Director / Senior Director, Biologics Analytical Science job in Gaithersburg, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Analytical Chemistry, Biological Sciences

Location: United States

This vacancy has now expired. Please see similar roles below...

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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INDSCIC

Salary

Highly Competitive Salary

Location:

Wrexham, Wales

Proclinical is seeking a Senior Principal Scientist to lead strategic projects in biomanufacturing processes, focusing on API/Drug substance processing.