Associate Director Product Development, Process Analytical Sciences
Company: Alnylam Pharmaceuticals
Location: Somerville
Posted on: January 12, 2021
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Job Description:
Job Description - Associate Director Product Development,
Process Analytical Sciences (200009)Job Description Associate
Director Product Development, Process Analytical Sciences(Job
Number: 200009)Description Associate Director Product Development,
Process Analytical SciencesOverviewAlnylam is the world---s leading
RNA interference (RNAi) company. Founded in 2002, Alnylam was built
upon a bold vision of turning scientific possibility into reality
by harnessing the power of RNAi for human health as an innovative
new class of medicines. We are a growing biopharmaceutical company
with three approved medicines and a robust pipeline of
investigational medicines focused in four strategic therapeutic
areas: genetic medicines, cardio-metabolic diseases, infectious
diseases, and central nervous system (CNS) and ocular diseases,
including several in late-stage development. Headquartered in
Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries
and is rapidly growing globally, with additional offices in Norton,
Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands,
and Tokyo, Japan. Alnylam is proud to have been recognized as one
of The Boston Globe---s Top Places to Work six years in a row
(2015-2020), a Great Place to Work in the U.K. and Switzerland two
years in a row (2019-2020) and a Science Magazine---s Top Employer
two years in a row (2019-2020). Please visit www.alnylam.com for
more information.The successful candidate will be responsible for
process development, formulation, scale up, and process
characterization of RNAi products. The candidate will work closely
with cross-functional teams and contract manufacturing
organizations on drug product development, characterization,
process transfer and oversight of manufacturing processes.Summary
of Key ResponsibilitiesLead drug product and process development,
optimization, scale-up, characterization and pre-validation Author
and review technical protocols and reports in support of late phase
manufacture and process characterization activitiesLead the
preparation of the Drug Product section of regulatory filings and
effectively represent the Drug Product function in interactions
with regulatory authoritiesContribute to strategic technical
discussions and present progress at internal and external
scientific meetingsEffectively represent Drug Product development
on cross-functional teams including internal program teams and
externally with contract manufacturing and/or corporate partners
Effectively integrate Drug Product activities with other CMC
functions, including Drug Substance Development & Manufacturing,
Analytical Development, Quality Assurance, and Regulatory
AffairsPeriodic travel to manufacturing and other partner sites is
requiredQualificationsDegree in chemistry, chemical engineering,
biochemical engineering, or pharmaceutical sciences. Ph.D. with 9
years of hands-on formulation, product characterization and process
development and characterization experience across multiple
development projects including process transfer and management of
contract manufacturing Master---s degree with 12 years of hands-on
formulation, product characterization and process development and
characterization experience across multiple development projects
including process transfer and management of contract manufacturing
Experience working in close collaboration with technical,
regulatory, quality, clinical, project management, legal, finance,
and supply chain functions, preferably in a cGMP operational
environment. Experience in leading and managing process transfer,
outsourced development and cGMP contract manufacturing Experience
in preparing and defending regulatory documents including briefing
documents for regulatory meetings, INDs, and NDAs In-depth
understanding and hands-on experience in parenteral drug product
formulation and process developmentHands-on experience in
analytical methods for characterization of drug products and
processesExperience in filtration technology, including sterile
filtration, diafiltration and ultrafiltrationExcellent leadership,
organizational and communication skillsDemonstrated strong
operational execution and problem-solving skillsDesire to work in a
fast-paced, deadline-driven environment Alnylam Pharmaceuticals is
an EEO employer committed to an exciting, diverse, and enriching
work environment.
Keywords: Alnylam Pharmaceuticals, Somerville , Associate Director Product Development, Process Analytical Sciences, Executive , Somerville, Massachusetts
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