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Director, Analytical Operations

Job Title: Director, Analytical Operations
Employer Name: Ashton Tweed
Web Site: http://www.ashtontweed.com
Contact Name: Colleen Lucchesi
Contact Email: CLucchesi@ashtontweed.com
Business Type: Other
Job Type: Sales/Marketing Manager/Director
Job Country: US
Job Location: Philadelphia suburb

Background:

•Ph.D. with at least 6 years experience in protein drug process development
•Professional experience pertaining to analytical/bio-analytical/microbiological methodologies in biotechnology/pharmaceutical industry (>10 years), with a track record for successful submissions and product launch.

Duties:

•Technical leadership in the Analytical Operations (includes Analytical Development and Quality Control groups) at Neose.
•Manage personnel at PhD, Masters and Bachelors level of education, while motivating and mentoring professional growth.
•Support NE-180 and emerging programs with analytical chemistry, immunochemistry, bio-assay, microbiology and contract analysis activities.
•Assembles production, release and stability data to support regulatory agency submissions/responses.
•Responsible for the review of data (in-process, release and stability) reports for accuracy in data and appropriate conclusions.
•Leads investigations on OOS/OOT data for preliminary internal discussions on compound performance.
•Coordinate contract and internal analytical activities for drug candidates moving into non-clinical and clinical trials.
•Coordinate the assembly of drug compound formulation and analysis data to support GXP studies to be conducted.
•Coordinate the review of analytical study reports for accuracy in data and appropriate conclusions.
•Coordinate the preparation and review of regulatory submission documents that are applicable to analytical (CMC and Pre-clinical) methodologies.
•Assures compliance to GMP regulations for personnel, testing and documentation where ever applicable.
•Facilitate timely information flow between members, project leaders, and senior management.

Qualifications:

•Specifically demonstrates experience in testing of therapeutic proteins (for US and EU). Detailing knowledge in bioassays used for potency determinations.
•Comprehensive knowledge of FDA regulations as they pertain to the development and manufacture of biotechnology/pharmaceutical products/processes (reagents, drug substances and drug products).
•Ability to provide analytical support to multiple projects simultaneously.
•Ability to manage employees utilizing clearly detailed objectives.
•Ability to use Microsoft Word, Excel, Microsoft Project applications.