Senior QC Technical Manager, Direct Materials (Raw Materials)

We are seeking a proactive and experienced Senior QC Technical Manager, Direct Materials (Raw Materials) to lead and support raw material quality programs at our commercial pharmaceutical manufacturing facilities. This is a unique opportunity for a chemist or raw material expert to play a pivotal role in establishing and launching a new raw material laboratory. The successful candidate will contribute technical leadership in analytical testing, provide strategic oversight of raw material programs, and ensure the lab is set up to meet regulatory and operational requirements from day one.

This role combines deep expertise in raw material release testing, method development, and quality systems with strong project management and collaboration skills. The ideal candidate is excited about building processes from the ground up, thrives in cross-functional teams, and is committed to operational excellence.

The Opportunity

• Oversee technical and quality aspects of analytical testing, trend data, and ensure timely release of materials including excipients, components, and biological materials.

• Plans, coordinates, and executes technical transfers and other projects with local/global partners, owning key milestones.

• Lead process improvement projects and resolve complex direct material quality issues. Conduct in-depth supplier assessments of manufacturing processes and capabilities.

• Ensure technical and quality capabilities are in place to enable the testing of compendial and non-compendial methods such as FTIR, NIR, HPLC, UV/Vis, GC, wet chemistry, MS, Karl Fischer, and titration.

• Coordinate and schedule internal and contract lab testing to meet production timelines; review raw material data for accuracy and compliance.

• Provide technical guidance and oversee quality aspects of assay deviations including but not limited to: equipment malfunctions, system suitability issues, and investigations.

• Manage tech transfer, assay verification, method validation, and assay qualification initiatives.

• Effectively collaborate with global teams to implement efficient, risk-based control strategies and specifications for raw materials used in commercial manufacturing.

• Develop and implement key performance and productivity metrics for raw material testing operation.

Compliance, Quality Systems & Documentation

• Ensure adherence to current Good Manufacturing Practices (cGMP), pharmacopeial (USP/EP/JP) standards, and regulatory guidelines (FDA, ICH, EMA).

• Author and review SOPs, assay protocols, technical reports, and validation/verification documentation.

• Lead or support investigations, deviations, CAPAs, non-conformance reports, and change control related to raw materials and testing.

• Develop systems and procedures that align with internal controls and quality objectives.

Who you are

Education & Experience

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline.

• 5-7+ years of experience in pharmaceutical/biotech QC labs, including hands-on raw material testing under cGMP.

• Proven experience with analytical instrumentation and techniques, including method development, validation, and troubleshooting.

• Experience working with contract laboratories and coordinating outsourced testing is strongly preferred.

Technical Expertise

• Deep understanding of analytical instrumentation (e.g., FTIR, GC, HPLC, MS) and compendial methodologies.

• Strong grasp of pharmacopeia standards (USP, EP, JP) and global regulatory expectations.

• Proficiency in data analysis, trend evaluation, and report generation for raw material testing.

Preferred Qualifications

• Experience in the development or scaling of QC laboratories in GMP environments.

• Experience in "Train the Trainer" programs or a track record of leading QC technical training.

• Familiarity with materials handling equipment and safe lab practices.

Physical & Work Environment Requirements

• Must be able to stand, walk, and use laboratory equipment for extended periods.

• Ability to lift up to 35 lbs and wear necessary personal protective equipment (PPE).

• Work is performed in a cGMP-regulated manufacturing facility.

Travel may be up to 30% during start-up laboratory activities. No more than 10% travel expected during routine operations.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $90,100-$167,300 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.