Title: ASSOCIATE DIRECTOR COMMERCIAL SUPPORT
Location: NA-US-MA-Devens
Job Number:_1204255
The Associate Director of Commercial Support Analytical Development and Testing (ADT) within Global Manufacturing Sciences & Technology serves as the leader of a team focusing on technical support for quality control laboratories around the world, assessment of method performance in the QC labs, support of the manufacturing sciences and technology (MS&T) organization, life cycle management of specifications (methods and acceptance criteria), and responses to health authority questions on commercial products. This position will be located at BMS Devens, Massachusetts site but will manage staff in Syracuse, NY as well. The commercial support function will work closely with MS&T, Quality, Global Supply Chain, and Global Regulatory Sciences to ensure the continued supply of drug product to the patients. The team will collaborate with ADT analytical project team leads (APTLs) to define commercial specifications for drug substance and drug product. The team will provide life-cycle management of analytical control strategy as well as analytical methodology modifications, and performance The group consists of technical experts, as well as, matrix team analytical leaders to manage technology transfer, critical reagents and reference standards, answer health authority questions. The scope of laboratory studies will include MS&T support, critical reagent qualifications, investigations, method redevelopment, method revalidations, and technology transfers to ROW. The group will also be required to perform testing to support commercial-phase process optimization/development efforts. The leader will drive effective partnership with peers in Analytical Development and Testing, Manufacturing Sciences and Technology, Process Development, Manufacturing Operations, Global Supply Chain, Quality, and Global Regulatory Sciences. Strong collaborative skills are essential, as well as broad technical expertise. DUTIES & RESPONSIBILITIES: Essential Duties and Responsibilities include, but are not limited to, the following: Ø Lead Global Biologics Analytical technical transfer and validation projects for commercial and clinical products to support world-wide filings and post-marketing commitments (PMC/FUM). Additionally, conduct technical transfers for within country testing to support the commercialization of BMS products. Ø Provide support and/or documentation preparation of training, protocols, reagent shipments and final reports and deviation investigatio
Qualifications:
. A PhD, MS, or BS, in Biological Sciences, Chemistry, or related disciplines with at least 8, 12, or 16 years of industrial experiences in relevant fields, respectively . A strong track record of leading and managing an analytical team in support of biologics development or commercial support . Broad expertise and experiences in biophysical and biological analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product . Strong communication and leadership skills in a highly interactive environment . Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners . Comprehensive knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting BLA filings.
Job: Process Development
