Senior Manager, Quality (Bio Assay)

As the Senior Manager, Quality (Bio Assay), you are integrated into the Oceanside Quality team that shares responsibility for building and shaping our QC network towards the future. In this role, you will report to the QC site head, and you will work closely with the other Quality Control Heads as well as the QC Network Chapter lead and the Oceanside Quality leadership team. You will be the Bioassay primarycontact for Oceanside QC related activities including testing, troubleshooting and method transfer.

The Opportunity

• Accountable for the execution of activities within the Bioassay department including the following: Cell Based Potency, ADCC Potency, Binding Potency, CHOP ELISA, Cell Culture maintenance for the above assays.

• Collaborate with global SMEs and peers within the network to ensure robust best practices sharing for Bioassays.

• Plan, initiate, implement and oversee department activities to meet department and corporate objectives within specified timelines.

• Provide overall direction, performance management, and career development for subordinate staff within the Bioassay group.

• Implement operational, policy, and procedural directives for the Quality Control Bioassay group, including the review and approval of recommendations and analytical data.

• Lead and manage people processes - staffing, talent management, and performance management to meet strategic and operational objectives.

• Foster a strong team spirit, effective communication, and a continuous improvement mindset, being an active change agent promoting new opportunities and technologies.

• Act as a project leader, coordinate activities between divisions, provide scientific leadership, and represent the Bioassay department during regulatory inspections and decision-making processes regarding capital expenditures and new technology acquisitions.

• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

• Promotes a safety culture that supports continuous improvement in the EHS management system through active communication and functional area participation in site safety teams ensuring the safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt

Who you are

Education and Experience

• Bachelor's Degree in Biology, Chemistry, Biochemistry, Microbiology or other
  relevant Life Science discipline.

• 14 years experience including 5 years in supervisory role

• Including 9 years experience in a pharmaceutical/biotechnology lab.

Knowledge, Skills, and Abilities

• Experience supervising technical staff in a Quality Control and/or cGMP environment
  Familiarity with scientific disciplines outside of primary areas of expertise

• Demonstrate excellent project management skills including the ability to plan, prioritize and complete own work and the work of others.

• Demonstrate excellent personnel management and interpersonal skills including the ability to effectively collaborate with staff from other departments and representatives from regulatory agencies.

• Demonstrate excellent written and verbal communication skills.

• Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests.

• Ability to work independently and as a member of a team.

• Ability to invest time, as required, to expedite or complete assignments or projects. Including working non-standard hours such as evenings and weekends as necessary.

• Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.

Work Environment/Physical Demands/Safety Considerations

• Expected to be on foot for 8 to 10 hours a day.

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

• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn and no make up or jewelry can be worn when working in the clean room environment.

• When working in a clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.

• May work with hazardous materials and chemicals.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $122,500 - $227,500 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.