COMPANY: Collegium Pharmaceutical, Inc. (www.collegiumpharma.com)
JOB TITLE: Project Manager – Contract Manufacturing
LOCATION: Cumberland, RI

The Company:
Collegium Pharmaceutical is a privately held, venture backed, commercial stage, specialty pharmaceutical company dedicated to the development of proprietary, late stage pharmaceutical products that add market value and clinical benefit to existing drugs. We apply customized pharmaceutical formulations and intellectual property (IP) strategies to drugs that are safe and effective, creating a portfolio of improved pharmaceutical products with a shorter time to market. Collegium uses its broad expertise in IP development, drug formulation, manufacturing, basic science (chemistry, biology, bioengineering), marketing and clinical trials management to identify and maximize opportunities for ourselves and our partners.

JOB DESCRIPTION:
Collegium Pharmaceutical, Inc. is seeking a highly talented and self-motivated professional to join our team as a Project Manager – Contract Manufacturing to manage several key Collegium products that are developed and manufactured at external contract manufacturers. The products are solid oral dosage forms.

JOB RESPONSIBILITIES:

• Serve as Project Manager for Contract Manufacturing sites for several key products in solid and semi-solid oral dosage forms.
• Evaluate and select manufacturing sites, and necessary equipment to support a variety of company products.
• Serve as key contact for these external Contract Manufacturing sites and provide guidance to manufacturing process and analytical methodology.
• Coordinate and resolve manufacturing and analytical development/QC testing issues such as deviations, OOS, and investigations.
• Ensure that both Collegium and the Contract Manufacturers perform their obligations to any agreed contracts.
• Serve as an active member of a multidisciplinary team within the company and with outside Contract Manufacturers.
• Ensure that Contract Manufacturers comply with all aspects of cGMP, Safety, DEA, Environmental legislation, and company policies
• Undertake studies in support of product development
• Support the preparation of the chemistry, manufacturing and controls portion for IND/NDA/ANDA submissions
• Provide equipment project updates to immediate management, and/or senior management, as requested.
• Must be able and willing to travel to Contract Manufacturing sites.

JOB REQUIREMENTS

• Ph.D., M.S. or B.S. in Pharmacy, Chemistry or Chemical Engineering with a minimum of 3-5 years experience in managing or actively participating in Pharmaceutical Contract Manufacturing and product development activities.
• Hands on experience in the evaluation and selection of Contract Manufacturing sites
• Knowledge and understanding of the Design Qualification, Installation Qualification, Operation Qualification and Performance Qualification of pharmaceutical manufacturing equipment and facilities.
• Understanding of GMP, ICH and FDA guidelines, and the general requirements for pharmaceutical manufacturing.
• Formulation, Process, and analytical development experience in solid oral dosage forms.
• Ability to work independently and in a team environment.
• Must be willing to be “hands on” or to train and direct junior staff as required.
• Highly effective interpersonal, organizational, oral and written communication skills.
• Proactive and innovative problem solving skills.
• Creativity, imagination, and ability to transform ideas into patentable and marketable products and processes.
• Must be willing to travel domestically or internationally up to an average of 20%.

Submit Information:
Submit cover letter and resume via e-mail to careers@collegiumpharma.com or mail to Attn: Human Resources, Collegium Pharmaceutical, 400 Highland Corporate Drive, Cumberland, RI 02864.