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Pharmaceutical Development Manager

Job Req # 556993


Pharmaceutical Company is looking for:


POSITION: Pharmaceutical Development Manager


LOCATION:? Caldwell New Jersey


SALARY:? $125-145K + Bonus


DEGREE:?? Required


EXPERIENCE:7-10 Years product formulations and development ? Generics a must?


RELOCATION:? Assistance Available.


This new role has primary responsibility of providing scientific leadership in developing complex pharmaceutical products leading to successful ANDA/NDA filings and approval for generic 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 ANDA/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


PhD. in Pharmaceutics, Chemistry, and Bio/Chemical Engineering or related is preferred with minimum 7 years in the development of generic 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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