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.
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
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
Salary: On application
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