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Manager, Manufacturing OperationsAlnylam Pharmaceuticals • Norton, Ohio, United States
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Manager, Manufacturing Operations

Alnylam Pharmaceuticals
  • US
    Norton, Ohio, United States
  • US
    Norton, Ohio, United States
Jetzt Bewerben

Über

Manager, Manufacturing Operations

The Manager, Manufacturing Operations is an integral part of the Norton Internal Manufacturing team. This role will initially be involved in the start-up of Norton's new commercial Drug Substance manufacturing train, including support for equipment commissioning & qualification, oligonucleotide technology transfer, successful execution of Drug Substance PPQ batches all the way through commercial production and launch. The successful candidate will build and manage multiple shifts for commercial GMP manufacturing in the new train. This position is an on site role in Norton that will report to the Associate Director of Manufacturing Lead End User.

Key Responsibilities:

  • Plans, schedules, and manages deliverables for Train 2 operational readiness and PPQ execution, including development, ownership, and approval of manufacturing documentation (SOP's and batch records)
  • Supports commissioning and qualification testing of new equipment, as needed
  • Assists with planning and directing an efficient layout of equipment and flow of materials
  • Ensures manufacturing schedule adherence
  • Provides coaching, feedback, and guidance for direct and indirect reports
  • Provides guidance to direct and indirect reports regarding departmental goals
  • Ensures accountability for goal execution
  • Champions a safety mindset and approach
  • Maintains staff by participating in recruiting, selecting, and orienting new hires, including development and delivery of training content
  • Identifies personal growth opportunities for reports, and provides guidance on development plans to achieve those opportunities
  • Models a continuous improvement approach by identifying issues, taking ownership, and driving solutions
  • Fosters an open culture by providing support and feedback during regular Gemba walks
  • Drives GMP compliance and understands when to intervene and escalate more significant issues for resolution
  • Partners with Quality functions (internal QA/QC,) to ensure timely review of new and executed batch production records, SOPs, deviations, investigations, CAPAs, and may own and drive change controls as needed
  • Participates in regulatory agency audits / inspections and owns associated CAPA
  • Communicates routine production manufacturing status to department head and assists as necessary with process data retrieval, processing, analysis, and presentation at various meeting forums
  • Provides off-shift on-call support for issues that require escalation on a rotating schedule
  • Collaborate with Engineering, Facilities, EHS, Supply Chain, Quality Assurance, Quality Control, Validation, and others to support above responsibilities

Qualifications:

  • B.S. in scientific or engineering field preferred
  • Minimum 7+ years of relevant experience hiring and building a manufacturing team and working in GMP Manufacturing/Contract Manufacturing commercial plant in the Pharmaceutical/biotech industry with 4+ years of supervisory experience
  • In-depth understanding of commercial GMP manufacturing, continuous improvement, and cGMP regulations. Broad knowledge of US and international regulations and standards (FDA, EMA, ICH)
  • Exposure to government inspections (FDA, EMEA, etc.) for new facility approval or routine surveillance required
  • 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
  • Hands-on experience with plant commissioning and startup, including troubleshooting and providing solutions to complex technical and logistical issues is required
  • Excellent written and verbal communication skills
  • Requires proficiency in MS Office applications. Proficiency with SAP, PI Historian, and LIMS preferred
  • Prior experience with MES/eBR strongly preferred

U.S. Pay Range $117,300.00 - $158,700.00

  • Norton, Ohio, United States

Sprachkenntnisse

  • English
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