Supervisor, Process Sciences
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 Supervisor, Process Sciences is providing direct and detailed GMP manufacturing oversight of manufacturing of Drug Substance of Train 1 at Alnylam manufacturing plant. In addition, this position will be responsible for supervision of the Manufacturing team and successful execution of the manufacturing campaigns.
The successful candidate will be responsible for supervision of the GMP manufacturing team and GMP manufacture of modified oligonucleotides and siRNAs Drug Substance. This position will report to a Manufacturing Team Manager
Summary of Key Responsibilities
Supervision of staff; organization and oversight of execution of manufacturing processes
Implementation and execution of manufacturing process at Norton facility by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing established systems, policies, and procedures.
Manages subordinate staff in the day-to-day job-related activities.
Attain a good understanding and knowledge of the manufacturing processes, materials, equipment, and batch documentation to be able to quickly assess issues and propose solutions to encountered challenges.
Maintains work flow by monitoring steps of the process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; implementing cost reductions; developing reporting procedures and systems; facilitating corrections to malfunctions within process control points;
Implements production plans by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results of the process execution and exceptions.
Maintains quality service by establishing and enforcing Alnilam standards.
Ensures operation of equipment by calling for repairs; evaluating new equipment and techniques and following maintenance schedules.
Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data; answering questions and responding to requests.
Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
Resolves personnel problems by investigating issues; identifying solutions; recommending action.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Participate in creating and reviewing SOPs and batch records in support of the in-house non-GMP manufacture
Perform other related duties as assigned.
BS in Chemistry or Chemical Engineering with no less than 5 years of manufacturing experience in an industrial setting.
Experience in the following areas: Supervision, Coaching, Managing Processes, Process Improvement, Tracking Budget Expenses, Production Planning, Controls and Instrumentation, Supporting Strategic Planning, Conflict Resolution
In-depth understanding of GMP manufacturing and supply chain, and general awareness of US and international regulations and standards
Good understanding of analytical and manufacturing techniques involved in manufacture of oligonucleotides. Related hands-on experience is preferred. Working knowledge of phosphonamidite chemistry, chromatography, ultrafiltration etc. is a plus.
Effective communication skills are a must for this position. The successful candidate must be a responsible and proactive individual who is able to manage a team in a highly dynamic environment with aggressive timelines.
Preferred computer skills include: MS Office applications, process modeling/simulation programs, statistical experimental design and data interpretation
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.