Formulator

Piping Rock•Aurora, OH

1d•$95,000 - $96,500•Onsite

About The Position

The Formulator is responsible for all aspects of product formulation, product/process development, scale up and commercialization of dietary supplement dosage forms. This role explores and conducts research in relevant technologies for product innovation and product/processes enhancement.

Requirements

Master's degree in Pharmaceutical Science or related science with minimum of 1 years of relevant experience.
Requires 1 year of experience performing pre-formulation assessment and developing formulations using Fette Compacting, Kikusui, Manesty & Stokes, Vanguard compression equipment, Bosch, Vanguard, Zanasi, NPJ encapsulation equipment.
Also requires 1 year of experience ensuring compliance with 21 CFR Part 111 Current Good Manufacturing Practice (CGMP) requirements
Excellent written and verbal communication and interpersonal skills with the ability to communicate effectively with multiple levels within the organization
Project management skills.
Creative/Innovative: develop new and unique ways to improve operations of the organization.
Organize: Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
Plan: determine strategies to move the organization forward, set goals, create and implement action plans, and evaluate the process and results.
Solve Problems: Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem.
Comprehensive knowledge and practical experience with product/process development, processing laboratory techniques and regulatory requirements and a foundation in chemistry, mathematics, pharmaceutics and/or food science.
Strong critical thinking and problem-solving skills.
Must comply with GMP requirements; specific functions and documents will be discussed in GMP and on the job training

Responsibilities

Assist in developing robust formulations and processes for new immediate release and modified release tablet and capsule dosage forms and powder products.
Ensure that all internal and external work activities are conducted to appropriate standards, in accordance with Company policies, laws, quality standards, SOPs, etc.
Conduct scientific experiments to create prototype products.
Responsible for qualification/verification/validation reports.
Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
Interaction with raw material manufacturers and other vendors as needed.
Evaluate raw material for pre-formulation assessment to ensure compliance to regulatory requirements
Prepare appropriate documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
Maintains all project-related historical documentation, project schedules, and milestone due dates
Prepare batch records, process characterization reports, verification reports and investigation reports.
Additional duties as assigned