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Supervisor, Process Sciences

Manufacturing Supervisor
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 ManufacturingSupervisor is providing direct and detailed GMP manufacturing oversight ofmanufacturing of Drug Substance of Train 1 at Alnylam manufacturing plant. Inaddition, this position will be responsible for supervision of theManufacturing team and successful execution of the manufacturingcampaigns.
The successfulcandidate will be responsible for supervision of the GMP manufacturing team andGMP manufacture of modified oligonucleotides and siRNAs Drug Substance. Thisposition will report to a Manufacturing Team Manager
Summary of Key Responsibilities
Supervision of staff; organization and oversight of executionof manufacturing processes
Implementation and execution of manufacturing process atNorton facility by communicating job expectations; planning, monitoring, andappraising job results; coaching, counseling, and disciplining employees;initiating, coordinating, and enforcing established systems, policies, andprocedures.
Manages subordinate staff in the day-to-day job-relatedactivities.
Attain a good understanding and knowledge of themanufacturing processes, materials, equipment, and batch documentation to beable 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 costreductions; developing reporting procedures and systems; facilitatingcorrections to malfunctions within process control points;
Implements production plans by scheduling and assigningpersonnel; accomplishing work results; establishing priorities; monitoringprogress; revising schedules; resolving problems; reporting results of theprocess execution and exceptions.
Maintains quality service by establishing and enforcingAlnilam 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; answeringquestions and responding to requests.
Maintains safe and clean work environment by educating anddirecting 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 attendingeducational workshops; reviewing professional publications; establishingpersonal networks; benchmarking state-of-the-art practices; participating inprofessional societies.
Participate in creating and reviewing SOPs and batch recordsin support of the in-house non-GMP manufacture
Perform other related duties as assigned.
Qualifications
BS in Chemistry or Chemical Engineering with no less than 5 yearsof manufacturing experience in an industrial setting.
Experience in the following areas: Supervision, Coaching,Managing Processes, Process Improvement, Tracking Budget Expenses, ProductionPlanning, Controls and Instrumentation, Supporting Strategic Planning, ConflictResolution
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 techniquesinvolved in manufacture of oligonucleotides. Related hands-on experience ispreferred. 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 isable to manage a team in a highly dynamic environment with aggressivetimelines.
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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