Senior QC Analyst Late Phase

Genentech

Philadelphia, Pennsylvania

JOB DETAILS
SKILLS
Analysis Skills, Assay Development, Assays, Cell Cultures, Change Control, Chromatography, Continuous Improvement, Corporate Policies, Corrective Action, Detail Oriented, GMP (Good Manufacturing Practices), Gene Therapy, Industry Standards, Laboratory Systems, Laboratory Techniques, Legal, Maintain Compliance, Polymerase Chain Reaction (PCR), Problem Solving Skills, Quality Assurance Methodology, Quality Control, Real-time PCR (qPCR), Regulatory Compliance, Securities and Exchange Commission (SEC), Technical Writing, Validation Plan, Writing Skills
LOCATION
Philadelphia, Pennsylvania
POSTED
3 days ago

The Opportunity

  • Perform and support critical analytical testing for late-phase and commercial gene therapy programs within a primarily laboratory-based environment.

  • Execute a variety of advanced laboratory techniques, ensuring high technical competence and analytical precision.

  • Ensure strict adherence to global GMP regulations, following established protocols, test methods, and compliance standards.

  • Lead and support complex laboratory investigations, change controls, and Corrective and Preventive Actions (CAPAs).

  • Author technical protocols and comprehensive reports to support assay development, validation, and continuous improvement initiatives.

  • Collaborate closely within a dynamic quality control team dedicated to bringing innovative, life-changing therapies to patients safely.

Who You Are

  • You hold a Bachelor's Degree in a related field - Master's Degree is preferred

  • You have 3-5 years of experience in an analytical lab setting with a preference for experience in a GMP laboratory

  • You bring proven professional experience working within a regulated GMP laboratory environment.

  • You possess hands-on proficiency with core laboratory techniques, such as Cell Culture, ELISA, Activity Assays, qPCR/PCR, or SDS-PAGE.

  • You have experience in separations methods including CE-SDS, and Size Exclusion Chromatography (SEC) with familiarity with Empower and 32Karat software.

  • You have experience with or an interest in utilizing industry-standard laboratory software (e.g., SoftMax Pro, QuantStudio, Excel).

  • You possess strong technical writing skills with initial experience or exposure to assay development or validation protocols.

  • You are a detail-oriented problem solver who thrives on leading investigations and translating complex data into actionable quality improvements.

Relocation benefits are not provided.

The expected salary range for this position based on the primary location of Philadelphia, Pennsylvania is $105,000 to $195,000.  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.

About the Company

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Genentech