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Lab Operations Manager

San Diego Metro Area, CA

Post Date: 11/29/2017 Job ID: JN -112017-20485 Job Type: Bioanalytical - Scientific
  • Bachelor s/Master s degree in molecular biology, chemistry, or similar discipline and 5 to 10 years of experience working with biologics/biopharmaceuticals, or Ph.D. and 5+ years experience
  • A minimum of 3 to 5 years in a supervisory role in a GMP biopharmaceutical environment including comprehensive knowledge of analytical requirements for biopharmaceutical development and commercialization of Vaccines
  • Oversight of external Analytical Development activities .
  • Manage CMO/CRO analytics activities to advance preclinical/clinical stage novel vaccines through development, regulatory submission and approval.
  • Direct method development, transfer and validation activities, as well as testing of GMP materials.
  • Assure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards.
  • Vaccine projects will include a broad range of methods for characterization and product testing requiring strong competencies in chemical and physical techniques applied to in-process materials, drug substance and drug product. The candidate must be able to effectively communicate results and issues to peers, management and customers, internal and external (CRO/CMO), with excellent professional standards. The candidate may also be called upon to support internal Analytical Development activities.

    Responsibilities:
  • Management of CMO/CRO analytics
  • Large molecule characterization by various techniques, including biochemical/biophysical, chromatographic, spectroscopic/spectrometric methods.
  • Management of development, qualification, validation, and transfer of analytical test methods for testing in process materials, drug substance, and drug product
  • Manage contract service providers engaged in method development, characterization, and testing activities
  • Author and review protocols, reports, test methods, and SOPs
  • Conduct and document investigations following SOPs and company requirements
  • Maintain accurate and complete laboratory notebooks and records following GMP and good documentation practices
  • Generate analytical data and reports as well as CMC sections of INDs, NDAs and other regulatory filings

  • Qualification Requirements:
  • Bachelor s/Master s degree in molecular biology, chemistry, or similar discipline and 5 to 10 years of experience working with biologics/biopharmaceuticals, or Ph.D. and 5+ years experience
  • A minimum of 3 to 5 years in a supervisory role in a GMP biopharmaceutical environment including comprehensive knowledge of analytical requirements for biopharmaceutical development and commercialization
  • Experience in analytics of nucleic acid therapeutics, biopharmaceuticals, or large molecule characterization and testing from early through late stage development
  • Strong leadership experience
  • Good understanding of regulatory requirements, including ICH, USP/EP, FDA/EMA
  • Ability to work independently and manage projects in a timely manner
  • Strong interpersonal skills with an eagerness to support colleagues in Analytical Development and internal CMC and Quality teams
  • Excellent verbal and written communication skills
  • Regular international travel expected

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