Purpose and Scope
Manages the development of appropriate assays for testing and release of pharmaceutical products, raw materials, and stability samples. Has proven track record in the analytical development of specialty injectable products by gaining FDA approval of microsphere, liposome, or nanoparticle parenteral delivery systems. Provide management oversight and leadership to the Analytical Development laboratory staff.
Essential Duties & Responsibilities
Develop analytical methods to support multiple projects at different phases of maturity.
Evaluate analytical data for validity.
Manage testing of pharmaceutical products, raw materials, stability samples.
Review and report analyses conducted against established specifications.
Work with multiple project team members to facilitate the analytical development of viable products.
Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate.
Review and approve technical reports, test methods and procedural documents.
Manage departmental spending to stay within the established budget.
Ensure GLP and GMP compliance of laboratory.
Participate in audits (as needed) and directly interact with potential marketing partners and regulatory agencies.
Manage the creation of regulatory documents for FDA submissions.
Perform other related duties as assigned.
Knowledge, Skills & Abilities
Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
Supervisory experience with exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the department as a whole.
Good understanding of regulatory guidelines.
Working knowledge of general accounting procedures.
Excellent skill in effective oral and written communication.
Ability to prepare, review, conduct, develop and/or validate analytical methods and product specifications.
Ability to coordinate activities to assure customer needs and project goals are met.
Strong ability to operate analytical instrumentation.
Ability to logically troubleshoot instrument problems and product issues.
Ability to lead a team of analytical professionals that is fully compliant with current Good Laboratory Practices and Good Manufacturing Practices.
Experience in the development of specialty injectable pharmaceutical products.
Bachelor’s degree in chemistry or a related discipline.
Eight or more years of related industry experience with a minimum of two year’s supervisory experience.
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