COMPANY: Collegium Pharmaceutical, Inc. (www.collegiumpharma.com)
JOB TITLE: Scientist, Analytical Development
LOCATION: Cumberland, RI

The Company:
Collegium Pharmaceutical is 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 is seeking a motivated and talented Analytical Scientist to join our development team. Candidate must be able to function in a rapidly evolving environment, be willing to multitask and take on additional responsibilities as necessary.

JOB RESPONSIBILITIES:

• Execute analytical programs in support of drug delivery and formulation development with a high degree of independence
• Develop, modify and validate analytical methods to support the formulation needs and regulatory filings using various instrumental techniques.
• Extract target analytes from sample matrices using various extraction techniques, such as liquid-liquid, reflux and SPE
• Perform stability studies on experimental formulations and finished dosage forms
• Maintain stability programs for in house development projects
• Troubleshoot dosage forms stability using advanced physico-chemical methods of analysis, determine degradation pathways and elucidate structure of degradation products
• Conduct solid-state characterization of drug substances and excipients to assure their suitability for the intended formulations and processes
• Design and conduct in vitro drug release testing of solid and semi-solid formulations including various dissolution techniques and Franz cell
• Identify and implement new technologies to enhance the analytical capabilities of the department
• Participate in cross functional teams and internal collaborations
• Discuss technical aspects of the outsourced projects with contract research organizations
• Write and review protocols, reports, procedures, and test methods
• Maintain laboratory equipment and logbooks in compliance with governing regulations
• Comply with all aspects of cGMP, Safety, DEA and Environmental legislation and with company policy.

JOB REQUIREMENTS

• Ph.D. with 2-5 years or a BS/MS with >5 years experience with a degree in Chemistry or a related science. The Applicant must have experience in small molecule analytical development for pharmaceutical drug products.
• Must have experience with HPLC, GC, dissolution, method development/validation, PSD and knowledge of GMP, FDA, and ICH regulations.
• Proficient in various methods of analyte extraction.
• Familiarity with CMC requirements for ANDA and 505(b)2 dossiers.
• Candidate should be familiar with various dosage forms such as solid oral, topical, and inhalation, as well as controlled release formulations.
• An understanding of pharmaceutical microbiological testing is a plus.
• All applicants must be eligible to work in Massachusetts and reside in the greater Boston area.

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. Job Code is SAD-KJ.