Clark Davis Associates
Director, Process Strategy and Development
Clark Davis Associates, Raleigh, North Carolina, United States
Director, Process Strategy and Development
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Director, Process Strategy and Development (Onsite 5 days)
We are partnered with a biotech company in Winston Salem area and are seeking a Director, Process Strategy and Development focused on advanced stage cell therapy (Phase III to commercialization).
As Director, you’ll be at the forefront of shaping scientific strategy and optimizing the manufacturing process, ensuring that it meets the highest standards for efficiency, scalability, and compliance.
You shall collaborate closely with cross-functional teams to define process strategies, identify crucial parameters, and oversee technical transfers and process validations. Additionally, you are responsible for preparing regulatory documents and guiding the team through key milestones. You play a key role in fostering strong partnerships with stakeholders and clients, ensuring smooth technology transfers and addressing the evolving needs of the manufacturing process.
Qualifications:
PhD in Chemical Engineering, Biotechnology, Molecular Biology, Biochemistry or a related field.
Minimum of 10-14 years of experience in cell based therapeutics and bioprocess development.
At least 9 years of leadership experience in the biopharmaceutical industry.
Proven expertise in cell culture and cell therapy manufacturing, with a strong background in bioprocess modeling, process control systems, data analysis, and automation. Skilled in process FMEA, Quality by Design (QbD), Design of Experiments (DoE), and statistical analysis tools such as JMP.
Deep understanding of analytical methods to support process development.
Prior experience with global regulatory filings, IND and BLA submissions for cell therapy development.
Responsibilities:
Lead process optimization efforts to enhance productivity, improve yield, and ensure consistent product quality. Introduce cutting-edge manufacturing techniques to drive efficiency and innovation.
Oversee the execution of process validation and process qualification to ensure the process complies with regulatory standards and quality expectations. Design and implement control strategies for critical process parameters (CPPs) to maintain optimal performance and ensure product quality.
Oversee the creation of technical documentation for regulatory submissions (such as INDs, BLAs, etc.), ensuring full compliance with regulatory standards and that process development data aligns with the requirements for regulatory filings.
Create and execute risk mitigation plans to proactively identify and resolve potential issues. Lead technology transfer activities between development and manufacturing.
Form and guide a top-tier team of scientists, engineers, and technical specialists focused on process development. Promote strong collaboration between process development, manufacturing, quality, regulatory, and clinical teams to ensure smooth and efficient execution.
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Get AI-powered advice on this job and more exclusive features.
Director, Process Strategy and Development (Onsite 5 days)
We are partnered with a biotech company in Winston Salem area and are seeking a Director, Process Strategy and Development focused on advanced stage cell therapy (Phase III to commercialization).
As Director, you’ll be at the forefront of shaping scientific strategy and optimizing the manufacturing process, ensuring that it meets the highest standards for efficiency, scalability, and compliance.
You shall collaborate closely with cross-functional teams to define process strategies, identify crucial parameters, and oversee technical transfers and process validations. Additionally, you are responsible for preparing regulatory documents and guiding the team through key milestones. You play a key role in fostering strong partnerships with stakeholders and clients, ensuring smooth technology transfers and addressing the evolving needs of the manufacturing process.
Qualifications:
PhD in Chemical Engineering, Biotechnology, Molecular Biology, Biochemistry or a related field.
Minimum of 10-14 years of experience in cell based therapeutics and bioprocess development.
At least 9 years of leadership experience in the biopharmaceutical industry.
Proven expertise in cell culture and cell therapy manufacturing, with a strong background in bioprocess modeling, process control systems, data analysis, and automation. Skilled in process FMEA, Quality by Design (QbD), Design of Experiments (DoE), and statistical analysis tools such as JMP.
Deep understanding of analytical methods to support process development.
Prior experience with global regulatory filings, IND and BLA submissions for cell therapy development.
Responsibilities:
Lead process optimization efforts to enhance productivity, improve yield, and ensure consistent product quality. Introduce cutting-edge manufacturing techniques to drive efficiency and innovation.
Oversee the execution of process validation and process qualification to ensure the process complies with regulatory standards and quality expectations. Design and implement control strategies for critical process parameters (CPPs) to maintain optimal performance and ensure product quality.
Oversee the creation of technical documentation for regulatory submissions (such as INDs, BLAs, etc.), ensuring full compliance with regulatory standards and that process development data aligns with the requirements for regulatory filings.
Create and execute risk mitigation plans to proactively identify and resolve potential issues. Lead technology transfer activities between development and manufacturing.
Form and guide a top-tier team of scientists, engineers, and technical specialists focused on process development. Promote strong collaboration between process development, manufacturing, quality, regulatory, and clinical teams to ensure smooth and efficient execution.
#J-18808-Ljbffr