Senior Engineer Manufacturing Technical Services
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row!
The Senior Engineer, position in the Manufacturing Technical Services group will be responsible for the technical and GMP support for contract manufacturing organizations (CMOs) used for the supply of Drug Substance. This position is responsible for partnering with CMOs to establish robust technical working relationships, implement process improvements, and ensure process consistency. The candidate should have a strong background in GMP Manufacturing, Engineering Principals, and leading tech transfers and risk assessments. 15-20% Travel is required.
The position will also be responsible for leading tech transfer, owning process improvement initiatives, Data Monitoring, and deviation investigation/closure. The candidate will be responsible for fostering effective cross-functional working relationships with internal and external groups to support technology/process transfer, day-to-day manufacturing operations with a focus on technical process knowledge and act as the lead for technical process ownership in resolving tech transfer related issues, CAPA and deviation resolution, and change control scoping, as well as support regulatory submissions and risk assessments.
Summary of Key Responsibilities
Work in a matrixed environment of engineering and scientific professionals to provide high level technical support for chemical synthesis processes.
Develop and foster a collaborative environment to ensure effective, constructive relationships between internal and external partners.
Through application of scientific and engineering principles, become a technically competent process expert to support CMOs with respect to decisions making to ensure continued supply and continuous improvement.
Work with CMOs to deliver on time technology transfer, process ownership, and trouble-shooting of chemically synthesized raw materials.
Drive cGMP compliance in manufacturing, and identify process improvements opportunities
Act as key technical contact for CMOs, including, but not limited to, providing PIP support, batch record review, technology transfer and validation support.
Support deviation investigations and continued process improvement through statistical analysis of manufacturing data and thorough understanding of fundamental unit operation principles.
Ensure uninterrupted product supply from third party manufacturers while successfully working with the support of internal and external cross functional teams (QA, Validation, Supply Chain and Process Sciences).
Works with third party manufacturers to identify and implement cost savings and process improvements based on inputs from internal partners while working within the GMP framework.
Previous experience with at least of the following isdesired:
Oligonucleotide, or small moleculeproduction
Chemical Synthesis processes
Degree in Chemical Engineering, Biotechnology, or similar:
6-9 years' experience (BS) or 5 years' experience (MS) or 0 - 3 years' experience (Ph.D.)
Experience with chemical synthesis, peptide production, or solid phase synthesis
Knowledge of cGXP.
Experience working with Contract Manufacturing Organizations, including international vendors.
Read/Write/Speak German is a plus
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.