Associate Director Product Development, Process Analytical Sciences

Company: Alnylam Pharmaceuticals, Inc.
Location: Cambridge
Posted on: June 8, 2021

Job Description:

Associate Director Product Development, Process Analytical Sciences

Overview

Alnylam 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 Responsibilities

• Lead 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 activities
• Lead the preparation of the Drug Product section of regulatory filings and effectively represent the Drug Product function in interactions with regulatory authorities
• Contribute to strategic technical discussions and present progress at internal and external scientific meetings
• Effectively 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 Affairs
• Periodic travel to manufacturing and other partner sites is required

Qualifications

• Degree 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 development
• Hands-on experience in analytical methods for characterization of drug products and processes
• Experience in filtration technology, including sterile filtration, diafiltration and ultrafiltration
• Excellent leadership, organizational and communication skills
• Demonstrated strong operational execution and problem-solving skills
• Desire 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, Inc., Cambridge , Associate Director Product Development, Process Analytical Sciences, Other , Cambridge, Massachusetts