Associate Director / Director, Internal Cell Culture Development and Manufacturing

​The individual will require knowledge of cGMP manufacturing for early stage programs. The role possesses elements of both technical management and hands-on support, and it is expected the candidate will actively participate in both development studies and Pilot scale manufacturing.
The role involves significant cross functional collaboration with other functions, including research, external development/manufacturing, quality, and clinical operations. The role is both project and operations oriented that requires an ability to help drive and deliver elements of multiple projects running concurrently.

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Responsibilities (include but not limited to):

• Provide subject matter expertise in cell culture process development and manufacturing of biologics within a clinical stage GMP manufacturing environment

• Support external cell line development activities

• Design and execute development studies to support scalable early/mid stage biologics processes

• Debottleneck and rationalize processes to optimize process consistency, yield, and robustness

• Manage scale-up activities into single-use platforms to provide process demonstration and development team supply

• Manage the implementation and execution of clinical GMP upstream campaigns including raw material management, batch record authoring/review, change control, deviations, and summary reports

• Participate in due diligence assessments of research candidates and new business development opportunities

• Ensure that all activities are in-line with Quality Assurance and Regulatory requirements

• Contribute to preparation and submission of CMC sections of regulatory submissions and amendments

• Mentor staff and provide feedback on performance and areas for development

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Qualifications:

• Requires a BS plus 12 years or MS plus 10 years in Life Sciences, Chemical Engineering or related field

• Over five years of relevant biological process development and manufacturing experience with a strong record of achievement

• Experience in a cGMP regulated environment and a thorough understanding of regulatory/quality requirements for clinical stage manufacturing

• Hands-on experience with culturing cells, operating bioreactors, and harvesting cell culture

• using single use development and production equipment

• In depth understanding of environmental, nutritional and mechanical factors influencing cell growth, productivity and longevity

• Broad knowledge and hands on experience of disposable technologies up to a 500L scale

• Working knowledge of CMC regulatory requirements (FDA and EU) for early stage biological pharmaceutical products

• Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity

• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement

• Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance and quality requirements

• Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics

• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

• Ability to recognize areas for time and cost savings by developing strategies and leveraging internal capabilities

• Works cooperatively with other parties including late stage development/manufacturing,

• Quality Assurance, and Regulatory Affairs

• Team player with demonstrated experience working on cross-functional teams

• Demonstrated hands-on/roll-up sleeves approach to ensure that the job gets done

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Salary: On application