Sr. Research Scientist
Rhodes Pharmaceuticals L.P. has developed and distributed quality pharmaceutical products nationwide since 2008. With our R&D capabilities, industry partnerships, broad customer base, and strong relationships with suppliers, we offer reliable supply of high-quality products at competitive prices. Rhodes is a wholly-owned subsidiary of Purdue Pharma L.P.
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to our Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!
This position will act as analytical lead and support drug development through analytical method development, validation, transfer, stability testing and activities to support formulation development and clinical studies in compliance with all applicable guidelines with minimum supervision. This role may independently identify/observe problems and recommend experimental strategies and solutions. This position will develop and author laboratory Standard Operating Procedures (SOPs), methods, protocols, and reports. Support work related to production, R&D and NDA/ANDA filings. This position will be responsible for laboratory instrument troubleshooting and routine maintenance to ensure they are in compliance with established procedures and cGMPs requirements. This position will maintain accuracy in laboratory operations, scientific data, and notebook writing as well as responsible for review, interpretation, compilation of results and preparing scientific reports.
- Act as analytical lead and work with the cross-functional team on new projects.
- Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
- Ensure high quality in analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
- Develop / improve and validate robust analytical methods that are GMP friendly and document formal protocols and reports.
- Lead analytical method transfers to third party contract organizations.
- Propose specifications and provide justification for analytical methods and specifications.
- Review experimental data, notebooks and instrument qualification protocols / reports.
- Actively participate in investigations, problem solving and troubleshooting. Write investigation reports.
- Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
- Write, revise, develop and evaluate SOPs.
- Operate and maintain all analytical instrumentation and equipment as per established procedures.
- Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
- Provide coaching to junior staff members.
- Maintain good laboratory practices in compliance with safety and environmental requirements.
- Ability to work successfully in both a team/matrix environment as well as independently.
Education and Experience:
- BS with 15+ years or MS with 10+ years or PhD with 5+ years of relevant experience in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry
Necessary Knowledge, Skills and Abilities:
- Demonstrated sound knowledge of analytical chemistry, separation sciences, spectroscopy, and a variety of hands-on analytical techniques.
- Thorough understanding and working knowledge of industry guidance (GMP, GLP, etc.).
- Extensive experience in pharmaceutical method development, validation and transfer.
- Understanding of risks in all aspects of method development, validation and transfer and the ability to use risk analysis and quality-by-design approaches.
- Ability to lead problem solving and trouble shooting.
- Skillful in HPLC, GC, dissolution, FTIR, UV, LC/MS, KF and wet chemistry.
- Knowledge of Waters Empower chromatography software and Waters online HPLC Automated Dissolution.
- Prior experience in finished dosage for the generic market.
Supervisory Responsibilities (if applicable):
There are no direct reports for this position. However, this role will require the ability to coach junior colleagues in regulatory, project management and technical transfer.
Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: email@example.com.
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- Job Family Research & Development
- Pay Type Salary
- Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island, United States of America