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Manager, Process Sciences

Manager, Process Sciences
Overview
Alnylam was founded in 2002 on arevolutionary vision and bold mission which remain firmly in place today. Weare leading the translation of RNA interference (RNAi) into a new class ofinnovative medicines with the potential to transform the lives of people withrare genetic, cardio-metabolic, hepatic infectious, and central nervous systemdiseases 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 thepolyneuropathy of hereditary transthyretin-mediated amyloidosis in adults andby the European Medicines Agency in the EU for the treatment of hATTRamyloidosis 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 beenrecognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017and 2018- four years in a row!
The Manager, Process Sciences is responsible for providing direct anddetailed GMP manufacturing oversight ofTrain 1 at Alnylam manufacturing plant. Thisposition will be involved in management of the Manufacturing facility andmanufacturing teams as well as successful execution of the DS manufacturingcampaigns. The successful candidate willbe a part of the GMP Manufacturing Group at Alnylam's Manufacturing Facility,responsible for the management of GMP manufacturing team executing GMPmanufacture of modified oligonucleotides and siRNAs Drug Substance. Thisposition will report to a unit/department head.
Summary of Key Responsibilities
Plans, schedules, and manages one or more manufacturingcampaigns.
Assists with planning and directing of an efficient layout ofequipment and flow of materials.
Ensures manufacturing performance, volume and quality goalsare met by utilizing efficient methods and maintaining appropriate staffinglevels.
Ensures that project/department milestones/goals are met andadhering to approved budgets.
Support all phases of the DS manufacturing project life cycleincluding: technology transfer, clinical production campaign, deviationevaluation and investigation, batch disposition, and campaign conclusion andsummary.
Maintains staff by participating in recruiting, selecting,orienting, and training employees; identifying and developing personal growthopportunities.
Creates and implements production plans by scheduling andassigning personnel; accomplishing work results; establishing priorities;monitoring progress; revising schedules; resolving problems; reporting resultsof the process execution and exceptions.
Maintains quality service by establishing and enforcingAlnylam standards.
Responsible for operation of manufacturing equipment.
Attain in-depth understanding and knowledge of themanufacturing processes, materials, equipment, and batch documentation to beable to quickly assess issues and propose solutions to encountered challenges.
Drive GMP Compliance and evaluate all aspects of ongoingproduction and understand when to intervene and escalate more significantissues for resolution.
Partner with Quality functions (internal QA/QC,) to ensuretimely 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 todepartment head and assist as necessary with process data retrieval,processing, analysis, through written, verbal, and presentation at variousmeeting forums.
Qualifications
BS in a scientific field of study with minimum 8 years ofrelevant experience working in GMP Manufacturing/Contract Manufacturing in thePharmaceutical/ biotech industry as an individual contributor and 3 years ofsupervisory experience
Ability to summarize executed manufacturing campaigns intopresentations 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 andgood people skills with the desire and ability to work in a fast-paced,start-up environment
Strong collaboration and team-building, communication, andorganizational skills required
Experience working with third party contractors and vendors
Experience with trouble-shooting and providing solutions tocomplex 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 datainterpretation
Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.

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