Job SummaryThis position working in the CMC team is responsible for drug development activities related to formulation design of new prescription drug products. The role will also cover other stages of drug development such as process design, optimization and scale up of the manufacturing processes, and manufacture of clinical trial materials in support of clinical studies and regulatory submissions. Work is performed in a virtual pharmaceutical development setting in cooperation with contract manufacturing organizations.Essential Duties and Responsibilities· Lead formulation and process development studies, process optimization and scale-up, process validation, and cGMP manufacturing at various contract development and / or manufacturing sites· Review and approve GMP documents (e.g., MBRs, SOPs, RM specifications, protocols)· Closely interact with contract manufacturers for drug product formulation and development· Work in the CMC team and other cross-functional teams to ensure development of the drug products in a timely, compliant, and cost effective manner· Support and enable CMC regulatory filings· Responsible for execution of commercial product support projects in the areas of product technical transfer, troubleshooting and investigation· Implementation of key elements of quality by designOther DutiesOther duties, responsibilities and activities may be assigned.QualificationsRequired Qualifications:· M.S in pharmaceutical science or related scientific discipline with 3+ years pharmaceutical drug product formulation experience or BS degree with extensive industry experience (5+ years)· Experience with oral solid dosage form and topical dosage form product development and manufacturing· Experience with process scale-up and clinical manufacturing· Experience in drug product IND/NDA regulatory filing· Experience in managing CROs/CMOs for drug product formulation development and manufacturing· Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy· Strong interpersonal skills, ability to communicate clearly, concisely, and effectively in both written and oral contextPreferred Qualifications· Pharmaceutical product formulation and process development· Familiarity and hands on experience with quality by design in drug product development· Knowledge and experience with analytical method development· Flexibility in problem solving including the ability to independently devise and implement practical solutions to resolve complex issues in a virtual environment, providing direction and work hours to meet business objectives· Ability to effectively assess project timelines and assess resource requirements and provide recommendations to management· Proficiency in analysis of data using statistical evaluation· Project management skillsEducationRequired Education: BS degree in pharmaceutical science or related scientific discipline (with extensive industry experience, 5+ years).Preferred Education:M.S in pharmaceutical science or related scientific discipline (with 3+ years pharmaceutical drug product formulation experience).Physical functions· This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Some of the work will require exposure to loud noises or fumes in a manufacturing plant environment.· The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 35 pounds.· Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.Work Environment· This job routinely operates in a professional office environment.· On occasion work may be performed in a pharmaceutical product manufacturing or laboratory setting.TravelThis position may require up to 30% travel. Requires travel out of the area and overnight.Direct reports (When Applicable)N/A
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