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Sr. Manager/Associate Director

  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: US$160000 - US$190000 per year
  • Job reference: 266971/001_1550868580
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 22/02/2019

Biologics Analytical Development

A leading innovative Biotech company is looking to enhance their Biologic Analytical Development team. This Biotech is expanding their Biologics team and is seeking a strong leader to help guide the way to commercializing their phase 2 drug candidate.

As an Sr. Manager/Associate Director of Biologics Analytical R&D you will be an essential part of the company's agenda. You will be leading a team of driven scientists to carry out innovative therapeutics onto the market.

  • Associate Director | Biologics Analytical R&D
  • San Francisco Bay Area | California
  • $150,000 - $190,000 + excellent bonus + excellent benefits

Duties and Responsibilities:

  • Work collaboratively with cross functional teams, ex. Regulatory, Commercial, and Quality
  • Oversee and collaborate with outside vendors such as CROs, CMOs, and CTLs
  • Ensure protocols follow company policies, SOPs , FDA and other applicable guidelines.
  • Manage/coordinate/drive efforts of staff in conjunction with approved quotes and plant scheduling
  • Strong communication, organization, and multitasking skills are needed to lead
  • Ensure adherence to agreed-upon deadlines; timely invoicing of work.
  • Authors and/or provides oversight of CMC sections for IND and BLA regulatory submissions


  • PhD or MS in Biochemistry (or closely related discipline) with 5+ years of demonstrated success in leading teams and managing projects7+ years relevant experience in a cGMP-compliant pharmaceutical laboratory environment.
  • Experience with sterile biologics drug analyses including HPLC (SEC, IEX, RP), CE, icIEF, CZE, SDS-PAGE, peptide mapping, cell-based bioassay and other compendial methods
  • Experience across all phases of biologic drug development, with significant late stage development is a plus and preferred
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