What are the responsibilities and job description for the Product Development Specialist position at Wedgewood?
Great Care, Delivered is the promise that we make to our customers. If you have a passion for helping animals, and a love for serving others - we want you to help us deliver on that promise by joining our Quality Team.
The Product Development Specialist contributes technical expertise to support efforts in product development, including drug formulation and analytical chemistry. This position provides clinical and technical services to the Quality department and ensures that all responsibilities will be performed in accordance with all relevant state and federal regulations. This position reports to our Quality Director.
When will you work?
- The hours for this position are Monday – Friday in our Albany, Ohio facility.
What you’ll do:
- Work in collaboration with Operations to develop new formulations that meet the clinical needs of our 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, compounding, and marketing.
- Design stability studies, protocols, and generate final reports.
- Leads investigation into deviations and identification and implementation of corrective actions related to product development.
- Evaluate, change, and test current formulas based on annualized product reviews, quality requests, or patient feedback.
- Reviews and helps assemble Annual Product Reviews.
- Coordinates and assists with feasibility studies.
- Monitors and reports study progress/status on a site level.
- Act as a point of contact to both corporate and director level individuals regarding R&D projects.
- Develop and draft new product protocols or formula ID’s with minimal supervision.
- Assist in drafting Product Development protocols and summary reports.
- Oversee and ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA)
- Responsible for designing and performing different bench studies for Research & Development as needed.
- Responsible for performing investigations related to OOS laboratory testing.
- Responsible for executing research and test method development projects for established and new products.
Who you are:
- 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
What you’ve done:
- 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’s in it for you:
- 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!
About Us
Wedgewood is the nation’s largest and most trusted provider of compounded veterinary medications. Its recent merger with Blue Rabbit enables the company to provide veterinarians with next-generation software to streamline patient care and marks a significant evolution in services. Together Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and one million animals annually.
Wedgewood is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.
