• Primarily accountable for ensuring the technicalsuccess of the maintenance  operations and the performance management of aworld-class maintenance  organizational unit associated with thecommercial manufacture of all GMP products.  
• Manage activities of designated functional unit inmaintenance  shift or unit supervisors/leads who direct daily activities.  
• Identify the technical, procedural andequipment issues that may compromise production and compliance, working closelywith cross-functional groups to identify and implement solutions.
• Manage and resolve technical andcompliance issues with Quality, Manufacturing, Manufacturing Sciences andTechnology, Reliability Engineering, Engineering, & EH&S.
• Develop weekly and monthly goals andschedules and set priorities for supervisors/leads. Evaluatesupervisors’/lead’s performance; ensure supervisors’/lead’s fair and timelyevaluation of the performance of their staff.
• Responsible for identifying andimplementing improvements in staff development in areas such as cGMP training,technical skills, safety, performance management.
• Implement and follow through oncorrective and preventative actions for variances.
• Represent the department in reviewingand approving all maintenance related documentation requiring approval such asprocess validation protocols and final reports, planned and unplanned variancereports, documentation change requests, engineering and facility changerequests, and validation protocols.
• Ensure that all operations areperformed with 100% compliance to documentation cGMP standards.
• May prepare department budgets andstrategic staffing plans.
• Assist Associate Director with settingbusiness goals and cross-functional deliverables.
• All employees with jobs that requireaccess to the Warehouse must be able to pass the Transportation SecurityAdministration (TSA) Security Threat Assessment (STA).
• Promotes a safety culture that supportcontinuous improvement in the EHS management system through activecommunication and functional area participation in site safety teams ensuringthe safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt.
• Manage assignments that are complex innature where independent action and a high degree of initiative are required inresolving problems and developing recommendations.
• Manage problems where analysis ofsituations and data requires an evaluation of intangible variables.  
• Exercisesindependent judgment in developing methods, techniques and evaluation criteriafor obtaining results.

...

Clinical Specialist, Tarceva/Zelboraf
Knoxville, TN or Asheville, NC

The Clinical Specialist, Franchise 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 the assigned GNE brand(s) 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 therapeutic area/disease state.

Reports to: Division Manager, Franchise 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
*Monitors operating costs and compliance with territory budget
*Complies with all laws, regulations and policies that govern the conduct of GNE activities
*Business travel, by air or car, is regularly required
...

Solution Architect – Regulatory

 

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

 

The Position

 

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

...

Brand Protection is a proactive initiative to protect patient safety, supply chain integrity and brand reputation by identifying and acting on individuals or entities that intend to mislead healthcare practitioners, caregivers, patients, trade organizations or the public at large for their own illegal gain.    

The Senior Manager, Brand Protection reports directly to the Director, Interactive Marketing and is responsible for overseeing the Brand Protection Core Team, managing key external partnerships, directing ongoing surveillance, executing the communication strategies, analyzing the impact of these entities and reporting initiative progress to Commercial leadership.

MAJOR RESPONSIBILITIES:

• Direct online and offline monitoring of suspect products, diversion, trademark infringement, and promotional abuse in the US market, maintain expert familiarity with core industry trends, including customer, competitive and enforcement dynamics in order to adapt and support various aspects of Brand Protection.
• Serve as the single point of contact for orchestrating Brand Protection activities across the Commercial organization.
• Leads a multidisciplinary, cross-functional Brand Protection Core Team that includes Quality, Trade, Security, Commercial Law, Patent Counsel and Customer Operations. 
• Leads the development of a communication plan that keeps both the CLC and the Commercial organization at large appropriately informed of Brand Protection initiatives and progress reports.
• Track online pharmacies selling Genentech products illegally and analyze behaviors relative to Rx requirements, trademark/copyright infringements, product format/packaging and pricing.
• Execute monthly communication strategies (warning letters) and track response to key actions.
• Prioritize monthly targets for suspect product purchase, secure senior management approvals, and oversee the purchase process. 
• Build and manage relationships with key Federal Enforcement Agencies  (FDA OCI, ICE, DOJ) and partner organizations (NABP, PSI, CDC).
• Develop and manage budgets/resource requests for all Brand Protection activities. 
• Serves as a member of the Counterfeit Core Team.

CAPABILITIES:

• Strong leadership presence with proven ability to influence stakeholders at various levels of the organization (both US and Global); capacity to work collaboratively with peers in pharmaceutical industry and engage support/ alignment.
• Ability to build, lead, motivate and represent matrix, cross-functional teams without direct reporting authority.  
• Superior verbal/ written communication abilities with demonstrated success at communicating complex situations and action plans in a simple, structured and easily absorbed manner.
• Willing to champion new ideas or positions to meet key goals and doesn’t abdicate responsibilities.  Can negotiate skillfully in tough situations with both internal and external; U.S. and Global groups.  Is comfortable around, and influential with, higher management.
• Experience in forecasting and building predictive models to understand impact of diversion on legitimate trade channels.
• Basic understanding of online promotional practices, search engine marketing and social media environments.  Understands consumer behavior and response dynamics.
• Strong commitment to patient safety and compliance requirements.  Maintain thorough understanding of U.S. compliance requirements and legitimate channel definitions.

...

Genentech is seeking a qualified Scientist or Senior Engineer to be responsible for laboratory robotics and high throughput technology for the Early and Late Stage Pharmaceutical Development departments.  The robotics will provide a critical tool to enable high throughput formulation development for projects at various stages of clinical development, from early development to licensure.  The successful candidate will be responsible for designing, developing, and implementing robotics and high throughput technologies and associated automated workflows.  Following initial implementation, the candidate will ensure full integration into the departments.  Thereafter, the candidate will be responsible for iterative improvements to existing applications, and the introduction of new applications to enhance the capabilities of the departments.  The candidate will manage a team of individuals to accomplish this work.  Responsibilities will include close and effective collaboration with formulation scientists, interpretation of data produced by robotics, troubleshooting of instruments and methods, drafting of technical documents, and supporting regulatory filings.

...

Group Product Manager, Erivedge Key Customer Team

The Group Product Manager (GPM) will report to the Erivedge Marketing Director. This position offers the opportunity to lead the brand analytics, access initiatives and key customer relationships for Erivedge, a first-in-class hedgehog pathway inhibitor indicated for the treatment of advanced basal cell carcinoma (aBCC). The role will be accountable for tracking performance indicators, implementation of access-to-care and practice management tactics and thought leader engagement, while leading a team of two marketers. Specific responsibilities include development of quarterly business reviews, thought leader development, advisory activities, peer-to-peer promotions, managed care / access programs and providing appropriate commercial perspective to publication planning and medical teams.

Additional responsibilities of this position include: 

• Collaborate with MCCO to ensure understanding and execution of brand strategies within appropriate payer and field-based tactics
• Lead initiatives with MCCO to optimize patient flow from script to shipment 

• Manage development and implementation of thought leader strategies including major conference activities, internal management tools, and participation/involvement in key promotional activities
• Collaborate with field sales, TLLs, marketing colleagues on thought leader activities
• Collaborate with BioOncology partners for implementation of major meeting activities

• Collaborate with Medical Affairs, Clinical Science, and Advisory Board Services to manager advisor activities
• Lead data integration team toward developing and tracking key performance metrics in collaboration with market planning, marketing science, sales operations and forecasting/business analytics team
• Lead and motivate team of two direct reports and manage all activities and professional development
• Managing brand budgets 
• Maintain strong relationships with colleagues in research, clinical, medical affairs
• Actively participate in Oral Oncolytics and BioOncology initiatives and programs
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

Successful candidate should possess:

- Solid understanding of specialty biotech/pharmaceutical marketing and sales

- Solid experience with proven results in managing and motivating direct reports in a marketing role 

- Strong analytical and communication skills

- Direct experience managing through leader relationships and/or extensive knowledge access dynamics for part D drugs

- Proven ability to develop relationships with sales force and across departments for support of strategies 

- Proven ability to work in a fast-paced, collaborative environment which requires significant cross-functional and cross-brand coordination and teamwork

- Proven ability to work in teams and also work autonomously 

- Experience in working with commercial promotional review committees

- Proven track record of adhering to timelines and budgets

...

Global Competitive Intelligence Manager/Sr Manager, Infectious Deceases

Based in South San Francisco or Basel

Global Competitive Intelligence Manager/Sr Manager - Key Activities:

¿ As a member of the Global Strategic Analytics Team, the successful candidate will be an important strategic business partner to the global marketing teams; International Business, Lifecycle, Disease Area Strategy teams and Roche Partnering.
¿ Works in close collaboration with the International Business Analyst, generating synergies within Strategic Analytics for GPS and the Roche organization
¿ Responsible for cross-functional collaboration to determine competitive landscape for both development and marketed products
¿ Defines and frames business challenges and decision requirements with key stakeholders based on a clear understanding of client needs and priorities. Works with key internal stakeholders and International Business Analyst (IBA) to develop, update and answer key intelligence topics and questions
¿ Leads the collection of competitor information and competitive intelligence from internal and external sources (both published and unpublished) and undertakes the synthesis, analysis and dissemination of this information to support strategic decision making.
¿ You will be responsible for conducting international Competitor Intelligence projects using a variety of methodologies.
¿ Monitors key competitors and ensures timely dissemination of critical intelligence and associated recommendations to appropriate stakeholders.
¿ Leads the coordination, planning and execution competitive coverage at conferences
¿ Proactively promote best CI practice within Roche
Creates an environment of strong team spirit, excellent communication, high motivation and inspires other team members to achieve goals in line with Roche strategies

...

Purpose:
The Senior Financial Analyst position resides within the Commercial Finance Operations group and plays a key role in the direct support of the Commercial brand teams’ product marketing activities. The Senior Financial Analyst (SFA) supports the brand teams by: (i) driving month-end close activities through reviewing expense accruals/prepays (ii) financial review of new SOWs/ contracts and purchase requisition/PO set-up (iii) supporting the Commercial planning processes i.e. forecasts updates and tactical plans (v) financial performance reporting and variance analysis (vi) actively leads/participates in process improvement projects within the Commercial Finance Operations team. 

Responsibilities:
Directly support multiple/complex brand teams’ marketing activities, meet with stakeholders on a regular basis to gain budget allocation and financial spend input, and to provide regular updates on the status of spend as compared to product marketing budgets and forecasts.
¿ Prepare monthly financial reports and variance analysis comparing actuals to latest forecast (or latest Basel forecast) and budget, and provide insight into remaining forecasted spend and other ad hoc analysis to understand trends of their direct product marketing activities.
¿ Take on other brand/functional P&L responsibilities to further develop knowledge of the business.
¿ Ensure contract policies and processes are followed in a timely and compliant manner focusing on the financial review of vendor agreements and statements of work (SOWs).
¿ Support Commercial Finance’s ICFR assessment by reviewing / researching the list of out-of-compliance transactions and ensuring that material product marketing arrangements with vendors are covered by purchase orders or other approved contracts and are accrued as appropriate in the financial statements.
¿ Identify areas of inefficiency and ineffectiveness and lead projects that improve Commercial financial processes; partner with colleagues, customers and Commercial Finance to assess and implement recommendations in a timely and effective manner.
¿ Proactively and accurately communicate on a regular basis with partners in Commercial Finance (Finance Managers and Leads), brand teams, other Commercial organizations, corporate departments (e.g. Legal and Finance) and external vendors.
¿ Identify and articulate improvement initiatives aligned with group and departmental goals and actively lead and/or participate in process improvement projects, as required.
¿ Serve as a subject matter expert on Commercial finance processes, leveraging in-depth knowledge of Commercial and cross-functional systems, including SAP, T2E and TM1.
¿ Take on the “buddy” role to onboard/train new hires and acclimate them to the commercial funding, contract logistics, budget tracking, purchase order set-up, accrual and forecasting processes and related accounting policies and procedures.

...

Your responsibilities will encompass all the activities involved in carrying out Process Development experiments with bacterial and CHO culture processes. This will include cleaning, sterilization, batching, and inoculation of bioreactors; preparing media and solutions, performing cell counts, operating harvest equipment, process and equipment troubleshooting, and experiment data recording and collection. Operate computers for process control and data entry. Partner with other shift personnel, and staff to carry out complex experiments for the development, characterization and validation of products and technologies. This job includes the improvement and creation of standard operating procedures, implementation of new technologies and equipment, participation in continuous process improvement efforts, and coordination of processes and experiments.

Skills:
The ideal candidate will display a strong focus on safety, quality, detail and results. Must be organized and capable of multitasking, have effective problem solving abilities, and demonstrated mechanical aptitude. Can proficiently perform aseptic operations with a high degree of consistency and quality. Communicates clearly, concisely and professionally in both verbal and written manners. This position requires the ability to effectively work in a team environment with diverse skills and objectives. Successful candidates must have a high level of demonstrated initiative, be self directed, exhibit flexibility in work approach, demonstrate strong follow through and accountability, and embrace positive change.

...

This role will be the strategic business partner to local leaders and leadership teams within the PD client organization, influencing the overall people strategy and ensuring effective execution of HR responsibilities. The person in this role will consult, advise, coach and partner with the business on people and organizational needs – ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy. This role also partners with local leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

• Act as key local HR point of contact, trusted advisor, and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business while taking into account the broader implications (e.g. Group HR strategy, other functions).
• Contribute to the business strategy. Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & Group HR strategy and goals (i.e., actively sponsoring and leading goals at LT level).
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, functional, and site HR initiatives.
• Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business. Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development. Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services based on costs, ratios and appropriate Key Performance Indicators. Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelines.

...

Franchise: Rheumatology

Product:  Rituxan RA

Territory: N.Minnesota / N. Dakota

 

 

The Clinical Specialist, Franchise 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 the assigned GNE brand(s) 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 therapeutic area/disease state.

 

Reports to: Division Manager, Franchise 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
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required

 

NOTE:

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.

...

The Head of Planning  is responsible for leading and managing the PTD planning network globally, establishing a vision and mission for the group with roles and responsibilities for local and global activities, establishing and managing PTD planning business processes in close collaboration with PTDx functions, portfolio reports and interfaces with the PlanSource Steering group, ensuring resource allocation transparency. Interacts closely with PTD functional planners, PTD finance, TDLs and TDT PMs, PTD leadership team and key stakeholders within the Research and Early Development, Development and Technical Operations organizations to ensure strong partnership, excellent communication flow, resolve issues and understand inputs affecting the technical development planning activities. This position requires strong leadership, collaboration, negotiating and influencing, strategic thinking, organizational and communication skills.

MAJOR RESPONSIBILITIES

• Lead and manage the global PTD Planning  group. This includes establishing a vision and mission for the group and the global PTD planning network with clear roles and responsibilities for local and global activities, establishing and maintaining PTD planning business processes and planning operations in strong partnership with the PTD functional planners, and conduct regular alignment meeting with the PTD planner community ensuring resource allocation transparency, PTD finance, TDLs and TDT PMs, yearly maintenance of generic plans in Plansource with eRAM update, establishing training for planning functions and groups within PTD, resource planning data analysis and scenario planning to support PTD strategy initiatives. Supports budget cycle from the PlanSource perspective
• Accountable for projects and portfolio reports and portfolio analysis. This includes maintenance of reports, creation and/or retirement, and distribution of reports to meet the business needs of PTD and its stakeholders. Creates strong partnership with Global Portfolio Management aligning the PTD reporting with Corporate portfolio.
• Represents PTD on PlanSource Steering group and drives for PlanSource operational processes updates and change management within PTD.
• As a member of the PTDM leadership team, works collaboratively to establish priorities and directions for PTDM globally. Contributes to the development of department business initiatives and facilitates their implementation.
• Fosters a culture of high performance, trust and collaboration across all PTD planning stakeholders. Builds and cultivates a strong network among PTD functional planners, Finance groups, PlanSource expert groups, TDLs and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.  Helps to surface, analyze and resolve planning related issues and resource conflicts.
• Recruits, retains and develops talent. Establishes and implements training and development plans as required, providing constructive feedback as well. Supports the creation, use and continuous improvement of standard planning systems, tools and processes. Interacts closely with TR&D functional leaders and key stakeholders within the Research and Early Development, Development and Technical Operations organizations.

...

  The Product Quality – Biologics group is part of IMP QA.  The department is responsible for the product quality for biologics and antibody-drug-conjugates in the global Roche network throughout the development lifecycle to commercialization.  As a member of the IMP Product Quality group, the Sr. Quality Product Leader serves as the single point of contact on the technical development teams and is accountable for driving the quality activities for the teams.  This position must effectively communicate timelines and issues to Quality to ensure successful manufacturing, product testing/release and regulatory filings.    Additionally the position must partner with other organizations throughout Roche Global Pharma Technical Operations, including but not limited to: QA Operations, Commercial Quality, External Quality, Pharma Technical Development (PTD), and Regulatory (PTR).  This position will primarily support project activities during late stage development and the process handover from development to commercial as part of new product commercialization.

Responsibilities
•Participate in regular technical development team meetings and provide clear and timely feedback to the teams.•Communicate timelines and issues to all relevant Quality departments in a timely manner.
•Engage and collaborate with partner groups (e.g., within and outside Quality, external partners, etc.) and across global sites in the Roche network to ensure production, testing and release, and regulatory submission timelines are achieved without compromising product quality. 
•Proactively work with technical development teams, commercial counterparts, and senior management to identify and escalate project quality risks with the goal of delivering a robust process appropriate for commercial filing acceptable to Health Authorities and provides reliable products after launch
•Provide high level oversight of PC/PV, method validation and transfer activities during commercial filing preparation, and ensure timely escalation of timeline bottlenecks to senior management
•Lead Quality investigations, including developing proposals for resolution of product-impacting Quality issues and presentation for endorsement to Quality Review Boards, and oversight of outcome of appropriate CAPA’s associated with product-impacting investigations.

...

Market Planning Manager, Oncology - Global Product Strategy

Participate actively in global commercial planning efforts by providing objective, in-depth analyses on current and future markets, product performance, customers, and competitors. Additionally, identify critical business issues and opportunities for growth, collaborate with Genentech/Roche teams, and work to embed an external market point-of view into the strategic direction of the company.

This Global Market Planning Manager / International Business Analyst position is a global role based in South San Francisco. This individual will be a member of a global cross-functional team focusing on development of our pipeline products and will be required to travel domestically and internationally.

KEY ACCOUNTABILITIES:
*Proactively and continuously assess the relevant marketplace and its dynamics, customers and competitors to enable strategic decision making regarding brands and business operations.
*Business partner within assigned cross-functional teams: developing strategic insights and providing in-depth product and marketplace knowledge.
*Ensures alignment across internal partners, stakeholders, and senior management.
*Leads initiatives to facilitate growth and development of the Global Strategic Analytics team
*Responsible for new market and product opportunity assessments.
*Creates, manages, validates, and refines forecasts (product and market)
*Communicates revenue forecasts and assumptions to internal partners, stakeholders, and senior management.
*Develops and implements market research plans, in conjunction with cross-functional teams.
*Provides analytical input to the Disease Area Director during due diligence for in-license opportunities and liaises with partnering groups.
*Actively contributes to cross-functional or other project teams, helping the overall business evolve, improve & excel.
...

How do changes in genome sequence affect biological function and disease? We cannot assay billions of mutations, but evolution has already tested the impact of changing every base in our genomes. Comparative genomics now offers a key to break this ‘evogenetic code’ by exploring which mutations survived evolution and how they correlate with the rest of the genome and on the biology of the organism.

 

We are looking for a smart, skilled, and highly motivated postdoctoral fellow to lead our exploration of genome evolution by reconstructing ancient genome sequences and modeling mutation patterns and evolutionary constraints. This will have potentially profound implications on understanding human sequence variation (familial and somatic), on understanding protein functions, and on relating genomics to organismal biology.

 

Our postdoc training encourages exposure to multiple projects, and we also have remarkable opportunities in the integrated analysis of cancer genomes. The Department of Bioinformatics and Computational Biology at Genentech is one of the largest bioinformatics research groups with a remarkable breadth and depth of expertise, a strong team environment, deep links to our research colleagues, and a uniquely strong opportunity to help develop breakthrough new medicines. The Manning lab (http://manninglab.org/) focuses on understanding of biological function and disease through evolutionary genomics analysis.

...

This is a term position for approximately 9 months

Responsible for implementing and maintaining the validated state of automated systems at Genentech’s Oceanside Facility. Expected to be knowledgeable of and work within GMP regulations.  Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site.  Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing.  This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.  

Job Responsibilities

Essential

Manage and track the Validation program and assigned validation projects for automated systems and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
Generate, review, approve and maintain Qualification Project Plans and Summary Reports and other validation lifecycle documents for automated systems.
Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs) for automated systems.
Manage protocol execution, perform data review and manage deviation resolution.
Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
Strong understanding of commercial production environment and requirements.
Evaluate and audit the current validated status of automated systems.  Make suggestions for improvements as well as ensure system is operating in compliance and validated state.
Present validation packages for automated systems as required for audits and/or regulatory inspections.
Perform role of subject matter expert and assess change control and discrepancy events for automation systems.
Review automation validation lifecycle documents for compliance with CFRs, corporate requirements, and site procedures.
Lead group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

...

We have an opening for a talented Scientist to join our Biochemical and Cellular Pharmacology Department. The successful candidate will be responsible for supporting mass spectrometric characterization of antibody therapeutics and antibody drug conjugates. More specifically, the individual will focus on developing, validating and executing various mass spectrometric assays to evaluate antibody therapeutics and antibody drug conjugates from both in vitro and in vivo studies to support lead-finding/optimization efforts in the context of multidisciplinary project teams. Working with automation and bio-informatics experts, the individual will be expected to implement robust and high throughput sample preparation as well as data analysis workflows for mass spectrometric assays. The candidate will have the opportunity to conduct detailed data analyses and will present these data to project teams and senior management. In addition, the candidate will function as part of a multi-disciplinary project team that will coordinate with protein science, chemistry, in vitro and in vivo groups to advance lead molecules of the projects....

An Associate Scientist position is available in the Protein Analytical Chemistry Department (within US Biologics Pharma Technical Development, PTDU).  The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  This will include development, optimization and validation of analytical methods to be used for characterization and/or quality control of therapeutic protein and ADC candidates.  This individual will provide analytical support to different functional groups in PTDU and actively participate in project teams consisting of members from all areas of process development. This individual may be responsible for managing 1-2 research associates, depending on experience level.
...

Product Manager / Senior Product Manager

The Product Manager, Lytics Cathflo Marketing reports directly to the Group Product Manager and is responsible for:

Management of all peer-to-peer Cathflo programs including speaker's bureau, Cathflo Nurse Trainers, Cathflo Nurse Liaisons and national webinars.
Development of relevant medical education content and patient case studies for inclusion in peer-to-peer programs. Evaluation of nurse thought leader engagement strategy in partnership with the field and other internal partners.
Evaluating new means of marketing broadly to nurses, with a goal of driving an increase in habitual CVAD line assessment. Planning and execution of annual advisory boards in support of Cathflo, as needed. Contribution to the development and execution of the 3-year brand plan, and the 1 year tactical plan for Cathflo.

The successful candidate must have:

• Proven strategic agility in a complex marketplace
• Demonstrated experience in the development and execution of a sales or marketing plan
• Proven ability to partner effectively with field sales and sales leadership
• Considerable skill in influencing without authority
• Ability to provide rationale-based, succinct and persuasive oral & written communications
• Working knowledge of product development, regulatory and clinical affairs
• Demonstrated ability to establish thought leader and other relevant stakeholder relationships
• Strong analytical and project management skills, including previous experience working with budgets and analyzing market research results

...

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

 

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

...