As a member of the Manufacturing Sciences & Technology Team, the Manufacturing Specialist will be responsible for contract and project management oversight of external manufacturing partners. In addition to external facing responsibilities, this position may also provide technical support for internal manufacturing. Areas of focus include supplier management, facilitating technology transfers, change management, and supporting deviation investigations. Extensive collaboration with internal and external customers is required. Experience with mRNA production, lipid nanoparticle formulation, drug product fill finish, or ex-vivo gene therapy manufacturing is required.
- Responsible for the day-to-day oversight of drug substance and drug product manufacturing at Beam’s contract manufacturing sites.
- Coordinates manufacturing service, supply, and quality agreements with CMO’s while collaborating closely with internal partners.
- Assures alignment of external manufacturing schedules with product supply forecasts and program timelines.
- Develops and maintains detailed project plans, assesses risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
- Tracks CMO related metrics/ KPIs, and prepares presentation materials for management reviews.
- Evaluates facility and equipment design for ability to meet process and regulatory expectations.
- Ensures safe and compliant cGMP operations.
- Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
- Leads and/or assists with manufacturing deviation investigations and change controls.
- Manages tech transfer and process scale-up with input from PD and Manufacturing.
- Travels for in-person interactions with multiple contract manufacturing entities to ensure production is on track.
- Performs other related duties and ad hoc projects as required by position.
- BS in Engineering or Life Sciences with 2 years of relevant work experience or MS with minimum 0-2 years of relevant work experience, or relevant comparable background.
- Demonstrated success working independently in a high matrix environment.
- Experience with oversight of GMP drug substance, drug product formulation, or fill finish manufacturing operations; including batch release and external CMO management.
- Experience hosting GMP regulatory inspections desirable.
- Demonstrated strong understanding of cGMP and CMC regulatory requirements.
- Experience with technology transfer, scale-up and clinical development, commercial GMP lot release.
- Experience with equipment, facilities and utility systems design, startup, and qualification in a cGMP setting.
- Experience managing event investigations, Root Cause Analysis (RCA), and CAPA.
- Excellent technical report writing skills.
- Must be detail oriented with strong communication, interpersonal and problem-solving skills.