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COMPANY: Collegium Pharmaceutical, Inc. (www.collegiumpharma.com)
JOB TITLE: Scientist / Manager, Topical Formulation Development
LOCATION: Cumberland, RI
JOB DESCRIPTION:
Collegium Pharmaceutical, Inc., a rapidly growing specialty pharmaceutical company, is seeking a Formulation Development Scientist / Manager for our Topical Product Development Group. As a member of our team, you will be working with and learning from experienced pharmaceutical professionals designing new and innovative topical formulations in support of Collegium’s growing topical dermatology pipeline.
JOB REQUIREMENTS:
- B.A., B.S. or M.S. degree or equivalent in the physical sciences, biological sciences or engineering with a minimum of 3 years experience formulating topical pharmaceutical or cosmetic products.
- Demonstrated ability to work independently as well as in a team environment.
- Demonstrated willingness to work “hands-on” in the laboratory.
- The potential to manage and mentor junior staff.
- Highly effective interpersonal, organizational, oral and written communication skills
- Proactive, innovative problem solving skills
- Creativity, imagination, and the ability to transform innovative ideas into topical products with well-defined competitive advantages
JOB RESPONSIBILITIES:
- Lead the design and execution of formulation development programs to deliver specific topical dermatology product attributes including:
- Design of experiment (DOE) studies to substantiate formulation excipient choice and use levels
- DOE studies to optimize desired product aesthetic attributes
- In vitro release studies of prototype formulations
- ICH accelerated, intermediate and long-term stability studies
- Communicate formulation development program status, goals and timelines to immediate and/or senior management on a regular basis by:
- Evaluating and interpreting study data for immediate and/or senior management on a regular basis
- Writing detailed technical reports on completed formulation development programs and periodic reports of on-going programs
- Assist in the development of commercial manufacturing processes and scale-up activities
- Assist in the preparation of 510(k) Pre-market approval documents
- Assist in the preparation of the Chemistry, Manufacturing & Controls (CMC) sections of IND, ANDA and NDA submissions
- Evaluate clinical and scientific literature to identify potential product differentiators and new product opportunities
STATUS: Regular Full-time
Submit cover letter and resume via e-mail careers@collegiumpharma.com or mail to Attn.: Human Resources, Collegium Pharmaceutical, 400 Highland Corporate Drive, Cumberland, RI 02864. Job code is FDSMTPRD-MT.
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