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Job description
The role requires understanding formulations, analytical development, equipment selection, stability profiles, and the roles these have in robust product manufacturing programs, ensuring all formulation and manufacturing activities incorporate these elements as necessary.
The Director will work with R&D, Analytical Services, Project Management, Formulation Development, and Manufacturing teams while collaborating with cross-functional teams internally and contract manufacturing partners externally on process development and manufacturing-related issues to resolve problems.
Core duties include directing and planning all production for formulation development batches, leading pilot-scale work, and managing the manufacture of GLP batches for partner companies as necessary.
The role drives the compilation of data and the use of performance metrics from cumulative batch processing to determine trends for monitoring quality and identifying process improvements.
Additional responsibilities include managing ongoing technology transfer and process validation to ensure comparability between internal pilot-scale manufacturing and external contract manufacturing, as well as reviewing contract manufacturing statements of work (SOW) to ensure internal pilot-scale efforts support all tech transfer and scale-up activities.
The Director identifies technical and logistical risks, proactively solves issues, and implements corrective actions to optimize manufacturing operations while ensuring all materials, equipment, documentation, and required facility support are correctly identified for reliable and reproducible operations.
Qualifications
Candidates must offer a proven track record leading successful manufacturing operations and teams for protein formulations in complex formulations, alongside experience establishing production schedules and development timelines per applicable product quality standards.
Serving as process owner, the Director plans to avoid delays and leads activities to ensure a robust, effective product and manufacturing process against development timelines.
The role involves overseeing stability studies required for product formulation selection, guiding root-cause analysis for process issues, and ensuring manufacturing precision.
Proficiency in cGMP manufacturing environments is required, including familiarity with cGMP manufacturing regulations for aseptic fill/finish products.
The position drives continuous improvement initiatives across manufacturing processes, equipment utilization, and operational workflows to enhance productivity and reduce costs during product development, tech transfer, and scale-up activities.
Leadership expectations include addressing technical challenges as necessary, supporting process development and transfers from R&D/pilot-scale to clinical production, establishing risk and mitigation strategies, and creating batch records and manufacturing processes based on technical, engineering, and development activities.
Candidates should demonstrate experience leading cross-functional sub-teams with subject matter experts in formulation and process scale-up from pilot scale to full clinical production. Proficiency in software tools such as project management platforms and document management systems is required for documentation and execution management.
Finally, the Director serves as a key scientific and technical representative for manufacturing process activities, reviewing project deliverables and providing ongoing scientific support.
Education
An M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field with at least 8 years of experience in pharmaceutical manufacturing is required, or a B.S. degree with 10 years of experience in the same field.
Candidates must demonstrate a proven ability to effectively lead complex projects and participate in teams, backed by a minimum of 3 years of supervisory experience.
Experience in senior manufacturing or development operations roles within a biopharmaceutical GMP manufacturing environment is necessary, including specific background in formulation and aseptic fill/finish, alongside familiarity with cGMP regulations and associated validation and qualification requirements for aseptic fill/finish products.
The role requires expertise leading manufacturing teams through development into pilot-scale manufacturing for formulation selection and stability profile support, as well as expertise in aqueous phase chemical formulations using a variety of solvents.
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Worksite address
morrisville, NC, 27560, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.