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Company

Original Job Post

Codexis, Inc. · 5 days ago

Associate Director of Quality Control

Redwood City, CA

Full-time

Hybrid

Director

$175K/yr - $220K/yr

10+ years exp

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BiotechnologyChemical

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Responsibilities

Manage, coach, and develop a high performing team for all QC GMP operations to meet the quality, integrity and efficiency standards for drug development phases.

Oversee and responsible for GMP QC product release testing and stability programs. Represent QC in cross-functional teams (Analytical Development, QA, Manufacturing, Product Management, Supply Chain departments) to meet product release timeline and manage stability programs to ensure timely testing, real time trending and generation of stability reports.

Identify, oversee and manage contract testing laboratories to meet testing needs.

Lead, approve and provide oversight for QC GMP Quality Management Systems, including but not limited to Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls. Author requisite documentation for quality events as needed.

Lead and drive activities related to GMP method validation and method transfer. Draft and develop QC related SOPs, protocols, reports, and regulatory sections. Perform data and notebook review and approval for product release as needed.

Lead QC teams to troubleshoot issues, and drive to completion opportunities for continuous improvement in QC operations.

Lead the activities to establish equipment/instrument qualification and validation program to meet the quality standards for the products at various drug development phases.

Qualification

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GMP QC ManagementFDA/EU/ICH RegulationsAnalytical ValidationInstrumentationBiocatalyst CharacterizationOligonucleotide CharacterizationEnzymatic AssaysELISAHPLCLC/MSGCKarl FischerUV-VisQPCRCE-SDSElectrophoresisQC TestingValidationLIMSELNLab Data BackupProblem-SolvingAdaptability

Required

BS or MS in Analytical Chemistry, Biochemistry or Biological Sciences or equivalent with 12+ BS degree OR 10+ for MS degree years of industrial Quality Control GMP pharmaceutical environment.

Direct QC GMP operational experience at various clinical stages of drug development.

10+ years of GMP QC management experience

Strong working knowledge of FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing.

Working knowledge of instrumentation and analytical methods for biocatalyst and oligonucleotide characterization, such as enzymatic assays, ELISA, HPLC, LC/MS, GC, Karl Fischer, UV-Vis, qPCR, CE-SDS and electrophoresis.

Preferred

Develop and build QC testing laboratory from the ground up.

Validation experience with Enterprise Laboratory Information Management System (LIMS), Electronic Lab Notebook system (ELN), or enterprise laboratory data backup system.

Ability to assess situations within broadly defined practices and procedures to determine appropriate actions.

Benefits

Medical, Dental and Vision Insurance

Basic Life, AD&D, Short- and Long-Term Disability Insurance

401k with Company Match up to 4%

Company Equity

Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time

Annual Lifestyle Account for reimbursement of fitness programs, equipment and more

Employee Stock Purchase Program (ESPP)

Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)

Student Debt Program (Company Contribution to Loans)

Mental Health Wellness Program

Subsidized onsite lunch program

Onsite Gym Facilities

Paid Parental Leave

Company

Codexis, Inc.

Glassdoor

3.6

Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins.

Founded in 2002

Redwood City, California, USA

51-200 employees

http://www.codexis.com

H1B Sponsorship

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