Senior Manager / Associate Director, Manufacturing

Beam Therapeutics•Durham, NC

3d•Onsite

About The Position

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Beam is looking for a highly energetic Sr Manager/Associate Director, Manufacturing to join our growing Manufacturing team. The Sr Manager/Associate Director, Manufacturing will provide manufacturing operational and technical leadership throughout commercial ramp up and expansion. The candidate will participate in hiring and development of staff for the execution of manufacturing operations. This individual will be responsible for intially managing up to 16 direct labor manufacturing personnel for GMP production and lead a significant hiring ramp based on regulatory approvals. This individual will maintain comprehensive operating plans, procedures, systems, and training plans that are consistent with company objectives. The ideal candidate will be a seasoned leader with a demonstrated track record of building and managing high performing teams. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships. Experience in cell therapy commercialization and scale out is a major plus. Preferrable for candidate to have experience in MES (electronic batch records) implementation for cell therapy.

Requirements

Bachelor’s degree preferably with a science or engineering focus and a minimum of 10 years of Manufacturing and Operations experience.
At least 2 years experience leading and developing people in a GMP setting.
Experience working cross-functionally building and maintaining strong relationships.

Nice To Haves

Autologous cell therapy experience strongly preferred.
Preferrable for candidate to have experience in MES (electronic batch records) implementation for cell therapy.

Responsibilities

Cultivate Beam’s culture and our values-driven organization focused on people.
Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing.
Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations.
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
Champion development of a learning culture that embraces innovation and continuous improvement.
Prepare and maintain departmental budget and workforce model in partnership with the Director of Manufacturing.
Support establishment of long range and business continuity plans.
Manage and support up to but not limited to multiple areas of GMP production as needed.
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions.
Build collaborative and empowered teams that put patients first.
Recruit, retain, and develop high-performing and diverse teams.
Represent department during audits and regulatory inspections.
Establish and maintain strong relationships at the site and cross-functionally.
Assures alignment of internal manufacturing schedules with product supply forecasts and program timelines.
Develops and maintains detailed manufacturing project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
Support critical regulatory inspections, electronic batch records implementation, and all commercial expansion activities.
Contributes to development and implementation of manufacturing documents (electronic batch records, procedures, and technical reports).
Assist with manufacturing deviation investigations and change controls / CAPAs.
Support facility and equipment design and qualification for ability to meet commercialization and regulatory expectations.
Ability to work onsite daily and after hours as required to support Beam clinical autologous team.