Anne Macintyre Email & Phone Number

Attleboro, Ma, Us

Westborough, Massachusetts, United States

Westborough, Ma

Milford, Ma

Process Sciences

Cell Culture Development

Upstream Process Development

• Proficient in the development and support of clinical and commercial manufacturing mammalian cell culture processes.• Development experiences range from preclinical evaluations through post-market launch support. Responsibilities included medium optimization, inoculum train design, bioreactor studies, robustness studies, phenotypic stability studies, raw material testing, cell bank production, and manufacturing support.• Provided extensive commercial development support for TYSABRI® which achieved FDA approval in November 2004 for relapsing forms of multiple sclerosis.• Led an inter-departmental initiative focused on cell bank technology improvements. Efforts resulted in the establishment of cell banking platforms regarding process strategies, documentation requirements, cGMP support responsibilities, serum-free cell banking, and inventory management. • Routinely authored internal reports and memos as well as contributed towards the construction of solution lot records, batch records, and regulatory submission documents. Frequently presented results at meetings.• Familiar with the principles of assay development including proof of concept and assay qualification studies.• Experience with JMP statistical software and Microsoft Word, Excel, Power Point, Project, and Access.

•Conducted independent thesis research involving the identification and characterization of an insulin-like receptor in the tobacco hornworm, Manduca sexta.• Employed laboratory techniques including tissue dissection, PCR, genomic library screening, DNA cloning, gel electrophoresis, Western and Southern Blots, and electrochemiluminescence (ECL).• Additional responsibilities included animal care, supply management, and general bookkeeping.• Regularly contributed to lab meetings and journal clubs.

• Manufactured raw bulk clinical and commercial drugs in a cGMP class 10,000 clean room environment.• Operated and maintained large scale manufacturing equipment including 100L to 2000L cell culture bioreactors, protein purification columns, and micro-, viral, and ultra-filtration units.• Performed analysis of representative process samples with adherence to strict documentation requirements.