Pharmaceutical Clinical Associates, LLC
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Raritan ,
NJ
GENERAL SUMMARY
This position is responsible for the technical support of the manufacturing operations. This position will report to the Director or Associate Director in Manufacturing Technology and will interact with engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with contract producers of company products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is essential. Database experience a plus.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job.
The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
Responsible for supporting manufacturing operations through the performance of the following duties:
1.Trends and analyses production data.
2.Troubleshoots issues in conjunction with manufacturing staff. Communicate issues in a timely manner.
3.Assists in the transfer of processes and process improvements from process development to the production facility and from one production facility to another.
4.Authors technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending.
5.Ensures cGMP compliance.
6.Works with validation to support the start-up of new facilities and validation of existing facilities.
7.As required, assists in the planning and execution of process validation activities. May be asked to support additional projects in Manufacturing Support & Process Validation group.
Experience and Skills:
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE
1.BS degree in Chemical Engineering, Microbiology, Biochemistry or Chemistry.
2.A minimum of 7 years relevant experience in a GMP production/development environment.
3.Demonstration of superior performance as a Manufacturing Engineer III or an equivalent position.
4.Previous supervisory experience of 1-2 years.
5.Experience in fermentation and/or protein purification manufacturing.
6.Process and equipment knowledge of cell culture and purification functions.
7.Thorough understanding of GMP requirements for a large scale manufacturing facility.
8.Process validation experience a plus.
9.Excellent communication skills, both oral and written.
Additional Information:
Job Level: Any
Number of Openings: 1
Years of Experience:
Level of Education: Any
Salary: TBD
Starting Date : April 1, 2010
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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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