VP of Product Development

VP of Product Development   
SRG offers flexible staffing solutions with a national presence.  We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

• Location: Great Tampa Bay, FL
• Industry: Pharmaceutical
• Hours: M-F, 8am-5pm
• Employment Type: Direct hire
• Salary: Competitive compensation package  

Environment: We are searching for a talented and motivated individual to fill the position of VP-Product Development in our clients team-oriented facility in the Tampa, Florida area. Our client focuses on critical care, anesthesia and/or therapeutic areas and aiming to become a top producer in the injectable market in the United States.  The goal is to provide supply chain security and reliability as a US based manufacture for essential medicines.

Responsibilities include:
The employee should successfully meet schedules in a high quality and professional manner and ensure production/packaging areas and work areas conform to cGMP, Standard Operating Procedures and Corporate Policies. Maintain the GMP areas in a state of control at all times.
This position will assist with new product and process development including prototype development, formulation optimization, lab stability, document creation, process design and optimization, pilot scale-up and process optimization to full scale batch size.
This position will assist or develop submission documentation and be a point of contact for regulatory authorities with relation to the submission and approval process.
This position will be instrumental in the evaluation and due diligence review of contract business and Business Development opportunities.
This employee will assist manufacturing personnel in performing dispensing, manufacturing, and packaging operations following approved Batch Records and routine trouble-shooting and cleaning of complex equipment.  Specifically, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs) or written work instructions.  Specifically:

• Assist in the development and tracking of department budgets
• Work with management and board to develop company pipeline
• Evaluate and implement CMO/CDMO opportunities for external clients from a development perspective
• Develop injectable formulation IP for 505(b)(2) and/or IND assets that can be develop commercialized internally or through out-licensing
• Act as regulatory contact for all filings
• Act as a mentor to less experienced staff
• Assist with training and perform on-the-job training of manufacturing and laboratory technicians
• Formulation development and optimization using Good Laboratory Practices (GLP) principles
• Process development and optimization studies using GMP principles
• Identify and correct problems Assist the Manufacturing and QC Supervisor as required
• Work as a cross-functional team member to coordinate manufacturing operations with Quality Control and Quality Assurance
• Identifies and implements continuous improvement projects
• Assist in equipment qualifications
• Evaluate and spec equipment necessary
• Preparation Room Activities

• Documentation
  • Complete all documentation as per procedures and policies and cGMP regulations
  • Review controlled documents such as batch records, sterilization and cleaning logs for accuracy and completeness as part of transfer activities.
  • Prepare documentation, batch records, general forms and ensure the documentations is correct and complete and in compliance with cGMP, corporate standards and procedures as part of transfer activities.
  • Pay strict attention to errors and omissions in all documentation and initiate corrections

Required Qualifications:

• PhD degree in Pharmaceutical science, Chemical Engineering or related fields.  The position requires at a minimum 10 years experience in the pharmaceutical industry in a development role.  Computer skill in Microsoft Excel and Word required. Good verbal and written communication skills.  Good interpersonal and supervisory skills.
• Experience working in a product development capacity, especially in new and/or generic drug development.
• Experience with FDA requirements for GMP, GLP, ANDA, IND/NDA applications
• Experience in product development of liquids, and suspension dosage form development preferred.
• Proven track record of taking formulations through development and submission
• Ability to write and review product development reports.
• Ability to write CMC section submissions.
• Proven knowledge of scientific principles, manufacturing equipment and physical pharmacy.

ADA/EOE