Formulation Specialist

POSITION SUMMARY: The Formulation Specialist will assist the Formulation Scientist with hands-on formulation development and implementation of the GMP manufacturing process. They will also provide technical and scientific expertise in developing the formulation of those products which includes formulation strategies, various formulation prototypes, analytical method development and data analysis.

RESPONSIBILITIES:

1. Hands-on development of various formulations such as injectables, gels, vaginal inserts and vaginal ring for sexual and reproductive health, including contraception alone and for Multipurpose Prevention Technologies (MPTs) to simultaneously prevent HIV, other sexually transmitted infections (STIs)

2. Perform physico-chemical characterizations and pre-formulation work

3. Establish the scale-up of the manufacturing process from prototype to lab scale

4. Hands-on technical manufacturing and GMP manufacturing of drug products in a clean room facility

5. Assist in the drafting and reviewing of the technical batch and GMP manufacturing batch records including certificate of analysis

6. Establish bioburden or sterilization process, packaging and integrity testing of the packaged drug products

7. Coordinate and monitor outside vendors for testing services

8. Perform in-house testing which includes in vitro release rate testing, assay, and degradation of the active pharmaceutical ingredients

9. Perform in-house stability studies on both technical and GMP drug products

10. Assist in drafting & reviewing new analytical methods, manufacturing records, and data generated by the lab

11. Understand and follow GMP SOPs and maintain GMP compliance

12. Provide guidance, feedback and assistance to the lab staff with existing projects in the lab

QUALIFICATIONS:

We understand that there are many paths to acquiring expertise and experience and strong candidates may not have every qualification listed here. We encourage applications from individuals who bring passion, skills, and experience in many or most of these areas.

1. Ph.D. in pharmaceutical sciences, chemical engineering, chemistry and related discipline with a focus on bench work and instrumentation

2. Minimum 2-3 years of post-doctorate experience. Exceptional candidates with less experience will also be considered.

3. Hands-on experience in carrying out experiments and data analysis

4. Knowledge of how to perform design of experiments

5. Computer skills with utilization of Microsoft Office (Outlook, Word, Excel, PowerPoint, etc.) required.

6. Problem solving skills required, preferred experience with laboratory investigations

7. Must be able to work autonomously and collaborate with the lab staff

8. Highly self-motivated