Senior Director, Analytical Sciences

Proclinical, in support of our client, are seeking an individual to fill the role of Senior Director, Analytical Sciences, based in Wilmington, DE. The successful candidate will possess broad knowledge and experience in analytical method development, protein structure analysis and characterization, and QC testing for biophysical and biochemical analysis proteins.

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 phase-specific 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 including deviation and OOS investigation and appropriate GMP documentation.
• Grow, develop, and lead the Biologics analytical core functional capabilities which includes resource planning, recruiting top talent, and setting up internal labs.
• Responsible for vendor selection, contract initiation and approval, technical review of quality agreements to support analytical/ QC testing.
• Support and participate in cross-functional teams including Manufacturing, Regulatory, Quality Assurance, Process Development, and Drug Product Technologies to progress the Biologics portfolio.
• 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 biotech/biopharma/biosimilar experience.
• 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.
• Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
• Knowledge of antibody drug development.
• Proficient in study design, protocol and technical report writing and review.
• Excellent written, verbal and interpersonal communication skills.

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 Hunter Tonn at (+1) 646-851-0086 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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