Formulation Specialist 97443
Job Description:
o Develops solid dosage formulations.
o Designs and conducts laboratory research and development experimentation focused on formulation/process development, optimization, technology transfer and implementation at the production scale.
o Coordinates activities of contracted formulation development, clinical supplies manufacturing, and stability studies.
o Designs and conducts experimentation focused on development of cGMP processes that are suitable for validation.
o Scale-up and transfers cGMP manufacturing processes for all stages of the project: from early phase clinical trials to commercial product.
o Reviews the CMO manufacturing/packaging batch records, process diagrams, validation protocols and reports.
o Participates in the selection of manufacturing equipment and facilities.
o Participates in the problem solving of formulation and scale-up issues during implementation of processes at the manufacturing site.
o Designs and conducts experiments to characterize properties of API and Drug Products.
o Develops physical characterization test methods of API and DP for transfer to and use by QC.
o Evaluates external novel particle engineering technologies.
o Contributes to the development of specifications of raw materials, drug product and packaging components.
o Works closely with internal technical groups (Pharmaceutics, Chemistry, Analytical, Quality, Regulatory Affairs) project team.
o Supports CMC related activities for regulatory submissions by writing CMC sections.
o Applies Pharmaceutical Engineering and material science principles to evaluate new drug product candidates for robustness/scalability and manufacturability beyond lab/pilot scale demos.
o Identifies and introduces new technology and tools (PAT, QbD) into development or commercialized product applications for aerosol and solid dosage forms.
o Displays the leadership, managerial and technical skills necessary to lead a project team conducting research and development with limited supervision.
Essential Functions Required for Job:
o Demonstrated knowledge of batch process modeling and optimization for key unit operations used in the manufacturing of solid and solution drug products.
o Familiarity of Active Pharmaceutical Ingredient characterization and API-excipient compatibility.
o Advanced mathematical and statistical skills with demonstrated applied use in the areas of design of experiments and general complex data efficient reduction to practice.
o Must have the ability to set priorities and lead projects with limited resources and even imprecise information.
o Demonstrated ability in cGMP's and current FDA guidance to contribute to the regulatory success of developmental activities.
o Familiarity with pre-approval inspection and post-approval change process and guidelines.
o Working knowledge of pharmaceutical science, industrial pharmacy and also modern material science and analytical methods.
o Excellent verbal and written communication skills are essential.
o Prepares reports and maintains documentation of development results and activities.
Other requirements
o Ability to work effectively with multidisciplinary teams (chemistry, formulation, engineering and regulatory) is essential.
Compliance
o Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of COMPANY are carried out with the best industry practices and the highest ethical standards.
Mental/Physical Requirements
o Fast-paced environment requires handling multiple demands.
o Must be able to exercise appropriate judgment, as necessary.
o Requires a high level of initiative and independence.
o Excellent written and oral communication skills required.
o Requires ability to use a personal computer for extended periods of time.
Education:
o Masters Degree
o Advanced degree in Pharmaceutical Science and Engineering, or Industrial Pharmacy, or Chemical Engineering or Material Science and Engineering
o (MS with 7
years or Ph.D. with 4
years of relevant experience)Estimated Salary: $20 to $28 per hour based on qualifications.
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