Sr. Scientist, Formulation Development - 3473

 

 

Develop and/or trouble shoot standard and complex pharmaceutical solid (tablet/capsule) and oral liquid dosage forms that are stable, bioequivalent to the brand product, and robust/manufacturable according to the defined Intellectual Property (IP) strategy.  Complete Registration Lot manufacture and provide documentation in support of QbD (Quality by Design) principles for the Regulatory Filings.

 

Responsibilities

 

• Regular and predictable onsite attendance and punctuality.

• Works within project team structure with minimal to no direct supervision to develop and/or trouble shoot standard to complex new formulations for oral solid and liquid dosage forms, which may include potent compounds or DEA controlled substances as assigned.
• The project scope includes those of increasing complexity, such as immediate release solid dosage forms of BCS (Biopharmaceutical Classification System) Class 2 and 4, suspensions, modified, controlled, or extended release products, powders for oral suspension, nasal suspensions, and/or moderately difficult IP strategy.
• The project scope may include developmental efforts utilizing 3rd party organizations and may require international travel.
• Departmental technical resource for formulation and processing techniques of multiple process trains and equipment.

• To develop robust, stable, and bioequivalent dosage forms for regulatory filing and launch.
• Generates, collects and reviews data on developmental lots to determine the most optimal formulation and manufacturing process in support of QbD requirements with respect to stability, bioequivalency, robustness and IP strategy.
• Manufacture an adequate number of developmental lots and study the correct variables to assure success.  Design complex experiments to obtain required data. 
• Complies with laboratory and regulatory requirements, such as WI’s, SOP’s, OSHA, DEA, and cGMP’s and influences critical review of the requirements.
• Manufacture an adequate number of developmental lots and study the correct variables to assure success.  Design complex experiments to obtain required data. 
• Utilize project management skills to influence and direct the execution of project milestones.

• Mentors Technicians and/or junior Scientists to assist in attainment of objectives as assigned.
• Plans, observes, and coordinates the manufacture, packaging, and disposition of the Pilot and Registration Lots. 
• Assists, consults, and trouble-shoots during scale-up and validation activities. Supports assigned projects throughout the lifecycle of the product as the Subject Matter Expert (SME).
• Generate and/or review the required documentation to justify the formulation and process selected. 
• Obtain the required samples and perform the attendant testing. 
• Record personal observations and provide consultation during the manufacturing and packaging of the Registration, Scale-Up and/or Validation Lots.
• Reviews and collects data on Pilot and Registration Lots. 
• Incorporates the data in the required Technical Reports, including the Pharmaceutical Development Report in support of QbD for the regulatory filings. 
• Provide technical input for FDA CMC and DBE deficiencies as required.
• Conducts the proper experiments and collects the appropriate data to justify the product specification and support the approval of the product via the QbR/QbD documentation and required regulatory filings.
• Leads strategic teams within the department and participate on cross-functional teams.
• Successfully interacts within and outside the department to accomplish project, departmental and corporate goals.
• Demonstrates the appropriate skills to successfully influence the team to accomplish the task. 

• Participates in the generation of the intellectual property strategy.  Identifies opportunities and participates in the development of intellectual property for assigned projects. 
• Reviews appropriate patents, literature, and prior art for applicability to assigned projects.  Utilizes the Record of Invention form for documentation of the prospective intellectual property.

 

Qualifications

 

• B.S. in scientific field (pharmacy, chemistry, or engineering is preferred) with 6 years relevant pharmaceutical experience, or
• M.S. in pharmaceutics or related scientific discipline with 4 years relevant pharmaceutical experience, or
• Ph.D. (preferably in Pharmaceutics) with 1-year experience
• Understands factors that drive Product Development’s performance and prioritizes issues accordingly
• Applies expert knowledge of the formulation development process, processing equipment, regulatory policies and general prac