Liquid Formulation Scientist

***Candidates must be either a US Citizen or Permanent Resident***

 

NASAL SPRAY FORMULATION A PLUS!!!

 

DUTIES:

 

Lead the rational design,development and scale-up of formulations and processes for new generic drug products under the guidance of Principle Scientist/Director/Sr. Director. Support ongoing manufacturing of new and currently marketed products by providing technical and scientific assistance.  Support ?Continuous Improvement? of new and current products.  Comply with company standard operating procedures and currently accepted practices in cGMP and Compliance to enssure product quality, safety, and efficacy.  Keep accurate, complete, up-to-date records of all work done. Initiate new product stability studies, evaluate results and assist with decision process.

 

1.Design and perform experiments leading to the development of rational, scientifically sound formulations and manufacturing processes, as directed by  a manager

 

2.Provide leadership to Scientist when appropriate.

 

3.Support regulatory submissions as needed.

 

4.Review compendial requirement for use of excipients and also patent literature.

 

5.Write specifications for finished product and packaging components.

 

6.Write master formula, manufacturing procedures, stability protocols, SOPs, and product development reports.

 

7.Design and initiate stability studies on selected batches of products.

 

8. Evaluate relevant characteristics of raw materials and experimental batches in effort to develop robust manufacturing processes.

 

9. Oversee manufacture of products using production equipment, such as batches for ANDA submissions, bioequivalence studies, and/or process scale-up studies.

 

10. Perform product/process validation when required, including designing procedures, overseeing batch sampling, and analyzing data.

 

11. Coordinate with analytical chemists in the Quality Control and Method Development Laboratories for completing testing of new drug products in a timely manner, and development of appropriate control s.

 

12.Coordinate scheduling and production of pilot scale and submission batches with Manufactuirng Operations and Quality Systems.

 

13.Support  qualification, calibration, and maintenance of R&D instruments/equipment.

 

14.Responsible for documentation of all activities as per cGMPs and cGLPs.

 

15.Develop and maintain knowledge pertaining to cGMP documents and guidances, other FDA/ICH guidances and MGP SOPs.

 

16. Perform other tasks as assigned by the supervisor.

 

 MUST

 

? M.S. or Ph.D. in Pharmaceutical Sciences or related field.

 

? Good communication (oral and written) skills, self-motivation, and organizational ability.

 

?5+ years for M.S. and 3-5+ years for Ph.D. in pharmaceutical product development, specifically in semi-solid and liquid dosage forms and sustained-release products.

 

Requires experience in the pharmaceutical industry, particularly in research and development as well as regulatory documentation