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We are seeking a dynamic and flexible self-starter who is looking for a fast paced and high energy work environment. Responsible primarily for administrative support of the VP of Immunology and Infectious Diseases in gRED Research, as well as the staff of the Infectious Diseases, Translational Immunology, and FACS Lab Departments. 

 RESPONSIBILITIES:

• Ensure VP and Department Directors are fully supported in seamless fashion

• Work with the Research administrative professional team to coordinate their activities and promote team cohesion and communication

• Partner with manager and other staff to maximize the efficiency of the work group

• Participate, plan, coordinate and prioritize work within and across departments by providing project leadership, direction, training, and assistance to others

• Interface with other departments throughout Research, Development and the global company

• Responsible for a wide range of administrative duties

• Must be able to prioritize, problem-solve, and work independently, practice strong organizational skills pro-actively, and exercise judgment and discretion regarding sensitive/confidential and proprietary information

• Maintain multiple complex calendars; coordinate department activities; plan in-house and offsite meetings; schedule candidate interviews; organize travel for staff and invited guests; arrange teleconferences, process expense and payment reports; filing and organization of documents; maintaining staff records and office supplies; maintain standard database tracking tools; utilize various corporate software applications

• Consistently works on complex assignments requiring a high degree of technical background to resolve issues; Frequently required to solve problems at times without relying on precedent or supervisory review; may review decisions made by others 

• Acts as the departmental "go-to-person" for general operational or administrative questions

• Streamlines unnecessary administrative or operational burdens from manager and other team members 

• Assists 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 or editing departmental materials, presentations or other documentation, channeling communication between the department and other Genentech groups, etc. 

• Responsible for training new team members on company and departmental administrative and general processes, systems, practices, tools and standards 

• Responsible for maintaining a fully accurate and up-to-date departmental roster, complete with all employee and other key departmental information

• Coordinates departmental recruitment activities 

• Ensures assigned team has the most current office equipment and materials at all times and appropriate to the team's work

• Coordinates and manages any office moves

• Supports 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

Job Responsibilities:

• Operate all utility systems and utility subsystems at Genentech, SSF

• Ensure all utility systems and utility subsystems at Genentech, SSF are operated and maintained in the following manner:

- All preventative maintenance is performed at the appropriate interval and is completed by the assigned due date (SOP 500.032).

- All equipment remains in its designed and/or validated state at all times

- All equipment operation is in accordance with Federal, State, local, and Genentech regulations, procedures, and policies

• Ensure/maintain all utility equipment areas in a constant state of inspection readiness; specifically but not limited to the following:

- Cleanliness

- Personnel and Equipment Safety

- Compliance to cGMP requirements

• Continuously evaluate the operation of all utility systems and utility subsystems at Genentech SSF.  Identify specific process improvement needs and provide recommendations for system upgrades.

• Identify training deficiencies, provide recommendations for training and where applicable provide training.

• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability. Submit appropriate change requests through the Facility Services Document Tracking Database to correct any deficiencies discovered.

• Provide operational support to Facility Services, Engineering, Manufacturing, and Research and Development. This support must not interfere with the normal day to day operation of any utility systems and utility subsystems at Genentech SSF.

• Perform Confined Space Entry on an as needed basis.

• Complete preventive maintenance and assigned paperwork in a timely manner following all cGMP documentation guidelines.

• Responsible for gathering and documenting the appropriate information associated with a System Discrepancy, (An event in manufacturing process and/or support system that is outside approved operating parameters or approved procedures).

• Work with various chemicals, steam, pressurized gases/liquids of various temperatures.

• Work in close proximity to moving equipment.

• Conduct work in an FDA regulated environment.

• Must have the ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery.

• Ability to respond to and evaluate a variety of situations involving mechanical, electrical and systems controls

• Ability to perform preventive maintenance and equipment servicing according to Standard Operating Procedures

• Must have general knowledge of shop tool operation and safety.

• Ability to read and Understand P&lDs, work from Standard Operating Procedures (SOPs) and have basic computer skills using word processors, spreadsheets, databases, and email.

• Must be detail oriented and demonstrate good record keeping practices.

• Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.

• Proficiency in understanding of Federal, State, Local and Genentech regulations, procedures, and policies.

• Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range.

• Demonstrate effective communication skills including preparing technical reports, the revision of various procedures (SOPs, IPs, etc..) and the Utilization of the EMPAC/GMMS work order system.

• Ability to work with minimum or no supervision.

 # manufacturing

• Direct staff and oversee pipeline-enabling functions, including process impurity analysis, and critical reagent characterization, with methods that include chromatography (HPLC, UHPLC, LC-MS/MS), CE (iCIEF and mCE), Immunoassay (ELISA & Western blots), moisture testing (Karl Fischer, FT-NIR) and trace metals testing (ICP-MS and ICP-OES).
• Direct staff and oversee high throughput analytical assays for bioprocess projects, including process characterization, method development and validation, and support of technical development teams.
• Provide strategic direction for Process Related impurity analysis, including appropriate method selection, scheduling, and resource allocation.  Interact with stakeholders (e.g. PTR, MMTech) and serve as primary department contact for process impurity investigations.  Serve as a subject matter expert for impurity analysis to senior leadership in PTDU and PTR.
• Establish strategies and objectives as needed to achieve department and company goals, and regularly interact with other directors in ADQC, PTD, and other stakeholder functions.  
• Review, edit, and approve internal reports, quality documents, regulatory submissions, and external presentations and manuscripts.  Specifically, the Director signs Quality documents as the representative of the AO management.
• Manage performance and development of personnel to ensure achievement of organizational and department goals and a productive environment.  Work to ensure safety and environmental goals for the department and individuals within the department are being met. 

• Lead a group of about 50 staff, including scientists, research associates, and contractors.  Provide clear objectives, explain the “why’s”, establish priorities, motivate for high productivity, track progress, and evaluate performance, in order to meet organizational and corporate goals.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic personal development goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development, and growth opportunities.
• Manage and administer all aspects of people processes related to employee life cycle. This includes the selection, hiring and training of personnel on company department policies, systems and processes. Manage and communicate compensation related information per company guidelines
• Ensure that projects and initiatives are completed on time.
• Manage budget and resource allocations, manage resource forecasting, and monitor and control expenditures against the department budget
• Review, approve, and sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions
• Be accountable for behaviors described in the Roche Leadership capabilities
• Lead scientific innovation efforts to identify, evaluate and implement novel technologies  
• Interact and collaborate effectively with staff and directors of related functions and stakeholders (cell culture, purification, formulation, commercial quality and manufacturing, regulatory)
• Influence industry best practices and Health Authorities on trends and policies by actively participating in conferences and workshops
• Expected to exhibit strong teamwork and collaborative skills with strong verbal and written communication

Perform full range of general office responsibilities to departmental operations that include, but not limited to, set up and maintain high volume files, basic spreadsheet assignment, and reference documentation preparation. This individual will work closely with other department staff members to contribute to the efficiency of the work group and provide back up support. This individual may directly support functions within the US Drug Safety organization including but not limited to:- Compliance and Training - Market Research and Patient Support Programs - Case Management - Business Operations 

1. Establishes training schedules in collaboration with the mentors and ensures each new hire is assigned their correct training for their role 
2. Ensures training is complete and appropriately documented 

Position Purpose:
To provide strategic oversight for the preparation of regulatory clinical and safety documents covered by Integrated Documentation Teams, working in close partnership with medical/scientific and business leaders across functions. To be accountable for timely delivery of high-quality, compliant regulatory documents, applying project management expertise and contributing to functional excellence through process management. Leading a global matrix team of Regulatory Documentation Scientists, the Integrated Documentation Team Leader may work on the most complex projects to support and coordinate assigned deliverables and to guide the efforts of multiple staff members. The Integrated Documentation Team Leader may represent the department in key internal and external meetings, in communications, or in other ways.

Major Responsibilities and Accountabilities:

People Leadership, Management and Development

• Leads a global matrix team of Regulatory Documentation Scientists (Integrated Documentation Team) in support of multiple products within a single therapeutic area or cluster of therapeutic areas, or within a particular stage of development (e.g., early stage development); ensures appropriate planning and resourcing by working in collaboration with Functional Managers, members of the Resourcing Team, or other members of the Leadership Team.
• Ensures the application of global PDRD standards developed through Functional Excellence and promotes knowledge sharing and information exchange within the Integrated Documentation Team.
• Supports Filing/Suite Leads in the planning and development of submission timelines for production and review of regulatory documentation to ensure alignment with overall project timelines and regulatory authority deadlines.
• Oversees and mentors Integrated Documentation Team members and provides guidance on projects within the remit of the Team.
• Develops and maintains therapeutic area expertise among Integrated Documentation Team members and ensures the timely communication of new and/or significant scientific findings relevant to the assigned therapeutic area(s).
• Ensures that Integrated Documentation Team members prepare documents in line with PDRD quality standards and regulatory requirements.
• May contribute to recruitment activities and lead onboarding and ongoing staff training.

• Oversee the development and implementation of Quality Control strategy and activities for the Hillsboro Technical Operations manufacturing facility in Oregon (HTO). Oversees generation, review and compliance of locally developed and approved procedures with company-wide quality policies and standards.
• Direct staff and operations within Quality Control groups in accordance with cGMP regulations and the Roche/Genentech’s standards
• Establish strategic goals and objectives and maintain full strategic responsibility for Quality Control for the site.
• Monitor and ensure the performance and delivery of results for the Quality Control testing laboratories
• Provide leadership and guidance to immediate staff performing Quality Control activities. Support can include sampling, sample management, testing of DS, DP, and finished goods (release) as well as raw materials, in-process, devices, direct materials, utilities and environmental monitoring of classified areas as defined by site requirements. 

Leadership and People Management

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• As a leader within Quality Site Leadership team, drive network activities and alignment, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the Quality Control function.
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning. 

• Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures. 
• Direct QC Staff in the timely completion of testing (e.g. DS, DP and FINP release, raw materials, in process samples, utilities, direct materials, medical devices, environmental monitoring, process and cleaning validation.).
• Provide QC staff with technical guidance on test methods and relevant procedures
• Ensure timely generation and reporting of test results in support of manufacturing operations (e.g., hold testing). 
• Ensure calibration and maintenance of laboratory equipment and systems.
• Ensure support of manufacturing operations through troubleshooting, transfer activities and other product lifecycle testing.         
• Ensure that data, documentation, and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
• Ensure system, computer, change control, and analytical data is reviewed, evaluated and approved against established criteria
• Ensure data is generated, documented and reported following cGMP procedures
• Direct the review and approval of all applicable Quality Control documents and ensure documents are updated
• Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods 
• Lead Analytical transfers and local analytical method verifications as required by sites
• Direct QC Staff in the timely resolution of issues, including discrepancies, investigations, and implementation of CAPA (corrective actions preventive actions)
• Escalate any potential quality issues revealed during QC testing or processing of products (e.g., QRB), especially quality or regulatory issues with the potential to affect product quality or regulatory compliance. 
• Support regulatory inspections and partner audits, approvals of protocols and reports of third party QC laboratories 
• Liaise with regulatory agencies and external sources regarding issues affecting product quality as QC SME

• Global QC, Other site QC leaders, ATC/ATL, Manufacturing, Local MSAT
  

• Embody PT lean leadership principles and methods
• Be an active and visible change agent, fostering a flexible and open mindset to new opportunities and continuous improvement
• Ensure timely and effective communication
• Create an environment of strong team spirit and high motivation
• Be a strong representative of HTO in the PT learning network, promoting best practice sharing and adoption aimed at continuously improving network standard processes
• Manages and deploys a group of technical training professionals to develop and deploy training across HTO
• Coach and develop staff via effective development planning. Manage the performance planning process for direct reports.
• Coach internal instructors on delivering classroom content.
• Develops and manages an annual site training budget and provides longer-term training budget projections. Manages spending against the approved annual budget. Participate in the business review and budget development process for HTO.
• Active membership on the Business Support & Operational Excellence Leadership Team and the HTO site Extended Leadership Teams

• Leading the development, coordination, delivery and continuous improvement of training programs at the site, including, but not limited to: cGMP operations, business systems, leadership and employee development, program and project management capabilities, organizational change management
• Get insights regarding business objectives, collect and analyze training needs, in development of the training strategy and training programs based on the needs of the organization
• Training administration / logistics, new hire and contractor onboarding and overall training at the site ensuring a compliant cGMP training environment and documentation system across the site, including Manufacturing, Quality, Facilities & Engineering, MSAT and Materials Management
• Actively participate in, and ensure, sharing of training activities within the PT network, evaluate new network training initiatives and local implementation at HTO
• Ensure compliance with global training and development standards and processes and is responsible to represent this system to regulatory agencies
• Actively manage and ensure effectiveness of department work processes and systems, with a focus on continuous improvement.  Develop KPI's that measure the effectiveness of training programs
• Evaluate the effectiveness of learning solutions, platform/system and programs, and ensure their continuous alignment to business goals.
• Remain current in industry and sector best practices and approaches around training development and deployment
• Participate in, and influence, the development of the workforce plan as part of the HTO site strategy and incorporate these elements into the site training programs, in close collaboration with HR and site management.

*** Please note this position is being re-posted to reflect it could be a day or swing shift position.  Also, the position will support all areas of operations and not just Tank Management ***

Main Purpose of the Position:

Main Purpose of the Position: Provide direct manufacturing Quality Assurance support to Production (Inspection, Packaging, Aseptic Operations, and Tank Management) in a GMP environment. Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. Assure compliance with cGMP regulations, Roche / Genentech standards, and applicable Regulatory Guidelines. Solve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Genentech standards. Perform assigned tasks and work to achieve company goals and department objectives.

Job Duties/Responsibilities:

• Follow company policies and procedures. Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Meet assigned targets and timelines with minimal supervision. Prioritize assigned tasks within a fast paced environment.
• Participate in process improvement and system design teams.
• Provide assistance to customers in support of departmental functions. Work with colleagues to maintain cross-functional and cross-site process and procedural consistency.
• Receive specific instruction and work independently to complete tasks.
• Apply basic theory and technical principles to address routine problems.
• Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Sign documents for activities as MQA as described by Genentech policies, procedures and job descriptions. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities. 

Description: 

• Approve discrepancies following cGMP regulations and Roche standards. 
• Approve significant (i.e. OOS) discrepancies and ensure laboratory investigations are thorough, timely, unbiased, well-documented, and scientifically sound. 
• Ensures effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems and improve product and process quality. 
• Manage EM and media fill programs. 
• Perform tasks and work to achieve company goals and organizational objectives. 

Job Duties/Responsibilities:    

• Follow company policies and procedures. 
• Maintain a state of inspection readiness. 
• Provide input to the development of personal performance goals and departmental objectives. 
• Meet assigned targets and timelines. 
• Prioritize assigned tasks within a exciting work environment.  
• We're looking for a team member who is curious and creative and will participate in process improvement and system design teams. 
• Provide assistance to customers in support of departmental functions. 
• Work with colleagues to maintain cross-functional and cross-site process and procedural consistency. 
• Apply advanced theory and technical principles to address routine problems. 
• Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. 
• Sign documents for activities as EQA as described by Roche/Genentech policies and procedures. 
• Be accountable for behaviors as described in Roche values and leadership competencies. 
• You are a thoughtful, creative problem-solver and will perform other tasks as requested by Management to support Quality oversight activities.
  

Technical Duties/Responsibilities: 

• Manage the environmental monitoring (EM) and aseptic media fill programs. 
• Support validation activities for new equipment, facilities and utilities. 
• You are an excellent communicator and will provide technical assessments and approvals for changes to the environmental control program to ensure consistency across manufactured products. 
• You are committed to excellence and will present and provide rationale of environmental control programs during internal and partner audits and regulatory inspections. 
• Provide input in the preparation of regulatory submissions related to the environmental quality of Genentech manufacturing facilities and processes. 
• Provide quality oversight to ensure a compliant EM and pest control program. 
• Perform and assess air flow evaluations. 
• You thrive on collaboration and in a communal environment and will c and author department policies and procedures. 
• You will nurture customer relationships and serve as the Quality representative on cross-functional and multi-site teams.  
• Identify, design, and implement process and system improvements. 
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems. 
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.  
• Serve as a technical subject matter expert (SME) in support of department functions. 

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Establish strategic goals and objectives and maintain full strategic responsibility for the Procurement organization.
• As an extended site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the Procurement organization.
• Proactively promote positive Safety Culture and cGMP operating principles.
• Embody PT lean leadership principles and methods while fostering a continuous improvement mindset

• Responsible for overall procurement activities for assigned categories to assure high level of supplier performance (right quality, supply insurance - OTIF, improving service level, Total Cost of Ownership) in accordance with compliance requirements (Roche Procurement Policy, Directive,Guidelines and local Procurement SOP’s)
• Responsible for management and  execution of the end-to-end Procurement processes which include: sourcing, contract negotiation & management, and Purchase Order Creation, for indirect services and materials.
• Work with Roche leaders and executives, including Plant Management and Site Governance teams to identify strategic procurement opportunities within the business.
• Support and enforce Roche Procurement Policies and cGMP requirements for procured materials and services.
• Establish, build and maintain successful supplier relationships.
• Work with and lead cross functional teams across the network, to identify, develop and drive strategic programs focused on reducing overall cost structure and improved supplier performance.
• Work with network category managers to ensure the alignment of local procurement needs.
• Interface with Service Centers  and develop service level agreements to support outsourced procurement activities.
• Support network level procurement initiatives.
• Interface to global procurement, supplier quality and CMO.
• May Lead local or global projects and/or teams
• Monitor key performance and process health indicators (KPIs and PHIs)
• Secondary Packaging Material Category Management. 
• Asset resale as required.
• Responsible for capital procurement for projects below $10M.
• MRO parts procurement

The Production Maintenance Supervisor will act as a representative for the HTO Production Maintenance Manager to support the timely execution and completion of functional activities and goals. The primary responsibility of this position is to develop, oversee, and manage personnel involved in the Maintenance and Repair of equipment and systems utilized in the manufacturing of marketed pharmaceutical product. 

In addition this position will also work towards the improvement of existing processes as well as develop new processes and capabilities functionally, cross functionally and cross site that will enable achievement of department, site, and corporate goals and objectives.

Supervise the installation, maintenance, operation and repair of all systems, subsystems, and equipment within the Genentech, Hillsboro Oregon facility

Conduct, oversee, and manage work in an FDA regulated environment, adhering to all associated Roche, Local, Federal, and international regulations

Fully meet or exceed assigned expectations

Interface, collaborate and support various groups and organizations within Genentech/Roche as well as external vendors, service providers and business partners to:

• Develop and implement safe work practices
• Establish and sustain clear communication both verbal as well as written
• Optimize equipment maintenance and repair strategies
• Maximize equipment uptime
• Develop equipment life cycle strategies
• Develop equipment user specifications and requirements
• Develop various training and qualification materials for new and existing equipment
• Provide or arrange for adequate training to operations and maintenance personnel as necessary
• Develop and manage equipment maintenance intervals
• Establish and implement maintenance best practices

• Provide leadership, coaching and management to operations and maintenance personnel consisting of various trade disciplines.
• Provide development and career growth opportunities for all assigned employees.
• Communicate clear and objective performance expectations, and provide timely performance appraisals for direct reports. Support continuous training and development of the department.

• Provide project support for process system projects, including coordination and direction of outside engineering, construction and vendor resources as necessary
• Provide Factory acceptance testing support on new process equipment and systems
• Ensure all equipment installations or upgrades meet or exceed all Federal, State, and Local regulations
• Assist and/or Manage specialized maintenance and equipment projects

• Work closely with reliability engineering to develop and implement predictive maintenance techniques and streamline maintenance activities eliminating unnecessary or unsafe maintenance activities
• Working closely with various functional and cross functional personnel to identify root cause of issues and determine proper solution and possible impact
• Sponsor and drive Root Cause Analysis (RCA) activities
• Routinely monitor and analyze system trend data to identify issues or opportunities for system improvement
• Assist the various maintenance groups with the coordination and execution of major equipment maintenance, troubleshooting and repairs

• Recommend, champion, and administer process and procedure improvements, especially with respect to advanced maintenance techniques (e.g., operational checks, return to service requirements, etc.)
• Develop new & analyze and modify existing operational and preventive maintenance procedures and processes

• Prepare and organize technical documentation, reports, DMS, CAPA responses
• Prepare and manage change records per the approved change management system
• Prepare and manage Capital funding requests for small projects
• Complete preventive maintenance and assigned paperwork in a safe and timely manner following all cGMP documentation guidelines

• Oversee the execution of various operation and maintenance activities; ensure compliance to various safety programs such as:
• Lock Out Tag Out
• Confined Space Entry
• Hot Work (Electrical & Welding/Cutting)
• Chemical Handling
• Fall Protection

Ensure all assigned equipment and associated subsystems are maintained in the following manner:

• All Preventative maintenance is performed at the appropriate interval and is completed by the assigned due date
• All equipment remains in its designed and/or validated state at all times
• All equipment operation is in accordance with Federal, State, Local and Genentech regulations, procedures, and policies
• Coordinate contractors who perform repairs, modifications, and installations of various  equipment
• Ensure / maintain all assigned equipment areas in a constant state of inspection readiness; specifically, but not limited to, the following:
• Cleanliness
• Personnel and Equipment Safety
• Compliance to cGMP requirements

The Production Maintenance Supervisor will act as a representative for the HTO Production Maintenance Manager to support the timely execution and completion of functional activities and goals. The primary responsibility of this position is to develop, oversee, and manage personnel involved in the Maintenance and Repair of equipment and systems utilized in the manufacturing of marketed pharmaceutical product. 

In addition this position will also work towards the improvement of existing processes as well as develop new processes and capabilities functionally, cross functionally and cross site that will enable achievement of department, site, and corporate goals and objectives.

Supervise the installation, maintenance, operation and repair of all systems, subsystems, and equipment within the Genentech, Hillsboro Oregon facility

Conduct, oversee, and manage work in an FDA regulated environment, adhering to all associated Roche, Local, Federal, and international regulations

Fully meet or exceed assigned expectations

Interface, collaborate and support various groups and organizations within Genentech/Roche as well as external vendors, service providers and business partners to:

• Develop and implement safe work practices
• Establish and sustain clear communication both verbal as well as written
• Optimize equipment maintenance and repair strategies
• Maximize equipment uptime
• Develop equipment life cycle strategies
• Develop equipment user specifications and requirements
• Develop various training and qualification materials for new and existing equipment
• Provide or arrange for adequate training to operations and maintenance personnel as necessary
• Develop and manage equipment maintenance intervals
• Establish and implement maintenance best practices

• Provide leadership, coaching and management to operations and maintenance personnel consisting of various trade disciplines.
• Provide development and career growth opportunities for all assigned employees.
• Communicate clear and objective performance expectations, and provide timely performance appraisals for direct reports. Support continuous training and development of the department.

• Provide project support for process system projects, including coordination and direction of outside engineering, construction and vendor resources as necessary
• Provide Factory acceptance testing support on new process equipment and systems
• Ensure all equipment installations or upgrades meet or exceed all Federal, State, and Local regulations
• Assist and/or Manage specialized maintenance and equipment projects

• Work closely with reliability engineering to develop and implement predictive maintenance techniques and streamline maintenance activities eliminating unnecessary or unsafe maintenance activities
• Working closely with various functional and cross functional personnel to identify root cause of issues and determine proper solution and possible impact
• Sponsor and drive Root Cause Analysis (RCA) activities
• Routinely monitor and analyze system trend data to identify issues or opportunities for system improvement
• Assist the various maintenance groups with the coordination and execution of major equipment maintenance, troubleshooting and repairs

• Recommend, champion, and administer process and procedure improvements, especially with respect to advanced maintenance techniques (e.g., operational checks, return to service requirements, etc.)
• Develop new & analyze and modify existing operational and preventive maintenance procedures and processes

• Prepare and organize technical documentation, reports, DMS, CAPA responses
• Prepare and manage change records per the approved change management system
• Prepare and manage Capital funding requests for small projects
• Complete preventive maintenance and assigned paperwork in a safe and timely manner following all cGMP documentation guidelines

• Oversee the execution of various operation and maintenance activities; ensure compliance to various safety programs such as:
• Lock Out Tag Out
• Confined Space Entry
• Hot Work (Electrical & Welding/Cutting)
• Chemical Handling
• Fall Protection

Ensure all assigned equipment and associated subsystems are maintained in the following manner:

• All Preventative maintenance is performed at the appropriate interval and is completed by the assigned due date
• All equipment remains in its designed and/or validated state at all times
• All equipment operation is in accordance with Federal, State, Local and Genentech regulations, procedures, and policies
• Coordinate contractors who perform repairs, modifications, and installations of various  equipment
• Ensure / maintain all assigned equipment areas in a constant state of inspection readiness; specifically, but not limited to, the following:
• Cleanliness
• Personnel and Equipment Safety
• Compliance to cGMP requirements

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research- focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

Candidates must be available to work any shift, including weekends, nights and holidays. Currently, this shift is expected to be Swing shift, Wed-Sat. and is subject to change.

• Responsible for the maintenance and calibration of all instrumentation and control system equipment within the Hillsboro Oregon facility to include utilities, Aseptic filling, Packaging, Automated Inspection and QC laboratory instruments.
• Provide complex emergency troubleshooting and complex repairs of all the HTO site control systems and instruments in the areas of Filling, Packaging, Inspection, QC, Tank Management, Utilities, Warehouse and Distribution Center.
• Provide support to engineering and operations in the design, installation, testing, operation and maintenance of Fill Finish manufacturing and support equipment.
• Ensure all assigned equipment and associated subsystems are operated and maintained in the following manner.
• All instrument calibrations are performed at the appropriate interval and is completed by the assigned due date.
• All equipment remains in its designed and/or validated state at all times.
• All equipment operation is in accordance with Federal, State, Local and Genentech regulations, procedures, and policies.
• Ensure / maintain all assigned equipment areas in a constant state of inspection readiness; specifically, but not limited to, the following:
• Cleanliness
• Personnel and Equipment Safety.
• Compliance to cGMP requirements.
• Continuously evaluate the operation of all systems and associated subsystems at Genentech Hillsboro. Identify specific process improvement needs and provide recommendations for system upgrades.
• Identify training deficiencies, provide recommendations for training improvement, develop new training materials and provide calibration OJT training to N1s, N2s and N3s.
• Continuously evaluate all Standard Operating Procedures, engineering drawings and various other controlled documentation for accuracy and applicability. Submit appropriate change requests to supervisor to correct any deficiencies discovered.
• Create new Maintenance Strategy SOPs and Work Instructions as required.
• Continuously evaluate maintenance/calibration practices to eliminate non productive activities and implement productivity enhancements.
• Perform Confined Space Entry on an as needed basis.
• Complete assigned scheduled and corrective maintenance in a timely manner following all cGMP documentation guidelines.
• Work in close proximity to hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery/equipment.
• Coordinate contractors who perform repairs, modifications, and installations of instrumentation, control systems, and associated equipment.• Perform installations of new complex instrumentation and process control equipment.
• Perform complex instrument calibrations in accordance with standard operating procedures.?
• Perform Variable Frequency Drive replacements and configurations.?
• Perform complex configuration of the site’s instrumentation.
• Work directly with Manufacturing, Engineering and various Quality organizations on new system installations or modifications and maximize equipment availability.
• Conduct work in a GMP regulated environment.?
• Participate in functional teams and cross functional teams as instrument subject matter expert support.
• Identify and implement process improvements within functional group which improves inspection readiness, productivity, reduces time bound maintenance, or eliminates non- value added activities.?
• Use project management skills to complete complex improvement projects by their due dates.

Under the direction of the Associate Director of Drug Product Manufacturing, The Head of Lyophilized Product Manufacturing is accountable for the safe, cost-effective, and efficient operation of manufacturing lyophilized drug products at Roche’s Hillsboro Technical Operations (HTO) site in Hillsboro, Oregon, while in full compliance with current Good Manufacturing Practices and Roche’s corporate principles, quality policies and standards.  This position ensures network and market demands are met, safely, in adequate time and quantities, always seeking for balance between quality, competitive cost and time for manufacturing.

Key Responsibilities:

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.
• Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Establish strategic goals and objectives and maintain full strategic responsibility for lyophilized product manufacturing operations at HTO.
• As a drug product manufacturing leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of lyophilized drug product manufacturing operations.
• Proactively promote positive Safety Culture and cGMP operating principles.
• Embody Roche lean leadership principles and methods while fostering a continuous improvement mindset.
• Ensure manufacturing of quality products according to Health Authority and Roche Pharmaceutical Quality System requirements, including Discrepancy Management System, CAPA systems, Quality Risk Management and Technical Change Management.
• Optimize manufacturing output and labor efficiency while meeting required safety and quality levels.
• Continuous improvement of manufacturing procedures and related equipment in collaboration with Manufacturing Sciences and Technology (MSAT), Facilities & Engineering and Quality.
• Participate in the development of manufacturing, productivity, and financial goals and manage operations so that all departmental and site goals are met.
• Ensure cGMP compliance and inspection readiness for lyophilized drug product manufacturing operations at all times. Actively support internal and external inspection activities.
• Ensure the condition of all equipment, premises, and infrastructure in drug product manufacturing is maintained appropriately. This position is the front line owner of manufacturing plant and systems associated with lyophilized drug product manufacturing. Identify, and arrange any necessary repairs, maintenance work or technical or structural reworking within the framework of the respective competences in cooperation with the Facilities & Engineering, and MSAT departments.
• Operate within the validated state of processes and equipment.
• Ensure that staff are appropriately trained and qualified for the activities they perform.
• Support the development of the production plan for lyophilized drug product manufacturing and ensure conformance with production schedules.
• Responsible for IPC analysis and ensuring that the planned production in the area of responsibility can run without delay.
• Further develop the operating procedures and equipment in the area of responsibility in accordance with the state of the pharmaceutical technology, provided that a quality or production improvement can be achieved or a GMP requirement can be met.
• Represent area of responsibility in defining and refining validation strategy, investigations and technical transfers.
• Continuously monitor deviations in the area of responsibility and define and implement sustainable measures to reduce deviations. Promote problem identification and a culture of proactive problem prevention.
• Coach and develop supervisors and junior staff via effective development planning. Manage the performance planning process for all direct reports. Coordinate department level hiring and staffing plans. 

• Able to collaborate with both plant and corporate organizations seamlessly
• Has the passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers
• Embraces World Class principles and behaviors
• Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity
• Is able to provide the leadership necessary to maintain a high performance culture

• Ensure work environment meets Genentech and industry standards
• Create and maintain a safety culture that delivers injury and incident free operations
• Drive achievement of departmental safety performance targets and manage operations so that all departmental, functional and site objectives are met
• Reinforce safety practices/behaviors throughout the shift
• Provide oversight and support to ensure safety improvement initiatives are consistently identify and implemented
• Ensuring that all shift personnel have applicable safety training requirements assigned and completed
• Ensure the facility is always regulatory inspection-ready
• Participate in the development of quality goals and oversee operations to ensure targets and objectives are achieved
• Review trend data to ensure quality compliance and correct negative trends as required
• Reinforce quality practices throughout the department
• Provide oversight and support to ensure adequate quality improvement initiatives are appropriately identified and implemented in a timely manner
• Maximize production output and labor efficiency while meeting required safety and quality levels
• Manage operations to ensure that production, productivity, and financial targets and objectives are met
• Ensure business processes are followed and improved to deliver production performance at Class A levels
• Maximize equipment utilization and Overall Equipment Effectiveness (OEE)
• Apply operational excellence tools to define standard work, reduce process variability and steadily deliver measurable efficiency gains
• Ensure that Continuous Process Improvement teams are supported, trained and facilitated
• Manage the execution of the production schedule and shop order sequencing to optimize use of available capacity
• Maintain data and transactional sources required to support capacity models to understand real time capacity utilization and capability
• Comply with all company policies and procedures related to personnel management
• Manage and mentor the performance planning process for all direct reports to ensure their success Coach and develop leads, specialists and technicians via effective development planning
• Coordinate shift level hiring and staffing plans
• Complete all required training activities (i.e., safety, cGMPs, technical skills, processing operations, etc)
• Ensure lessons learned or best practices are shared across the department
• Leverage knowledge to maximize organizational effectiveness
• Identify and manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production
• Actively manage shift labor, overtime and spending to within the approved budget on an ongoing basis
• Review and approve manufacturing documentation including batch records and SOPs. Review and support closure of discrepancy records
• Participate in strategic planning, objective self analysis for compliance, safety and quality risks, and analysis of operational strengths, weaknesses, opportunities and threats

We are seeking a highly motivated Senior Scientific Researcher with strong interest and expertise in genomics research. The candidate will work in the high-throughput Next Generation Sequencing (NGS) lab which provides support for NGS technology to gRED and develops new applications in the area of genomics. In particular, he/she will primarily provide support and conduct technology development in the area of single cell genomics. You will be involved in all aspects of sample processing, library production, protocol testing and development as well as its automation. Also, you will be involved in the assessment and development of new emerging single cell and other NGS applications for large scale, high-throughput genomics. The successful candidate is expected to independently design and execute experiments, troubleshoot issues, interpret results and give project updates. By utilizing a variety of high-throughput NGS applications, the candidate will also participate in multidisciplinary efforts focused on target identification in support of Genentech’s drug discovery and development.

The Position

The Analytical Operations department prides itself on expertise and leadership in the area of process related impurities, such as host cell proteins (HCPs), host cell DNA, and leached protein A/L. We have an exciting opportunity for a passionate, curious, and spirited scientist to join our effort.

In this role, you will direct and conduct hands-on research to better understand complex impurities, such as HCPs. You will be responsible for developing quantitative methods for large and small molecule process impurities, often requiring the evaluation and comparison of various technologies. Therefore, experience with multiple analytical techniques (eg SPR, ELISA, mass spectrometry) to measure and characterize proteins and other impurities is expected.  You will be expected to help advance the field of process related impurities by publishing research findings in peer reviewed journals and participating in external conferences and working groups.

In addition to hands-on research, you will be involved in directing work of research associates.  This will occur through both direct management as well as matrix leadership, and collaboration with cross-functional colleagues.  You will be expected to critically evaluate and clearly communicate technical recommendations both within the process impurity field as well as to the larger PTD organization.  Therefore, demonstrated experience with developing and leading teams as well as exceptional communication skills are highly desirable.

Our team deeply values integrity and passion. We're committed to providing a supportive work environment and to fostering mentorship and career development for our team members. If you share our values, want to make a difference, enjoy relationship-building, and are dedicated to excellence, we're excited to hear from you!

• Lead and conduct process related impurities research.
• Educate and update AO leadership on process related impurities technologies and other related topics.
• Provide guidance and support to project teams for technical development.
• Participate in AO strategy development and operation management.

# manufacturing

• Perform sample testing in support of process development, formulation screening, product characterization, and comparability assessment according to established test procedures.
• The successful candidate is expected to perform varieties of chromatographic analysis, including reversed-phase high performance liquid chromatography (RP-HPLC), size-exclusion chromatography (SEC), ion-exchange chromatography (IEC), and capillary electrophoresis (CE).
• Other expectations include maintaining timely detailed laboratory notebook, writing pertinent technical reports, adhering to laboratory safety rules, and maintenance of laboratory equipment.

# manufacturing

Description:

The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, validate, and troubleshoot bioanalytical/biological methods to characterize clinical products.

- The successful candidate will be expected to perform the development of bioanalytical binding assay such as Surface Plasmon Resonance (SPR-Biacore) to assess the antibody-target interaction and Fc effector functions of therapeutic antibodies.

- Additional responsibilities may include using automation system, writing data analysis template for new assays, summarizing/presenting data, and supporting collaborations with other groups/sites.

- In addition, he/she will perform sample testing in support of process development, characterization, formulation screens, and stability according to established test procedures and in compliance with cGMP’s.

- Expectations may also include writing S.O.P.’s, test procedures, protocols, and reports, equipment qualification and maintenance, supporting IND/BLA filing and participating in inspection by regulatory agencies.

Location:  South San Francisco, CA

In this position you will take the role of a Technical Regulatory Leader and will be accountable to develop and implement CMC regulatory strategies and submissions to support biologics products in development. Demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork, and communication are required for this role.

You will be tasked to develop complex global regulatory strategies with support from global team members representing both technical regulatory and across various functional departments.

You will be accountable for the timely compilation of all necessary CMC documentation (technical content) to support IND/IMPD and BLA/MAA filings. You will be accountable for informational, pre-submission and scientific advice meetings with global health authorities. The Technical Regulatory Lead must maintain a high level of professionalism, efficiency, and follow-through as the primary technical regulatory liaison for the assigned product.

You will ensure that the quality and content of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of biologics. You will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.

Additionally, you will influence and develop the long-range goals and objectives of the organization and you will support departmental business processes to document and improve best practices and work efficiencies. The decisions you make will have a significant impact on the organization and the portfolio.

The successful candidate will demonstrate effective problem solving, strong understanding of regulatory, excellent interpersonal/collaboration skills, the ability to prioritize multiple tasks and lead in a matrix team environment and have the skills to lead communications with regulatory agencies to facilitate the review and approval of submissions.

Must have a proven ability to communicate effectively in both a written and verbal format. Have a demonstrated ability to work both independently and collaboratively in a team structure, including a proven ability to work well under pressure.