Pharmaceutical Formulation Expert
6 days ago
About the Role:
The Product Development Specialist plays a critical role in supporting the development of new pharmaceutical products at Wedgewood Pharmacy. This position requires a strong technical background in formulation and analytical chemistry, as well as excellent communication and collaboration skills.
Key Responsibilities:
- Collaborate with Operations to develop new formulations that meet the clinical needs of customers.
- Create and manage change controls for preparations.
- Respond to and support change controls generated by the organization which may affect finished product stability.
- Document detailed product information into systems for use in technical services, customer services, materials management, manufacturing, and marketing.
- Design and oversee product stability studies and generate final reports.
- Lead investigations into deviations and identification and implementation of corrective actions related to product development.
- Evaluate, change, and test current formulas through annual product reviews, quality requests, or patient feedback.
- Coordinate and assist with feasibility studies.
- Monitor and report study progress/status on a site level.
- Act as a point of contact to both corporate and director level individuals regarding product stability projects.
- Develop and draft new product stability protocols with minimal supervision.
- Assist in drafting R&D protocols and summary reports as needed.
- Oversee and ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities.
- Responsible for performing investigations related to OOS laboratory testing.
- Responsible for executing research and test method development projects for established and new products.
Requirements:
- Familiarity with regulatory guidelines, specifically 21 CFR 210 & 211, USP 795, 797 & 800, ICH Q1AR2 and Q1D and 503B Guidance.
- Highly skilled in performing chemistry analysis related to stability studies, needing little or no guidance, including tracking and trending of data.
- Detail-oriented and understands the importance of accuracy and responsiveness.
- Positive, professional attitude.
- An excellent oral & written communicator with whom teammates and customers love to work.
- Experience in formulation of pharmaceutical products.
- Designed and performed product characterization/optimization experiments to identify critical process parameters.
- A Bachelor's degree, or equivalent in the sciences or related discipline is required.
What We Offer:
- A comprehensive benefits package that includes health, dental, and flexible spending accounts.
- 401(k) retirement plan with a generous company contribution to help you save for the future.
- Company Paid Life and disability insurance.
- Access to voluntary insurance options.
- A generous paid time off program that increases every year.
- Tuition reimbursement.
- Opportunity for growth - We believe in promoting from within and do so through our internal job posting program.
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