Process Development – Process Development Laboratory Supervisor

JOB SUMMARY:

Process Development Laboratory Supervisor is responsible for leading laboratory staff in the execution of test plans aimed at developing robust, scalable downstream manufacturing processes that meet minimum purity & safety requirements while optimizing productivity measures using routine and novel techniques & methodologies in addition to assisting in the running of the lab.

 

MAJOR RESPONSIBILITIES:

 

The successful candidate will contribute to the successful execution of test plans to develop robust, scalable downstream manufacturing processes to meet minimum purity & safety requirements while optimizing productivity measures using novel techniques.  The target candidate will provide direction to a group of scientists to design and execute process development studies to meet assigned deliverables as well as prioritize activities according to work scope and resource allocation.

 

The target individual for this position will posses minimum of 8 years of hands-on experience creating & executing comprehensive scale-down plans to improve productivity processes at manufacturing scale. Additionally, the candidate will have demonstrated the ability to mentor and lead junior associates in test plan execution and lab equipment operation in the development and characterization of chromatographic and membrane processes.

 

Responsibilities include:

 

  • Overseeing day-to-day laboratory operations.
  • Overseeing the execution of test plans development of robust processes that scale well with good manufacturing fit.
  • Support project test plan design and execution.
  • Hands on work in the lab to execute test plan.
  • Experimental design and execution, analysis of data, and making logical data based conclusions with applicability to project goals.
  • Generate thorough, statistically vetted reports to demonstrated process capability and scalability
  • Proficiency with downstream process lab equipment including automating test equipment to facilitate rapid design space evaluation and troubleshooting equipment issues.
  • Maintenance of lab facility, equipment upkeep, and technical improvements.
  • Execution of proof of scale-up studies with manufacturing & engineering support for troubleshooting of late stage process development challenges.
  • Author related aspects of CMC section for submission to regulatory bodies.
  • Interface with regulatory agencies to present and defend process development and characterisation strategy and executed studies, as needed.

 

 

MINIMUM QUALIFICATIONS:

 

TECHNICAL KNOWLEDGE/EXPERIENCE:

 

  • Degree in engineering or life sciences.
  • B.Sc. with 4 – 8 years of relevant industrial experience in bioprocess downstream development and characterization.
  • Demonstrated ability to mentor and lead laboratory staff.
  • Must have hands on experience running chromatographic and membrane process lab equipment for the development of robust bioprocesses.
  • Demonstrated ability to design and execute scientific studies with technical excellence and relevant results.
  • A detailed understanding of process development manufacturing fit, process characterization, tech transfer/scale-up experience is required.
  • Strong working knowledge of statistical software for design of experiment and data analysis.

 

BEHAVIORAL:

 

Demonstrated ability to apply the following behavioral competencies on the job:

Independence: Ability to work with minimal supervision

Flexibility: Agility in adapting to change

Problem Solving: Anticipating, analyzing, diagnosing and resolving problems

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

Interpersonal Skills: Effectively communicating, building rapport and relating well to all kinds of people.

 

PREFERRED QUALIFICATIONS:

 

  • Experience in top-tier biopharmaceutical environment
  • Knowledge of cGMP & GLP

 

 

 

 

 

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