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 two 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 1,400 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 five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine’s #1 Top Employer in 2019.
Summary of Key Responsibilities
- Manufacturing technology transfer - support due diligence, process scale-up, optimization, and technology transfer activities associated with enabling new drug product manufacturing CMOs
- Lead technical strategy decisions and subsequently author global regulatory documents associated with the technology transfer and qualification of drug product processes to CMOs for late-stage assets.
- Establish robust unit operations and probe process design spaces to define process control strategies that facilitate the commercial scale manufacture of siRNA drug products in several therapeutic categories.
- Late stage clinical and commercial production support - enable cross-functional initiatives involving resources from across the organization to:
- Support ongoing Drug Product late stage clinical and commercial manufacturing activities
- Resolve complex commercial manufacturing issues being mindful of Supply, Quality, and Regulatory constraints
- Provide process knowledge and understanding to enable on the floor manufacturing activities, assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to drug product.
- Establish routine process data trending activities and preparation of quarterly management review presentations.
- Identify and implement continuous process improvement activities, as needed; the successful candidate will have a solid understanding of related regulatory and business impacts in order to define and implement effective strategies for implementing post-approval changes
- Process validation and new product launch – Support development of process validation strategies and statistical product sampling plans that provide the appropriate data and demonstration of process control to meet GMP requirements.
- Degreed in an engineering discipline: Bachelors and 9 years, Masters and 6 years, or Doctorate and 3 years of relevant process development/engineering experience
- Previous experience in developing and scaling drug product formulation and fill finish processes, including authoring of associated regulatory filings. Experience with lipid nanoparticle formulations, tangential and normal flow filtration technologies, and the scaling of mixing operations is preferred.
- Demonstrated ability in providing leadership to cross-functional teams supporting technology transfer and scale-up of clinical and commercial manufacturing and late phase drug product clinical development.
- Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach
- Proficiency with Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis. Experience with mathematical modeling and optimization software (like Matlab, JMP, etc.) is a plus
- Must be detail oriented, be able to recognize subtle trends in data, good problem-solving abilities, and possess an ability to grasp the big picture
- Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience
- Travel to domestic and international contract manufacturing sites required (per guidance regarding Covid)