Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
Job Description -
A working knowledge of cell culture techniques, process and media optimization, bench scale bioreactor operations, scale-up and process transfer. Position requires the ability to develop production processes for proteins that are intended for human use. Familiarity of cGMPs in terms of practice and documentation is essential. The ability to interact and convey ideas in a way that ensures good process transfer to Manufacturing groups within company or outside CMO's . Ability to develop analytical approaches that aid in the development of an optimized production process is a plus. Able to interact with junior members of the group in planning daily activities. Position requires the ability to trouble shoot and work independently to resolve any problems that might occur.
Development of production process for proteins using bench scale bioreactors or other models.
Ability to analyze data, interpret results and draw conclusions from process related experiments.
Scale-up of bench scale production processes and process transfer.
Process optimization in bench scale bioreactors for various key process parameters.
Maintains laboratory notebook.
Writing of SOPs, development reports and supporting documentation.
Maintain high level of scientific knowledge by attending seminars, conferences etc.
Technical involvement with validation studies (i.e. range evaluation studies).
Ability to plan experiments that effectively move projects along.
Responsible for planning day-to-day activities of Junior Staff members.
Experience and Skills:
Experience -
Requires a B.S. and a minimum of 5-7 years of related experience or an M.S. and a minimum of 3-5 years of related experience.
In depth knowledge and prior experience with aseptic cell culture techniques, small-scale cell culture process development and hands-on bioreactor operations including scale-down model systems is required.
A good working knowledge or prior use of statistical design of experiments (DOE) is desired.
Ability to manage several different projects and good communication skills.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan, NJ
Raritan, New Jersey
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