Senior Research Scientist

Regular
16 Elkins, East Brunswick
Posted 6 months ago

Job Summary:

 

The Senior Research Scientist role is responsible for supplying strategical expertise on finished drug production, and manufacturing process technology. The technical expertise and process technology support can be used in problem solving as well as in continuous improvement activities.  The Senior Research Scientist will work across the development/scale up/technical transfer projects. Working with subject matter experts, operation and quality. Senior Research Scientist will be responsible for development/validation/investigation report with appropriate justifications, conclusion and recommendations.

 

Reporting Relationships                                                                                 

 

  • This position has no direct reports
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  • Essential Functions:

     

    1. Coordinate development activities for each drug product with the respective departments.
    2. Provide technical expertise and guidance for troubleshooting & problem-solving activities related to process and product investigations.
    3. Perform activities related to the formulation and process scale-up activities.
    4. Identify & select the appropriate ingredient required for use in new product development and perform scientific review for specification of raw materials and coordinate with suppliers as appropriate.
    5. Oversee manufacture of products using production equipment, such as batches for ANDA submissions, bioequivalence studies, and/or process scale-up.
    6. Provide technical support of ongoing manufacturing for new and currently produced products at the site.
    7. Work proactively with QA, Manufacturing, and other groups and coordinate/manage manufacture of registration/bio, validation, and initial commercial batches.
    8. Review master manufacturing batch records, process characterization protocols, and equipment SOPs.
    9. Develop components of the product development report, process development report, and process parameter justification reports.
    10. Maintain knowledge pertaining to cGMP documents and guidance, other regulatory guidance and GMP SOPs and comply with company standard operating procedures and currently accepted practices to assure product quality, safety, and efficacy.
    11. Support preparation of CMC documentation for the FDA and other international regulatory submissions. Assist in getting ready for pre-approval inspection (PAI).

      Specialized Skills and Knowledge:                                                                                 

       

      1. Education/Certifications:
        • S. in Pharmaceutical Science or related discipline plus a minimum of 6 years’ experience.
        • S. in Pharmaceutical Science with 4 years of experience.
        • D. in Pharmaceutical Science with 2 years of experience.
      2. Indirect supervision, mentoring, and negotiating skills.
      3. Knowledge of Technical techniques to evaluate formulations, immediate and modified release dosage forms, technology transfer methodologies, or advanced unit operations.
      4. Area of specialization at least 5 years’ experience.

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Job Features

Job CategoryR&D

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