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Manager, Process Sciences

Overview 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.  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 Manager, Process Sciences  is responsible for providing direct and detailed GMP manufacturing oversight of Train 1 at Alnylam manufacturing plant. This position will be involved in management of the Manufacturing facility and manufacturing teams as well as successful execution of the DS manufacturing campaigns.  The successful candidate will be a part of the GMP Manufacturing Group at Alnylam's Manufacturing Facility, responsible for the management of GMP manufacturing team executing GMP manufacture of modified oligonucleotides and siRNAs Drug Substance. This position will report to a unit/department head.   Summary of Key Responsibilities Plans, schedules, and manages one or more manufacturing campaigns. Assists with planning and directing of an efficient layout of equipment and flow of materials. Ensures manufacturing performance, volume and quality goals are met by utilizing efficient methods and maintaining appropriate staffing levels. Ensures that project/department milestones/goals are met and adhering to approved budgets. Support all phases of the DS manufacturing project life cycle including: technology transfer, clinical production campaign, deviation evaluation and investigation, batch disposition, and campaign conclusion and summary. Maintains staff by participating in recruiting, selecting, orienting, and training employees; identifying and developing personal growth opportunities. Creates and 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 Alnylam standards. Responsible for operation of manufacturing equipment. Attain in-depth 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. Drive GMP Compliance and evaluate all aspects of ongoing production and understand when to intervene and escalate more significant issues for resolution. Partner with Quality functions (internal QA/QC,) to ensure timely review of new and executed batch production records, deviations, investigations, CAPAs, and may own and drive Change Controls as needed. Communicate routine production manufacturing status to department head and assist as necessary with process data retrieval, processing, analysis, through written, verbal, and presentation at various meeting forums.   Qualifications BS in a scientific field of study with minimum 8+ years of relevant experience working in GMP Manufacturing/Contract Manufacturing in the Pharmaceutical/ biotech industry as an individual contributor and 3+ years of supervisory experience Ability to summarize executed manufacturing campaigns into presentations and reports In-depth understanding of GMP manufacturing and supply chain, and general awareness of US and international regulations and standards Proven ability to work independently, leadership aptitude and good people skills with the desire and ability to work in a fast-paced, start-up environment Strong collaboration and team-building, communication, and organizational skills required Experience working with third party contractors and vendors Experience with trouble-shooting and providing solutions to complex technical and logistical issues Excellent written and verbal communication skills 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.   Job Number:  TOQA20191020
Salary Range: NA
Minimum Qualification
8 - 10 years

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