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Developmental Scientist - Formulations

Location: Northeast

Job Objective:

To develop formulations, conduct experiments and perform assays evaluating and reporting in support of product commercialization.

Essential Duties:

Conduct coating experiments in laboratory and pilot size fluid bed processor.

Evaluate and develop coating conditions/parameters in fluid bed processor.

Develop formulations for coating solutions suitable for fluid bed coating processes.

Prepare formulations for physical and chemical evaluation.

Design and perform short term stability studies.

Perform assays to evaluate formulations (HPLC, UV/VIS)

Perform dissolution testing on developed formulations.

Prepare, review protocols and development reports in support of commercial manufacturing, development projects and regulatory filings.

Participate in the transfer of manufacturing process laboratory to pilot scales.

Provide technical support to formulation related product issues.

Assure compliance of applicable FDA, DEA, DEC, OSHA, GMP, GLP etc. regulations.

Critical Competencies/Skills Required:

Ability to design and perform high level technical issues with minimal supervision.

Excellent written and verbal communication skills.

Effective team player when participating on cross-functional project teams.

Ability to resolve problems with independent thinking and high level technical skills.

Proficient in Microsoft Office applications.

Ability to deliver formal technical presentations; ability to supervise junior scientist and provide technical guidance.

Strong knowledge of GMP and pharmaceutical industry regulations.

Qualifications: (education, years of experience)

Ph.D. in Pharmaceutics or related fields with 3-5 years of experience in solid dosage forms formulation development and fluid bed coating in the pharmaceutical industry or M.S./B.S. in Pharmacy, Pharmaceutical Sciences, Chemistry or related areas with 5-10 years of pharmaceutical industry experience.

"Hands On" experience in small particle coating with fluid bed processing technology; experience in the development of formulation and technology transfer from laboratory to pilot scales in the area of solid dosage forms; thorough understanding of drug development process.

Basic analytical skills such as UV/VIS, HPLC is a plus; experience in suspension dosage form development is a plus.