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Pharmaceutical Development Manager

Job Req # 566993

Pharmaceutical Company is looking for:

POSITION: Pharmaceutical Development Manager

LOCATION:? Caldwell New Jersey

SALARY:? $130-150+ Bonus

DEGREE:?? Required

EXPERIENCE:7-10 Years product formulations and development ? Solid / Oral Dosage Products

RELOCATION:? Assistance Available.

This new role has primary responsibility of providing scientific leadership in developing complex pharmaceutical products leading to successful IND/NDA filings and approval for solid/oral dosage products. The candidate will be responsible for timely development of products through internal development and through our partners.

Responsibilities

Responsible to provide guidance for all aspects of formulation/process development, scale-up manufacture submission/registration batches with efficient utilization of time/resources and proven successful tracking records.

Serves as subject matter resident expert in formulation development, process optimization of innovative products for small molecules/peptides/proteins.

Supervises and mentor scientists in developing innovative, complex formulations by effectively utilizing biopharmaceutical understanding in designing novel drug delivery and in-depth understanding of Quality by Design product development, FDA guidance and c-GMP compliance.

Supports Production/Manufacturing Department to ensure smooth transfer of new products into production/ manufacturing facility.

Manages internal/external projects independently within team environment

Communicates and presents development activities, findings and recommendations to the management.

Responsible for providing high quality IND/NDA documentation of product development with overall broad knowledge on regulatory aspects in a fast paced team environment.

Establish ?Critical Quality Attributes? for the drug products and ensure their consistencies from laboratory to scale-up/submission batches and commercial batches.

Review and approve all laboratory investigations, and support FDA audits as needed.

Qualifications

Degree in Pharmaceutics, Chemistry, and Bio/Chemical Engineering or related is preferred with minimum 7 years in the development of solid / oral dosage drugs

Proficient in the interpretation of and contribution to patents

Ability to interface with cross-functional teams with a high degree of flexibility

Goal-oriented, attention to detail, proven ability to complete projects on time and within budget



 

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