Senior Director, Analytical Sciences

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Delaware
Posting date: 09 Apr 2019
SC.MT.22027_1554815232

At ProClinical, we are seeking an individual to fill the role of Senior Director of Analytical Sciences, based in Delaware.

Responsibilities

  • Develop strategy to deliver an acceptable and product specific analytical package to support clinical studies from Phase 1 to BLA.
  • Review and approve regulatory filing documents and responses from global regulatory agencies.
  • Oversee standard release assay panel development for drug substance and drug product.
  • Lead clinical product characterization and comparability studies required for regulatory filing.
  • Develop fit-to-phase plans for method validation and transfer.
  • Write, review and approve analytical and stability sections for regulatory filing.
  • Manage the full scope of QC testing conducted externally at contracted sites related to batch release and stability testing.
  • Grow, develop, and lead the Biologics analytical core capabilities.
  • Responsible for vendor selection, contract initiation and approval, technical review of quality agreements to support analytical/QC testing.
  • Participate in due diligence and provide feedback on the analytical data package.

Skills And Qualifications

  • PhD in biochemistry, biochemical engineering, chemistry or equivalent and 15+ years of experience in biotechnology/biopharmaceutical/biosimilars industry.
  • Experience with comparability or similarity of biologics at early and late stage.
  • Experience with GMP as it applies to analytical testing and investigation of OOS.
  • Proficient in study design, protocol and technical report writing and review.
  • Excellent oral and written communication skills.
  • Knowledge in antibody drug development.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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