Research Associate/Sr. Research Associate - Upstream

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Location
Tustin, CA
Job Type
Direct Hire
Date
Jan 22, 2019
Job ID
2644097

My client is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  They provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  They have 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  They also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.


 


Summary and Qualifications


My client is seeking a Research Associate/Sr. Associate, Process Development who is interested in pursuing a career in developing biologics and pharmaceutical agents. The Research Associate/Sr. ("RA") will assist process development in developing and optimizing scalable processes with improved product yield and reduced costs for manufacturing systems. In addition, the Sr. RA may assist with the maintenance of production equipment and may research and implement new methods and technologies to enhance process operations.


 


Essential Duties and Responsibilities include the following; other duties may be assigned:



  • The Sr. RA will be responsible for mammalian cell culture process development to produce recombinant proteins, media screening, adaptation to suspension, adaption to serum free, comparing growth and productivity in various media, growing and maintain cells in T-flasks, spinner flasks and shake flasks.
  • Provide and lead technical support with cell culture solutions to Process Development and Manufacturing teams.
  • Lead studies to help optimize cell culture conditions.
  • The Sr. RA will also work with many different kinds of mammalian cell lines, and apply a good understanding of the effect of general metabolic pathways (nutrient usage, expression system, etc.) physical (morphology, pH, osmolality, etc.) as well as mechanical (column, agitation speeds, oxygen and pH control, etc.) parameters on cell growth and production.
  • Operate and troubleshoot cell culture equipment such as bioreactors and analyzers; and optimize lab/pilot/manufacturing scales and process/tech transfer to the Manufacturing department.
  • Research and implement new methods and technologies to enhance operations, clarification filter sizing, culture media and supplement/feed preparation, utilize aseptic techniques, analyze growth, production and nutrient usage data, create data spreadsheets in Excel, document data and findings for traceability and regulatory requirements, write technical and summary reports, and lastly, communicate findings and participate in scientific discussions within the group.
  • May recommend alternatives, research new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.
  • Develops skills in data analysis and ability to evaluate quality of data.

 


Education and Experience


 


This position requires a B.S. degree in Biological Science, and a M.S. degree in Biological Science is highly desirable. Must have a minimum of 2 to 4 years of relevant industry experience with demonstrated working knowledge of scientific principles. Will accept 1 to 2 years of pharmaceutical industry experience for candidates with Master's degrees. The employee must also have demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials is required. Should have experience in managing multiple projects in a fast-paced environment coupled with strong interpersonal and organizational skills. The ability to operate both independently and in team settings while utilizing excellent oral and written communication skills s essential. Prior experience in and/or an understanding of cGMP, knowledge and experience in statistics and DoE is a plus. Prior experience in process validation and responsibilities include process validation studies is also required. The ability to read and understand scientific literature and follow instructions both written and oral is expected of the employee.


 


Work Schedule and Hours


 


Any scientific staff member can expect to work overtime, including during the weekends. Off-site seminars and conferences, as well as, off-site meetings with clients and regulatory agencies, are a usual occurrence.  Occasional overnight travel by land and/or air may be required


 


EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER


 


Lieberman Consulting, LLC and our clients do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.


 


Keywords: Upstream, Mammalian Cell Culture, Monoclonal Antibodies, mAbs, Protein Therapy.