Senior Quality Control Associate

Location
South San Francisco, California
Posted
Sep 04, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

The primary responsibilities include lot release testing, stability testing, method transfers, method qualification/validations, analytical investigations and specification setting for drug substances and drug products.  The Senior Quality Control Associate will support oversight of Quality Control testing at contract testing labs and contract drug substance and drug product manufacturing operations to ensure projects timelines are maintained.  This includes method transfer, method validations, raw data/protocol/report review, exceptions management (Deviations, CAPAs and OOSs) and change control.  The successful candidate will oversee the stability program and support the development of corporate quality systems for laboratory controls (such as reference standards, critical reagents, etc.) and ensure compliance with regulators.

 Responsibilities:

  • Provide technical expertise and specialized knowledge in Quality Control systems for release and stability testing of clinical and commercial products (small molecule pharmaceuticals and protein biologics)
  • Responsible for oversight of the stability test program for clinical and commercial products Establishes and executes ICH stability programs for drug substances and drug products. Maintains stability testing databases and oversight on active program at the CTLs
  • Reviews/approves the qualification/validation/transfer of analytical procedures
  • Prepares/reviews specifications for starting materials, drug substances, drug products, and reference standards.
  • Review and approval of analytical methods, SOPs, test records, and CofAs
  • Authors/reviews the batch analysis, stability and reference standard sections of the regulatory submissions (CTA/ IND or NDA/BLA)
  • Supports laboratory investigations related to test failures, discrepancies and deviations
  • Supports Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate
  • Serves as SME for areas of responsibility during regulatory inspections
  • Supports corporate and third party inspection readiness activities

 Requirements:

  • A BS/MS degree in the field of chemistry, biochemistry or pharmaceutical chemistry, with 8 years of experience in the biotechnology/pharmaceutical industry
  • Experience in analytical methodologies used for analysis and characterization of small molecule pharmaceuticals, such as HPLC, GC, UV, LC-MS, FTIR and dissolution
  • Experience in bioanalytical HPLC, SDS-PAGE, CE-SDS, cIEF and other purity and impurity assays
  • Experience in managing and interacting with contract CMOs
  • Knowledge of Quality Systems and current FDA regulations and ICH guidelines
  • Experience writing analytical and stability related section of (CTA/ IND or NDA/BLA)submissions
  • Must be highly organized and have the ability to communicate effectively with internal and external organizations
  • Highly motivated team player willing to contribute to a growing biopharmaceutical company