This critical position will be responsible for the successful development of robust formulae and processing of selected products from laboratory batches through scale up and commercialization.
Identify the Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes and Critical Process Parameters to arrive at robust formulation strategy.
Develop stable product formulations that meet or exceed requirements within specified timelines.
Conduct process optimization studies and arrive at control strategy.
Work with Biopharmaceutics and analytical teams to design predictive in vitro methods. Ensure bio-batch samples are successfully delivered to CRO and coordinate activities with the clinical team for timely start of bio-study
Travel to CMO (internal DRL sites or external) for the execution of pilot bio-batches, scale up batches and exhibit batches (registration batches).
Collate data generated from previous stages and prepare the Pharmaceutical Development Reports for submittal to Regulatory Affairs for filing. Respond to deficiencies/queries from the regulatory agencies with further data or clarifications to obtain approvals in shortest possible time.
BS in Pharmaceutical sciences / technology with 5 years of relevant work experience; M.S. in Chemistry 3 - 6 years of generic analytical formulation experience in a pharmaceutical environment highly preferred.
Experience in developing extended release products and handling controlled substances is a plus.
Knowledge of pre-formulation, manufacturing technology and scale-up as well as FDA & DEA regulations.
Good communication (written & verbal), interpersonal, and organization skills
Good computer skills including experience with MS Office Suite
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.