AR&D IVRT SCIENTIST - 190000159
Who We Are
Cosette Pharmaceuticals, Inc. is a generic pharmaceutical company specializing in the areas of dermatology and allergy, with products available in dosage forms such as creams, ointments, lotions, solutions, gels, pastes and suppositories. The company was formed when Avista Capital Partners, a leading private equity firm focused on growth-oriented healthcare businesses, purchased the extended topicals and dermatology portfolio of G&W Laboratories in December 2018. As Cosette Pharma begins creating its own future, the company plans to build upon the 100+ year history of the organization by continuing to provide a wide range of high-quality medications, a robust supply chain, and a customer-centric philosophy of how we conduct business. By doing so, Cosette Pharma will be able to meet the needs of customers, and ultimately, help patients treat their conditions.
The company is headquartered in South Plainfield, NJ. The site contains a manufacturing facility, an R&D laboratory and offices.
Why Cosette Pharmaceuticals
Cosette Pharmaceuticals, Inc. is a fully integrated generic pharmaceutical company with end-to-end capabilities in Product Development, Manufacturing and Commercial Operations. We sell products to all classes of trade within the US supply chain, including drug wholesalers and distributors, retail chains, food stores, mass merchandisers, mail order pharmacies, acute care and long-term care pharmacies, and retail/acute care GPOs. The current product offering spans a wide range of presentations, with a focus on creams, ointments, liquids/solutions and suppositories. With well-established R&D and Business Development functions, Cosette Pharma is expanding our product offering by bringing new products to market via internal development and external licensing or acquisitions. While staying true to our therapeutic history, Cosette Pharma is expanding into adjacent areas. This will allow Cosette Pharma to leverage our considerable operating and commercial infrastructure, including 200+ dedicated employees across all functional areas.
Responsible for Development, and validation of IVRT analytical methods. Responsible to plan and conduct the Pilot / Pivotal IVRT studies.
- Independently manage analytical methods development and validation of IVRT methods for New topical semisolid drug Products
- Compare the in-vitro release rate of drug substance from formulations for SUPAC changes.
- Technically supervise and coach junior chemists in IVRT related activities
- Write/ review the IVRT method development, method validation reports
- Write/ review IVRT (Pilot / Pivotal) study protocols and reports
- Knowledge of FDA guidelines relevant to IVRT method development, method validation and Pilot/Pivotal studies requirements
- Should have some understanding of the guidance and requirements of IVPT
- Some hands on experience with the IVPT is preferable
- Reverse engineer reference listed drug products using various analytical techniques.
- Perform methods development and validation using analytical techniques such as HPLCs/UPLCs, GC, UV, Dissolution, TLC, FT-IR, and Particle Size Analyzers, Rheology. for
- API, Related Substances, Residual Solvents in drug substances
- API, Preservatives and related degradation products
- Leachables and extractables
- Particle Size Analysis of API, Excipients and Drug Products
- Develop / Validate dissolution methods, where applicable
- Maintain proper laboratory notebooks and prepare AR&D reports.
- Write test methods, method validation protocols and reports.
- Issue regular update reports on progress of projects.
- Perform routine maintenance and calibration of laboratory instruments.
- Conduct literature searches for assigned projects.
- Conduct several simultaneous projects. Develop project timelines.
- Perform other duties as assigned.
- Comply with standard operating procedure & current Good manufacturing practices (cGMP).
Aspects of Performance:
¨ Maintains confidentiality
¨ Possesses sound analytical problem-solving and documentation skills
¨ Communicates effectively
¨ Demonstrates ability to prioritize conflicting demands
¨ Executes assigned tasks within established schedule
¨ Writes and speaks clearly and concisely
¨ Develop and maintain expertise in chemistry/pharmaceutics through continuing professional education and training
¨ Comply with Company policies, procedures, rules and regulations
Bachelor’s / Master’s degree or Ph.D. in Chemistry or Pharmacy.
Relevant IVPT experience is necessary for this position. Additional analytical R&D experience is preferable.
2-3 years of relevant experience of IVPT/IVRT required with a Ph.D.
3-5 years of relevant experience of IVPT/IVRT is required with a Master’s degree
6-8 years of relevant experience of IVPT/IVRT is required with a Bachelor’s degree.
Equal Opportunity Employment
Providing “equal employment opportunity” is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.
Job-Research & Development
Job Posting-Oct 21, 2019