The Formulation Scientist I to II would be helping formulation development of generic and branded prescription products in injectable, ophthalmic, and/or respiratory dosage forms. These dosage forms should be developed as per the FDA's latest QbD guidelines for submission of ANDAs and/or NDAs. The scientist will be working in a highly collaborative and motivating environment.
Responsibilities and Duties
- Help develop drug formulations based on sound scientific principles
- Help in reverse engineering of branded and other marketed products (Q1/Q2/Q3 evaluations)
- Help in selection and procurement of packaging components
- Help in literature search, as needed.
- Submit stability samples to ADL and compile stability data.
- Understand the impact of various formulation parameters and suggest additional experiments, as needed.
- Help optimize lab formulations based on stability studies.
- Help scale-up formulations from lab to pilot plant to commercial quantities, as needed
- Help in evaluation and procurement of laboratory equipment, pilot plant, and commercial equipment as needed
- Manufacture R&D, Clinical and Exhibit batches
- Develop product specifications for in-process, release, and stability
- Work closely with Analytical Research to reverse engineer and formulate generic and/or innovative products
- Maintain a high level of quality and regulatory compliance
Qualifications and Skills
B.S./Master's in chemistry, chemical engineering, or pharmaceutical sciences
- Bachelor's or Master's degree with 0 - 5 years. hands-on experience in product development of generic or branded injectable and/or ophthalmic drugs.
- Working knowledge of Word, PowerPoint, and Excel software.
- Participate in a comprehensive benefits package, including Health, Dental, Vision, Life Insurance, Short-term/Long Term Disability and participate in matching 401(k) plans