Compounding Specialist

6 days ago

Albany, New York, United States Wedgewood Pharmacy Full time

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 product.
  • 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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