Product Development Chemist II

PRIMARY PURPOSE or JOB SUMMARY

For the formulation of all approved and assigned products, development and validation of methods for the Product Development group.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. 1. Performs formulation research and development of approved and assigned projects in Product Development
   2. Responsible for method development, method validation, write-up, procedure writing, ensuring correctness of monographs (including location) and trouble shooting (and documentation) of assigned projects
   3. Evaluates suitability of new raw materials for new or existing products
   4. Provide analytical assays for new raw materials
   5. Write method validation protocols for pilot and production batches
   6. Assists in training personnel for transfer of methods from Product Development to Quality Control
   7. Use cGMP and cGMP documentation guidelines for performing analytical testing
   8. Responsible for basic maintenance and use of HPLC’s, Gas Chromatographs and other equipment in the product development laboratory such as the pH meter, density meter, centrifuge, TOC meter, shakers, dissolution apparatus, etc.
   9. Preparation of laboratory batches as needed. Assists in the choice of components for assigned projects as well as the design and testing of the new components.
   10. Assists in the scale-up of new or modified formulations to production-size batches and troubleshooting in Manufacturing at the request of operations management.
   11. Assists Regulatory Affairs in providing required documentation for ANDA submissions.
   12. Provides the Master Formula including manufacturing directions for new or modified products as assigned.
   13. Responsible for the stability studies on new products.
   14. Responsible for ordering laboratory supplies for assigned projects.
   15. Additional duties and responsibilities as assigned.

ACCOUNTABILITY

For the accuracy and timeliness of project development projects.

EDUCATION AND EXPERIENCE

4 year degree in chemistry or biology, plus 3 years experience in related field.

SUPERVISORY RESPONSIBILITIES

None

QUALIFICATIONS

Experienced Product Development Chemist requiring a minimum of 3 years experience in a pharmaceutical/medical products concern with an emphasis on laboratory controls. A technical degree in a scientific field is required.

No FDA sanctions.

EQUIPMENT AND MACHINES

Standard manufacturing lab equipment

WORKING CONDITIONS

Manufacturing lab environment

ADDITIONAL COMMENTS

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

PAI is an EO/AA Employer of Minorities/Females/Disabled/Veterans. PAI participates in E-Verify.