Pharmaceutical Process Development Specialist
1 week ago
**Overview:**
We are seeking a skilled Process Development Scientist for a contract opportunity with Yoh Scientific's client in Cambridge, MA.
This position is in the production lab of a major pharmaceutical company and requires a master's or bachelor's degree in a scientific field, along with industry experience with process characterization, process development, scale-up experience, and assay development preferred.
**Job Summary:**
As a Process Development Scientist, you will perform design and execution of experiments to support process development of advanced novel vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.
You will also perform process characterization / process development studies, data analysis, and support the development of new processes or improve existing processes using scientific expertise, literature review, or by seeking inputs from Subject Matter Experts.
Additionally, you will complete archiving of raw and processed data as per Company policy, operate and maintain designated lab equipment, train others as needed, and complete documentation of experimental results as per GMP/GLP regulations.
**Responsibilities:**
- Perform design and execution of experiments to support process development of advance novel vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.
- Perform process characterization / process development studies for the MAPS program.
- Perform data analysis from process characterization / process development studies.
- Support the development of new processes or improve existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.
- Support Tech transfer of developed processes to support GMP manufacturing.
- Complete archiving of raw and processed data as per Company policy.
- Operate and maintains designated lab equipment and train others as needed.
- Complete the documentation of experimental results as per GMP/GLP regulations.
- Complete the authoring of technical reports in collaboration with QA / RA / MSAT / ARD teams at GSK and assist in submission to regulatory agencies such as FDA.
**Requirements:**
- Masters/Bachelors in related fields such as Biochemistry/Biology/Molecular Biology/Chemical Engineering with 1+ years' experience.
- Industry experience with process characterization, process development, scale-up experience, and assay development preferred.
- Experience in DOE and JMP software preferred.
- Similar experience in protein purification and chromatography experience will be considered.
- Independent, detail-oriented, and organized with excellent oral and written communication skills.
- Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.
- Able to maintain written records in the form of laboratory notebooks.
**Benefits:**
- Medical, Dental & Vision Benefits.
- 401K Retirement Saving Plan.
- Life & Disability Insurance.
- Direct Deposit & weekly ePayroll.
- Employee Discount Programs.
- Referral Bonus Programs.
**Estimated Salary Range:** $50 - $53.06 per hour depending on experience, W2.
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