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Pharma Drug Product Formulations Specialist

4 months ago

Cumberland, United States Tedor Pharma Services Full time

The Pharma Drug Product Formulation Specialist responsible for ensuring that all new products, processes and technical transfers are in a validate-able state as required for commercial manufacturing. This includes assisting with developing and executing strategies for new equipment qualification, technical transfers and process/cleaning validation.


Responsibilities:


Organize documentation (protocols, in-process sampling forms, reports, Master Formulas, SOP’s, Master Plans, etc.) to support product/process development and submission, site transfer, validation, equipment qualification and packaging studies.

Perform in-process sampling/ testing in support of batch manufacture.

Support the manufacture evaluation batches.

Assist with investigations to identify and rectify root causes of batch discrepancies or failures.

Assist Operations and QA personnel on new products/processes/equipment in order to successfully manufacture batches.

Participate in project teams as required.

Organize and execute projects with supervision from the Director.

Assist Director with implementing change and increasing productivity in response to ever changing business needs.

Coordinate the training of operations personnel on new technology, equipment or processes to assure successful transfer from research to operations.


Requirements:


Minimum B.S. in Pharmaceutical Science, Engineering or Technology or equivalent.

4-7 years of Pharmaceutical Manufacturing or Technical Services/Validation/Process Development related experience.

Solid Dose Manufacturing

Process Validation

Equipment Qualification

Assist in running and setting up compression, blending, granulation, coating, drying and encapsulation equipment at both a Pilot and Manufacturing scale is required.

Working knowledge of cGMP’s and SOP’s is essential.

Effective written and verbal communication skills.

Strong computer skills including Word and Excel.

Good analytical, problem solving, organizational and training skills.


Required experience: Pharmaceutical Manufacturing: minimum 2 years


Required education: Bachelor's


Job Type: Full-time