The Director of MS&T will be responsible for operational & technical leadership to ensure reliable supply of products to support early development programs, portfolio growth, and champion implementation of robust, scalable, and cost-efficient processes. This individual will establish and lead a team of technical staff that will oversee contract and project management 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, leading business reviews, and supporting investigations. Extensive collaboration with internal and external customers is required. Previous management experience with mRNA production, lipid nanoparticle formulation, drug product fill finish, or ex-vivo gene therapy manufacturing is required.
- Define the mission, vision, and strategy for MST and drive advancement of Beam’s development candidates in the manufacturing space.
- Works closely with internal stakeholders on supply forecasting and contract vendor selection.
- Responsible for establishing 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, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
- Establishes resource models, generates metrics/ KPIs, and presents materials at 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.
- Represents department to regulatory authorities when required.
- 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 a minimum 15 years of relevant work experience or a MS with a minimum of 10 years of relevant work experience or a PhD in Chemical Engineering, Bioengineering, Biochemistry, with minimum 5 years of relevant work experience.
- Demonstrated success building and leading technical teams 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 successfully leading 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.