Director / Senior Director, Biologics Analytical Science

Proclinical is seeking a Director / Senior Director, Biologics Analytical Science for a global biopharmaceutical company located in Gaithersburg, MD.

You will be responsible for leading a group of scientists for analytical development of multiple biopharmaceutical drug candidates from clinical development through registration.

Job Responsibilities:

• Represent Analytical Sciences and Biopharmaceutical Development in cross-organizational governance and committees to drive and steer technical and business strategies and processes.
• Lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies.
• Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
• Lead cross-functional team to develop business processes and guidelines for coordinated early and late stage analytical development activities in support of biologics commercialization, including post-market life cycle management.
• Advance scientific and regulatory approaches via active participation and leadership across industry groups and conferences.

Skills and Requirements:

• PhD in chemistry, biochemistry or related field with 10+ years of experience in the pharmaceutical industry.
• Significant and established experience in late-stage product characterization, regulatory filing, and response to agency questions.
• Strong knowledge of HPLC, capillary electrophoresis (cIEF, CE-SDS), and mass spectrometry with respect to biologics physiochemical analysis
• Experience leading/developing staff members, including both direct reports and skip-level staff
• Demonstrated scientific leader with vision in establishing analytical capabilities to support novel modalities
• Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, as well as steering cross-organizational alignment within and outside of biologics CMC development.
• Solid understanding of innovative physicochemical characterization technologies.
• Team oriented and able to lead multiple projects cross various development stages.
• Experience interacting with process, formulation, bioassay and lot release/stability functions to ensure strong cross functional collaborations and coordinated process and product development.
• Experience working with business partners across global development and manufacturing network
• Good understanding of quality systems and experience with successful internal and regulatory audits/inspections.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at +(1) 857-362-9542 or m.robinson@proclinical.com.

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

Proclinical Staffing is an equal opportunity employer.

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