e ERP, LIMS).

Key Responsibilities:

• Develop a comprehensive and deep understanding of the data we work with and foster learning with colleagues using tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately.

• Stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches.

• Plan for data identification, collection and processing; assess effective ways of presenting and delivering the results to maximize impact and interpretation; implement and/or oversee ensuring compliance with applicable pharma industry regulations and data standards.

• Collaborate and contribute to functional, cross-functional, enterprise-wide and networks.

• Foster learning within the organization on data sources and processing

• Contribute to the development and execution of departmental goals and initiatives

• Provide leadership and guidance to fellow developers and the customer base

• Participate on the SSFP data steering team for use case creation and requirements definition.

• Responsible for designing, prototyping, developing and unit testing solutions for projects, maintenance and enhancement releases.

• Create and maintain technical specifications, system interface diagrams, unit testing scenarios and system support documentation.

• Interface with vendor support, system administrators, DBA’s and internal application support teams to resolve system issues.

Qualifications

• Bachelor degree in Computer Science, Engineering or other relevant discipline

• 8+ years of technical leadership and architecture experience in software development with a variety of languages (Python, JavaScript Node/React/Angular, Ruby, C#)

• Distributed systems design experience and experience integrating multiple systems using enterprise integration patterns and standard methodologies

• Good understanding of secure cloud design (across Infrastructure, Platform, Application and Data)

• Have designed and developed APIs and micro services and released them using automated CI/CD pipelines

• Experience as a full stack engineer comfortable with JS frameworks as well as API/microservices development

• Experience in relational database with deep understanding of SQL and NoSQL databases

• Ability to coach/mentor engineers and budding technologists, provide technical direction, perform design/code reviews and champion engineering best practices

• You have experience building cloud native applications and solutions in an agile manner using DevOps concepts and principles.   (AWS, GCP and/or Azure, MultiCloud, etc.)

• Experience in BioTech/Pharmaceutical industries desirable though not required

• Experience working with teams using continuous integration, continuous deployment, and automated testing and agile software development tools (Jira, GitHub, Jenkins, etc.)

• Experience in integration technologies (e.g. SOA/ Web services: REST, SOAP, XML, JSON, Messaging, File Transfer)

• Knowledge of large scale data lake/ data warehouses and ETL/ELT data processing pipelines

• Knowledge of Automation Industrial Control system communication protocols  (e.g. Modbus, profibus, OPC DA, OPC UA, etc.)

• Knowledge of Data Historian (OSI PI or Aspen)

• Familiarity with Automation Distributed Control System (DCS) and Manufacturing Execution Systems (MES) for data extraction, contextualization and visualization of manufacturing process data

• Experience in web technologies (e.g. HTML, CSS, JavaScript). Javascript frameworks like Angular, React, Ember, Polymer, Backbone or similar

• Excellent written and verbal communication skills

• Demonstrate customer focus and proven ability to work in a fast paced environment

• Must be self-starter with passion for continuous self-improvement

#LI-PTD-JM1

Job Summary :



This position is mainly responsible for supporting the sales process for Clinical Laboratory IT solution as well as after sales support for Point-of-Care IT solution.



Main Tasks & Responsibilities :



• Performs the technical consulting work in selling Clinical Laboratory IT solutions of Roche Digital Diagnostics portfolio.

• Gathers and assesses customer needs, both business and technical.

• Generates IT solution advice, proposals, presentations, and other customer communications.

• Supports the IT product evaluation in pre-sale stage.

• Creates an appropriate implementation plan with timelines.

• After sales support for Point-of-Care IT solution, including hardware/ software installation, customer training, troubleshooting, maintenance, etc.

• Represents as a technical expert for customers; Conduct external trainings for customers, distributors and internal training for relevant employees.

• Work closely and collaboratively with cross functions to combine resources, and drive win-win solution.

• Interacts directly with Line managers to identify new marketing opportunities, prepares regular marketing activity reports and responds to questions from the sales team.

• Timely report customer complaints/ problems to global case management tool seeking for the cause of the problem; expediting correction or adjustment; following up to ensure resolution and execution of required corrective actions to fulfill customer needs.

Education :

Bachelor Degree or above in Information Management, Computer science and Information Engineering, Bioengineering, Medical technology or equivalent.



Experience :

Minimum 2 years of mixed experiences in Healthcare IT, technical sales, and product management.



Language Skills :

Fluent English in listening, speaking, reading and writing.



Specific Knowledge & Skills :

• Core competency

1) Achieving Results: Holds self-accountable for meeting commitments.

2) Technical and Business Expertise: Applies emerging knowledge and trends in one’s area of expertise to improve results.

3) Teamwork and Collaboration: Establishes strong collaborative relationships.



• Solid IT technical knowledge: HIS/LIS, HL7, web application in the cloud, Networking, SQL server, programming language (Python, etc.)

• Project Management Skills

• Effective Communication Skills

• Presentation Skills

• Ability to work independently and being part of a team

• Growth & Innovative Mindset

Primary duties consist of the application of systems analysis techniques, including consulting with users to determine hardware, software or system functional specifications for client computing technologies. Develops and tests customized and automated configurations and monitoring capability specific to business needs. Creates documentation and training material and trains support personnel. Evaluates, maintains, modifies and documents client computing device changes and root cause analysis. Provides tier-3 technical support, guidance and expertise for projects and initiatives. Can independently make decisions that impact the project level and influence decision makers. Acts as team lead supervising other team members and able to represent manager in meetings making decisions relating to area of subject matter expertise.

Job Responsibilities:

• Troubleshoot multiple computer platforms: Windows, Macintosh, Linux, and Mobility Devices

• Support GxP systems and devices in QC laboratories

• Strong understanding of lab environments, GxP, system validation procedures

• Partner with QC personnel for CSV activities

• Project Manager for global IT initiatives and project documentation

• Lead and Deliver technical solutions for IT lab systems

• Coordinate with other site and corporate IT staff in the resolution of issues. Ensure that resolutions are consistent with standards and do not introduce additional conflicts

• Document resolutions, workarounds, and frequently asked questions for problems and service requests

• Execute the delivery of services per Service Level Agreements to customers in support of a 24x7 mission critical environment

• Manage user accounts, access rights, device and print queues

• Support Patching / Security for All Lab systems

• Keep current documentation on systems, such as hardware and software manuals, system site guides, change control, license agreements, and service contracts

• Communicates information, issues and potential solutions across project teams directly to customers

• Ability to work in a team environment or independently with minimal or no supervision

• Take the lead and represent departmental interests on project teams

• Identify, develop and implement process improvement initiatives

• Ability to influence key decisions within areas of expertise

• Recognized as an expert in many specific technology areas

• Establish a collaborative network of resources (which include RSC, LSA, FPP, Remote Site IT, Shared Service Centers, etc.)

• Mentor and develop peers

• Assist with new service pilots, deployments, and configurations

Serves as an HPSM SME:

• Technical point of escalation
• Understands and adheres to incident management, request fulfillment, and knowledge management processes
• Problem/Escalation for specialty support team
• Ensures tickets are assigned and routed to the correct groups to ensure compliance with departmental Service Level Agreements (SLAs)
• Identify trends for incident tickets that have breached
• Works with solution owner SMEs to document resolutions, workarounds, and FAQs within knowledge management solution articles
• Evaluate New Technology and make recommendations

Qualifications:

• BA degree in Computer Science or equivalent experience

• Minimum of 5 years of related experience.

• Appropriate certifications for desktop and applications support

• Must have: in-depth knowledge of PC and Mac software and hardware for both desktop and laptop machines, in-depth knowledge of Microsoft Office suite of applications, a good understanding of Group Policy Objects and locking down workstations.

• Complete understanding and application of tools, principles, concepts, and techniques related to requirements, data, usability and process analysis. Intermediate level knowledge of other related disciplines.

• Outstanding customer service and interpersonal skills.

• Proven ability to work in a team environment.

• Demonstrated skills in developing technical solutions to a wide range of difficult problems Solutions are imaginative, thorough, practicable, and consistent with organization objectives. Skilled in root-cause analysis.

• Communicate clearly with technical and non-technical audiences, both verbally and written. Demonstrated communication and interpersonal skills (oral, written, telephone) including diplomacy, tact, and flexibility to interact effectively and respond to employees and outside contractors with technical and non-technical problems

• Strong organizational skills and ability to prioritize tasks among many competing requests.

• Powershell and other scripting abilities to administer and automate systems.

• Experience supporting mission-critical production systems in an enterprise environment

• Ability to prioritize, plan and report status at the project level. Can frame approaches and timelines for project work, skilled at setting priorities to complete tasks / projects within scheduled time frame

• Strong analytical skills for effective troubleshooting and problem solving

• Ability to encourage others in fostering effective teamwork and actively solicits ideas from others.

• Can lead small projects and mentor/lead individuals in workgroup. Plays lead role responsible for key deliverables (on behalf of multiple resources) on projects. Represents workgroup on project teams and influences the decisions and direction of project. Serves as the “go to” resource for the work group or project team.

• Determine methods and procedures on new assignments and coordinates activities of others in a technical lead role.

• May lead members of their functional team on medium project teams. May act as a team lead supervising other members of their functional group. Able to represent manager at meetings and in making basic decisions. Able to influence key decisions within area of expertise.

Duties and Responsibilities: This position will report to Head of Evidence for Access, Spectrum. Act as the team "go-to-person" for operational or administrative questions or other inquiries

Provide centralized operational support: Act as the Admin team lead for new systems or processes, including providing training and serving as the department subject matter expert when needed

Responsible for maintaining department rosters and related staffing information

Responsible for maintaining assigned CT&D data and reporting duties, such as departmental guidelines, records management and related systems, staffing reports, etc.

Oversee the process for hiring contractors and serve as the single point of contact for USMA for policy and procedure questions

Oversee and coordinate all office space needs, including moves, equipment, and materials

Provides back-up support for and partners closely with the USMA Management Associates to oversee Leadership Team and department-wide initiatives

Streamline and reduce unnecessary administrative or operational burdens from manager and other team members

Assist the assigned team in various administrative or operational activities such as coordinating, scheduling and preparing for meetings or presentations, gathering information and/or conducting analyses needed for the department's work, formatting editing departmental materials, presentations or other documentation, channeling communication between the department and other Genentech groups, planning, coordinating and managing various meetings and events, etc.

Ensure all assigned work is completed on-time and without compromise to quality; fully meeting or exceeding expectations, goals and targets

Supports manager and team in coordination and ongoing management and communication with any external vendors

Where assigned, coordinates departmental or other team meetings and may directly manage all event planning and management activities

Coordinates and schedules travel, accommodation and other requirements Act in complete & total compliance with all laws, regulations and policies

Work collaboratively, effectively and efficiently with all internal/external partners & stakeholders

Participate, as and when needed/appropriate, in cross-functional or other project teams, helping the overall business of USMA to continuously evolve, improve, and excel

The successful candidate will demonstrate the following competencies critical to this role: Technical and business expertise – Applies emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area

Communication – Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness

Managing change – Accepts change as positive and adapts accordingly

Teamwork and collaboration – Creates and atmosphere of openness and truest’ collaborates; offers support and encouragement

Achieving results – Is goal directed and persistent; is accountable for meeting commitments’ recognizes the contributions of peers

You are a person with the following qualifications and experience: unless stated as "preferred" or "a plus," all other criteria are required

Requirements:

Bachelors Degree is a plus 2 or more years' related administrative, operations or project support experience (experience gained in the pharmaceutical/biotech industry is a plus)

Must demonstrate outstanding computer skills and specific proficiencies with Microsoft Word, Excel and PowerPoint

Abilities: Impeccable ethics and integrity

Must be able to demonstrate strong aptitude in the following areas: Time management & organizational skills Follow-up skills; knows how to draw open matters to successful and timely completion

Project management skills: proven abilities to effectively and efficiently manage multiple, often competing, priorities through to successful conclusion

Attention-to-detail Communication skills, both written & verbal Interpersonal skills; has a proven track record of developing and maintaining good working relationships with others internally and externally

Managing confidential and/or sensitive information in a consistently effective manner Orientation to team work: enjoys supporting various internal partners/stakeholders and is regarded as a "team player”

Franchise: Rheumatology

Territories: New Mexico, El Paso, TX Geography includes the entire state of NM. Over night travel required.

The Clinical Specialist, Rheumatology Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent ACTEMRA IV/SC and Rituxan and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable Immunology indications.

Reports to: Division Manager, RAlly Sales

Example Duties and Responsibilities:

• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
• Works collaboratively with cross-functional teams including but not limited to managed care, thought leader liaisons, medical science liaisons.
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Understand how to use/coach to the ACE Customer Engagement Framework
• Business travel, by air or car, is regularly required

Key Competency Profile:

• Technical & Business Expertise
• Inspiring & Influencing
• Achieving Results
• Decision-Making
• Teamwork & Collaboration
• Strategic Agility

You are an individual with the following qualifications and experience:

(unless stated as "preferred" or "a plus," all other criteria is required)

• Genentech sales experience preferred
• Bachelors Degree
• Average of 4 or more years' work experience
• 2 or more years of previous sales experience in the pharmaceutical, biotech, or related industry is required
• Institutional/Hospital sales and/or disease-state experience preferred
• Proven track record of meeting or exceeding objectives & goals
• Previous experience in achieving specific sales plans or other financial targets is preferred

NOTE:

This is a remote position.

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page at https://www.gene.com/careers

#LI-COMMHC1

The Systems Pharmacology Group in the PKPD Department at Genentech, Inc. is seeking

a Quantitative Systems Pharmacology Modeling & Simulation Scientist who is driven to

enhance drug development through mechanistic modeling of biological systems. The

Translational and Systems Pharmacology Group at Genentech was initiated in 2012 to

lead both (1) preclinical & translational PKPD modeling of biologic therapeutics, and (2)

systems modeling to support all stages of research and development across molecule

types/formats.  Our group is comprised of scientists with PhDs in engineering and

pharmaceutical scientists with expertise across mechanistic modeling and simulation,

computational algorithm and tool development, and translating complex biology into

mathematical models.  We work closely with collaborators across all disciplines in

therapeutic areas such as oncology and cancer immunotherapy, immune and

inflammatory disorders, ocular disease, neurological disorders, and more. 

Communication and collaboration skills are thus critical skills.  The group has a

significant external presence, with a growing list of publications in highly regarded

journals in the field, numerous oral presentations, academic seminars, and workshop

leadership.  Our members are leaders of various interest groups, conference

programming committees, and working groups in the field of pharmaceutical modeling

and simulation.  In addition to our application of systems modeling approaches in

support of drug development, we are also committed to the development of new

technical approaches, algorithms, and tools to advance the field.

Responsibilities

The Scientist/Senior Scientist will be responsible for developing and applying models of

complex systems such as tissue and cell dynamics and intracellular signaling in various

therapeutic areas including immune & inflammatory disease, oncology, and other

disease areas. The successful candidate will have responsibilities developing QSP models

in the context of specific molecule or therapeutic area needs, conducting in silico

research to inform project team goals such as target/compound evaluation, biomarker

and diagnostic investigation, human protocol determination, and combination therapy

identification. The candidate will also have responsibilities using PKPD modeling and

simulation to support large-molecule preclinical and translational efforts, with

continued support as needed through approval. Maintaining close and effective

partnerships with other preclinical and clinical PK/PD and biomarker scientists, safety

scientists, research scientists, clinicians and project teams will be essential. An

additional component will be the presentation of results at cross-functional teams,

department meetings, review committees, and conferences. Qualified individual will

also be responsible for overseeing the strategy and implementation of systems

modeling efforts by other scientists across projects.

Qualifications

Ph.D in chemical, biomedical, or other relevant engineering fields, pharmaceutical

sciences, or a related discipline. Typical post-PhD experience requirements for Scientists

is ~3-6 years, and for Senior Scientists is ~7 or more years. Exceptional candidates with

less experience will be considered for Associate Scientist position. Candidates will have

will have a proven track record and publications applying systems modeling and

simulation approaches to biological systems and/or drug development either in industry

or academia. Proficiency with systems modeling approaches such as differential

equation, logic, stochastic, agent-based, or other advanced mechanistic modeling

approaches is essential, as is experience with relevant software or programming

languages (e.g., Simbiology, MATLAB, R, or C). Experience with modeling and simulation

of large molecule PKPD is valuable but not required, as is familiarity with the biology of

one or more disease areas. The candidate must have excellent communication skills and

the ability to work independently and effectively on interdepartmental project teams to

plan, organize, assess and perform model-based analyses. Leadership skills are highly

desirable.

We have an opportunity for a talented Researcher to join our efforts to explore the development of new therapeutic modalities within the Early Discovery Biochemistry Department. Specifically, you will be helping us to develop a new technology that will enable the discovery of peptide-based macrocycles for targets of interest across a wide range of therapeutic areas. This work will include peptide display experiments, biochemical methods, PCR/qPCR methods, large-scale data analysis, and designing/implementing/analyzing in vitro biochemical and biophysical protein/peptide assays. Specific projects will involve collaborative interactions in a multidisciplinary group and will require regular project meetings and presentations including potential regular travel to external partners. This is a technology development position that will require critical thinking, flexibility, multitasking, and the ability to learn and develop new techniques.


Qualified candidates will have a Ph.D. in biochemistry, molecular/structural biology, bioengineering, biophysics or equivalent education and experience with a strong publication record in relevant journals. Experience in display technologies (phage, yeast, mRNA, ribosome), small molecule screening technologies, DNA-encoded library (DEL) development and screening, and/or assay development is a plus. The successful candidate must be motivated, thoughtful and capable of working both independently and in a collaborative team setting. Strong problem solving, analytical, organizational, and communication skills are also required.

#LI-GREDES1

RESPONSIBILITIES:

The Clinical Pharmacology Department at Genentech, Inc. is seeking Ph.D. level Associate Scientist, Scientist, or Senior Scientist who is driven to use pharmacometrics to advance the clinical development of novel drug candidates. This individual will be responsible for the development and implementation of Modeling and Simulation (M&S) strategy, in order to ensure that the right drug is administered to the right patient at the right dosing regimen. The modeling and simulation activities include population PK/PD models,  disease models, statistical models, physiologically-based PK (PBPK) models, quantitative system pharmacology (QSP) models, clinical trial simulations, literature meta-analysis, machine learning/deep learning, and other state of the art quantitative techniques. Key technical responsibilities are to organize, execute, and report M&S independently, as well as to present work at cross-functional teams, department meetings, senior management review committees, regulatory interactions, and scientific conferences. Other responsibilities will include planning, writing, and reviewing relevant clinical documents such as study protocols, analysis plans, reports, and regulatory documents. These will be accomplished by working in close partnership with other scientists in Clinical Pharmacology, Clinical Science, Biostatistics, Preclinical and Translational PK, DMPK, Safety Assessment, Biomarker, Diagnostics, Regulatory, RWD (Real World Data), and other functions on project teams. Qualified candidate could be responsible to manage employees via direct and/or matrix management system, providing oversight of the strategy and implementation of M&S by other scientists across projects.

REQUIREMENTS:

Candidates should have solid expertise in quantitative pharmacology and strong hands-on modeling and simulation skills. Rich hands-on experience with NONMEM, R, SimBiology, Simcyp, GastroPlus, , and/or other modeling and simulation software is required. Experience with clinical trial simulation, optimal design, advanced mechanistic PK/PD modeling is highly preferred. Experience in interaction with regulatory agencies is highly desired. The candidate must have excellent communication and interpersonal skills and the ability to work independently and effectively on interdepartmental project teams. For experienced candidate, he/she should have demonstrated impact on drug development through quantitative approaches. The candidate must have strong leadership skills and the ability to influence. People management experiences are a plus.

EDUCATION:

A Ph.D. or equivalent in Pharmacometrics, Biostatistics, Biomedical or Chemical Engineering, Applied Mathematics or Physics, Pharmaceutical Sciences, or related discipline with 0+ year (for Associate Scientist), 3+ years (for Scientist), 7+ years (for Senior Scientist) of industry, regulatory, and/or related post-doctoral Modeling and Simulation experience is required.

#LI-GREDNN1

#ASCPT1

#devsci

The Department of Oncology Biomarker Development (OBD) is seeking a highly talented and driven Scientific Manager to contribute to biomarker development and translational research in the Signaling Franchise.

Specifically, this individual will conduct in depth analysis of biomarker data from various stages of clinical trials to facilitate clinical development, in addition to preclinical studies, to gain insight of resistant mechanisms of experimental cancer therapeutics and to help inform novel combination strategy.

The successful candidate is expected to have a strong understanding of the cross-talks between intrinsic cancer signaling and immunity with expertise in cell-cell interactions, genomics and transcriptional analysis, and is expected to be highly collaborative and have excellent oral and written communication skills.

Responsibilities

• Lead biomarker related studies in conjunction with clinical trials as well as in depth data analysis and interpretation for experimental cancer therapeutics
• Manage and Conduct the generation and analysis of large-scale, genomic, phenotypic, and molecular data from preclinical and clinical studies.
• Must able to design, conduct, and analyze laboratory experiments in the areas of interaction of oncogenic signaling and cancer immunotherapy.
• Collaborate with scientists across different departments at Genentech to accomplish translational research and development goals.
• Managing the collaborations with external investigators and organizations in disease specific translational researches
• Participate in and contribute to team meetings by presenting experimental plans and Results
• Publish in high quality scientific, technical or medical journals and represent OBD externally through presentations at key internal and external meetings, and conferences

Qualifications

• PhD in a relevant scientific field (e.g. pathology, molecular biology, cancer genetics, cancer biology, molecular oncology)
• 5+ years postdoctoral experience in basic or translational research either in an academic and/or industry setting
• Ability to independently design and execute well-controlled experiments.
• Strong data science skills, such as bioinformatics, biostatistics and data visualization, are essential
• Strong cancer immunology background is a plus
• Experience in clinical drug development and clinical biomarker analysis are beneficial
• Experience and understanding of biomarker development, particularly in Oncology is beneficial
• Outstanding presentation and communication skills
• Strong organizational skills, including the ability to manage multiple priorities and adhere to timelines.
• Highly collaborative and willingness to work with colleagues in different time zones

#LI-GREDTS2

#AACR19

The Position

Summary

The QC Protein Analytical Testing lead is a 5x8 position that will support analytical testing support across a 7-day operation to perform batch release, process and facility support testing to meet customer needs, method transfer, method validation.  This role is also expected to represent the department in regulatory agency, internal and partner audits.  The individual will also provide technical expertise to resolve routine to complex QC issues and to develop and conduct training for QC personnel.  Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.

Responsibilities:

• Support method transfer and method validation activities for analytical methods.
• Support equipment qualification and support global equipment standardization efforts within QC network.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Be accountable for behaviors described in Genentech's Core, Common and Critical competencies.
• Drive to identified systems and procedural gaps, and lead/implement improvements.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases and potent compounds.
• Provide technical and compliance guidance on analytical test methods.
• Review, evaluate and approve test data against established criteria.
• Assist in the resolution of Out of Specification (OOS), complaints, discrepancies and CAPA (corrective actions preventive actions).
• Review, provide input, and approve technical/investigation reports.
• Recommend improvements to identified systems and procedural gaps, and lead/implement improvements.
• Participate in internal and external audits and regulatory inspections.
• Provide input and help author protocols and reports within specified Quality Control discipline.
• Execute testing for validation and qualification studies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

Requirements:

Education, Experience, Knowledge, and Skills:

• BA/BS degree (preferably in Analytical Chemistry) and 5 - 8 years relevant experience in the bio/pharmaceutical industry, or an equivalent combination of education and experience.
• Experience in performing microbiological product testing in a cGMP environment
• Experience in performing chemical product testing in a cGMP environment
• Solid understanding of cGMPs or equivalent regulations
• Ability to communicate clearly and professionally in writing and verbally
• Ability to work off-shift and weekends as required
• Ensure that cGMP compliance is followed3

Work Environment/Physical Demands/Safety Considerations:

• Work in office and laboratory environment
• Lift up to 25lbs may be required
• Ability to sit, stand and move within work space for extended periods
• May be required to sit at a computer terminal for extended periods

Please note the shift for this position is Monday- Friday 1:00 PM - 10:00 PM

The Position

Summary

The QC supervisor’s primary responsibility is to supervise and develop the staff to perform routine activities in accordance with cGMP regulations and Genentech standards to meet departmental and organizational goals.  This is a 5 x 8 day swing position and entails managing employees across a 7-day operation to perform batch release, process and facility support testing to meet customer needs.  The supervisor is also expected to represent the department in regulatory agency, internal and partner audits.  The individual will also provide technical expertise to resolve routine to complex QC issues and to develop and conduct training for QC personnel.  Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.

Responsibilities:

• Head of Product Analytical Chemistry QC Operations
• Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel.
• Manage and communicate compensation related information per company guidelines.
• Set objectives and tasks for staff and regularly review staff progress in meeting objectives.
• Supervise routine activities and complex issues
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Genentech's Core, Common and Critical competencies.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• Meet scheduled on time performance metrics.
• Provide technical and compliance guidance on test methods.
• Review, evaluate and approve test data against established criteria.
• Assist in the resolution of Out of Specification (OOS), complaints, discrepancies and CAPA (corrective actions preventive actions).
• Review, provide input, and approve technical/investigation reports.
• Recommend improvements to identified systems and procedural gaps, and lead/implement improvements.
• Participate in internal and external audits and regulatory inspections.
• Provide input and help author protocols and reports within specified Quality Control discipline.
• Supervise testing for validation and qualification studies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

Requirements:

Education, Experience, Knowledge, and Skills:

• Head of Product Analytical Chemistry QC Operations
• BA/BS degree (preferably in Chemistry or another Life Science) and five (5) years relevant experience in the bio/pharmaceutical industry, or an equivalent combination of education and experience.
• Sound knowledge of cGMPs or equivalent regulations
• Have strong knowledge of wet chemistry (e.g., HPLC, UV Spectrophotometry, Karl Fisher, etc), in-process control testing, final product testing, assay troubleshooting and Out-of-Specification investigations
• Have working knowledge in microbiological test methods to support facility and utility monitoring,
• Ability to interpret and relate Quality standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business objectives
• Working knowledge in 5S, SAP, Labware LIMS and  TrackWise preferred
• Prior supervisory experience preferred
• Ability to work off-shift and weekends as required

Work Environment/Physical Demands/Safety Considerations:

• Work in office and laboratory environment.
• Lift up to 25lbs may be required.
• Ability to sit, stand and move within work space for extended periods.
• May be required to sit at a computer terminal for extended periods.