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.

Senior Manager, Manufacturing Technical Services will be responsible for the technical and GMP management of the drug substance, API, and Raw Material contract manufacturing organizations (CMOs) used for the supply of clinical and commercial programs. This position is responsible for partnering with CMOs to establish robust working relationships related to the manufacturing of oligonucleotides, and critical custom raw materials, to ensure uninterrupted supply of clinical and commercial product. Incumbent will foster effective cross-functional working relationships with internal and external groups which support day-to-day manufacturing operations with a focus on technical knowledge of the drug substance process. The Senior Manager will provide support for on the floor manufacturing activities, deviation, change control and CAPA championing, as well as support regulatory submissions, and strategic decision making. This position is also expected to lead, develop, and mentor a team of engineers and scientists, and think critically about ways to continuously improve the late stage raw materials program at Alnylam.

This position is expected to make efficient and effective use of resources, have a well-managed staff, and be an effective collaborator with suppliers and supporting departments as well as be able to communicate to all levels of the organization.

Key Responsibilities

• Lead a team of engineering and scientific professionals to provide high level technical support for API and Raw Material supply. Develop and foster a collaborative environment to ensure effective, constructive, relationships between internal and external partners
• Work with CMOs to deliver on all clinical and commercial drug substance and raw material supply requirements through trouble shooting and transfer of robust manufacturing processes
• Manage technical relationships with CMOs
• Ensure uninterrupted product supply while successfully working with the support of internal and external cross functional teams (QA, Validation, Supply Chain and Process Sciences)
• Identify and execute upon continuous improvement initiatives
• Participates in development and implementation of risk management strategies for the company's supply chain; including identification and implementation of Op Ex opportunities
• Directs and influences third party manufacturers to identify and implement cost savings and process improvements based on inputs from internal partners while working within the GMP & nGMP framework
• Be technically competent process expert to direct staff and CMOs with respect to decisions needed to further oligonucleotide drug substance manufacturing.

• BS in Chemical Engineering/Chemistry or related field. Graduate Degree/Studies preferred
  
  
  • 9 years (BS)
  • 6 years (MS)
  
  
• Thorough knowledge of cGXP requirements for pharmaceutical manufacturing and clinical supply required
• Experience managing Contract Manufacturing Organizations, including international vendors
• Proven ability to lead and develop teams and motivate staff
• Experience with regulatory submissions
• Experience with tech transfer, deviations, CAPA, equipment qualification, risk assessments, & root cause analysis
• Familiarity with SPC and process control
• Ability to Travel up to 20%