Director/Sr. Director, Manufacturing
Scorpion Therapeutics, Durham, North Carolina, United States, 27703
Role Summary
Director / Senior Director, Manufacturing to lead Beam's internal manufacturing team across multiple modalities (mRNA, Lipid Nanoparticles, and Autologous Cell Therapy) for clinical and commercial supply. This role is part of the North Carolina Site Leadership Team and will develop and implement operational strategies to build a nimble, flexible, efficient operation and ensure safe and reliable supply. The successful candidate will have a proven track record of building high-performing teams, interfacing with multidisciplinary groups, and driving cross‑functional collaboration to deliver high‑quality products.
Responsibilities
Cultivate Beam’s culture and our values‑driven organization focused on people.
Define and implement the mission, vision, and strategy for Beam internal cGMP Manufacturing, supporting both clinical and commercial operations.
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.
Support establishment of long‑range and business continuity plans.
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions, and present materials at management reviews.
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 facility and equipment design and qualification for ability to meet process and regulatory expectations.
Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
Lead and/or assist with manufacturing deviation investigations and change controls.
Supports tech transfer and process scale‑up in partnership with Process Development and Manufacturing Science & Technology.
Must be willing to have a flexible schedule to support a multi‑shift operation that covers nights and weekends as needed.
Qualifications
BS, MS a plus, in Life Sciences or Engineering with minimum of 15 years of relevant experience.
Proven experience as a direct manager of people and as a leader in clinical and commercial cGMP manufacturing operations; experience leading cell/gene therapy manufacturing operations preferred.
Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
Strong background in drug development and regulatory requirements.
Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
Demonstrated business acumen, including long‑range planning and budget management.
Dynamic interpersonal skills and the ability to manage through influence.
Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
Results oriented with the ability to demonstrate resiliency, ownership and drive.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
Travel for in‑person interactions with cross‑functional stakeholders.
This is an on‑site position.
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Responsibilities
Cultivate Beam’s culture and our values‑driven organization focused on people.
Define and implement the mission, vision, and strategy for Beam internal cGMP Manufacturing, supporting both clinical and commercial operations.
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.
Support establishment of long‑range and business continuity plans.
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions, and present materials at management reviews.
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 facility and equipment design and qualification for ability to meet process and regulatory expectations.
Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
Lead and/or assist with manufacturing deviation investigations and change controls.
Supports tech transfer and process scale‑up in partnership with Process Development and Manufacturing Science & Technology.
Must be willing to have a flexible schedule to support a multi‑shift operation that covers nights and weekends as needed.
Qualifications
BS, MS a plus, in Life Sciences or Engineering with minimum of 15 years of relevant experience.
Proven experience as a direct manager of people and as a leader in clinical and commercial cGMP manufacturing operations; experience leading cell/gene therapy manufacturing operations preferred.
Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
Strong background in drug development and regulatory requirements.
Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
Demonstrated business acumen, including long‑range planning and budget management.
Dynamic interpersonal skills and the ability to manage through influence.
Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
Results oriented with the ability to demonstrate resiliency, ownership and drive.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
Travel for in‑person interactions with cross‑functional stakeholders.
This is an on‑site position.
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