Careers

Manager, Process & Formulation Development

CPL is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry. 

An exciting opportunity exists to participate in the further development of operations that meet the highest customer and regulatory expectations. The successful individual will be eager to enhance their career and professional growth while contributing to the ongoing success of a fast paced expanding contract pharmaceutical manufacturer.

SPECIFIC RESPONSIBILITIES:

  1. Responsible for the day-to-day operation of all aspects of process and formulation development for all CPL sites.
  2. Identify and recommend human, financial and physical resources required to fully develop pharmaceutical development capability
  3. Develop applicable standard operating procedures and business processes related to delivery of development services.
  4. Assist in the development of proposals related to business development activities.
  5. Develop pharmaceutical development protocols, studies and associated reports including related CMC, or other filing documentation as needed.
  6. Work collaboratively with CPL analytical laboratories (method development, validation, forced degradation, preservation, etc) to support pharmaceutical development and with CPL Purchasing for material sourcing.
  7. Participate on technology transfer project teams to facilitate new process/formula integration and troubleshooting through validation and into commercial manufacturing.
  8. Support commercial manufacturing process improvements and cost reduction strategies based on formulation improvements/enhancements.
  9. Recommend, cost justify and coordinate implementation of all related capital projects pertaining to formulation/process development.
  10. Ensure all activities comply with applicable regulatory requirements and customer expectations.
  11. Prepare and manage department cost center budget.
  12. Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by CPL; reports any injury or illness immediately and notifies CPL of any hazards, unsafe acts or conditions in the work place.
  13. Other duties as assigned

QUALIFICATIONS:

  1. Ph.D. in Pharmaceutics/Pharmaceutical Sciences (preferably with depth in liquid and semi-solid dosage forms) with a minimum of 7 years experience in pharmaceutical development and 3 years experience in management.
  2. Proven track record of drug product development through commercialization.
  3. Practical working knowledge of FDA CMC/CTD/cGMP and ICH guidelines related to pharmaceutical development.
  4. Understanding of container/closure systems and applicable delivery system features and benefits, material compatibility and microbiological attributes.
  5. Strong project management skills and experience as member of multidisciplinary teams.
  6. Excellent interpersonal and customer interaction skills.
  7. Strong attention to detail, able to integrate needs of chemistry and engineering successfully in formulation and process development.
  8. Entrepreneurial spirit, driven to help grow a new service offering within an established successful business.


CPL Niagara
100 Forest Ave.
Buffalo, NY  14213
Attn:  Human Resources Dept.
Fax to 887-7706
Or e-mail to hrniagara@cplltd.com

We thank all applicants in advance for their expression of interest; however, only candidates selected for an interview will be contacted.  No telephone or agency inquiries please.