Jennifer Brook Email & Phone Number

Providing site and corporate GMP and GLP QA support to biotech and pharmaceutical companies. Activities include, but are not limited to: auditing & vendor qualification, controlled document generation, review & approvals (batch records, SOPs, TMs, validation, stability, toxicology studies, etc.), quality system assessments, PAI preparation, training, regulatory filings, personnel interviews.1099 consultant with over 30 years industry experience.

Rtp

Implementation and management of RTP branch of TheQ, Inc. consulting firm (QA, QC/Analytical, CMC services)

Oversight of all aspects of GMP compliance for CMOs in support of late stage clinical development products. Contribute to and review regulatory submissions and amendments.

Manage the department performing review, trending and responses to product quality complaints. Develop and validate changes to Product Complaint database. Create and implement training requirements. Manage and allocate 600k budget.

Vendor management. Conduct vendor and internal site audits for GMP & GLP compliance. Management of regulatory commitment and internal audit databases. Provide auditor training. Corporate SOP writing.

Lead specification Change Control Review Board, review of CMC regulatory documents, author and review manufacturing and microbiological changes for IND annual reports, compliance representative on clinical and commercial product teams, perform audits, author and provide multi-site training on quality systems. On site QA assessment and support for integration of aquired manufacturing site.

Site QA support of late stage clinical product through commercial launch. Activities include: PAI prep, batch record review, auditing, QA trending and quarterly reports, incidents/deviations/investigations, training of department personnel in site QA activities.

Protein modification, purification and characterization for numerous clinical and pre-clinical project teams, with the goal of increasing bioefficacy of the proteins. Operation, maintenance, data analysis and method development on the following instruments: FPLC, HPLC, Maldi-TOF Mass Spectrometer, and Procise Sequencer. Managing data storage hardware and software for backup of laboratory instruments.

Design and conduct experiments to investigate the physical characteristics of biological tissue used for heart valve design. Interpret and statistically analyze experimental results. Implementation of regulatory requirements.

Development of an automated capillary electrophoresis instrument used to sequence DNA. Analyzed different running parameters of the instrument and interpreted data to support algorithm testing. Equipment maintenance, DNA sequencing reactions (Tabor-Richardson) and polyacrylamide gel preparation.

Mba, Business

Bs, Biochemistry

Activities and Societies: Research associate 1992-1995: Purification, characterization & analysis of proteins isolated from Artemia.

Bachelor Of Science - Bs, Biochemistry

Bachelor Of Science - Bs, Biochemistry

Bachelor Of Science - Bs, Biochemistry