Director Downstream Process Development
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Director Downstream Process Development

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

Responsible for developing robust and scalable downstream manufacturing process to support early and late phase gene therapy products in the Center for Breakthrough Medicine pipeline. Provide technical support to technology transfer, scale up, and internal/external manufacturing, as well as regulatory filings as needed. Oversee the process development scientists and associates within their team to drive innovative and novel development to meet CMB and client shared goals and milestones. The candidate will be responsible for the development of the team and ensuring training and development metrics are met.

Responsibilities

Lead downstream process development activities to optimize processes for the production of viruses, proteins, viral vectors

• Design and execute key experiments to support development goals using Quality-by-Design (QbD) principles

• Lead a team focused on optimization and development of novel methods in production and purification of gene therapy vectors

• Develop, acquire, and implement new technologies to Ring Process Development platform

• Work closely with the Platform Development and Translational teams to enable platform acceleration and scale-up

• Provide scientific leadership by coordinating teams across diverse backgrounds, spanning in vivo biology to machine learning

• Establish and oversee external project and scientific collaborators and contract research organizations

• Maintain scientific and technical expertise through familiarity with scientific literature, attending conferences, and developing relationships with thought leaders

• Hire, manage and mentor staff. Plan and assign duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.

• Work closely with an entrepreneurial, highly-collaborative, interdisciplinary team and actively contribute to creating, shaping and executing the scientific vision of the company

Qualifications

 PhD+ 5 years industry experience, MS+10 years industry experience or equivalent in bioengineering, chemical engineering, biology, virology, biochemistry or related field

• Demonstrated ability in working with highly skilled teams in a fast-paced, entrepreneurial and technical environment.

• Expertise in protein and gene therapy vector purification, process scale-up, and manufacturing

• Experience with process development and Quality by Design (QbD) methodology.

• Attention to detail, strong analytical and problem-solving skills

• Experience with developing strategic timelines and executing successful on corporate goals

• Demonstrated ability in working with highly skilled teams in a fast-paced, entrepreneurial and technical environment

• Strong management experience and success in developing a scientific team and program

Compensation: TBD

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