Primary Objective of Position
• This position’s key function is to support Product Development by conducting research directed toward development of new formulations and/or formulation platforms for a significant PD project or a number of small projects with many complex features under minimal supervision using established and novel technology.
• Responsible for the formulation development and evaluation of complex pharmaceutical products such as controlled release solid oral dosage forms, liquids, or parenterals.
• Performs in depth, detailed and complex literature and patent searches to provide background basis for development plans.
• Plans, executes, and assists in the evaluation of formulation development, scale-up and process transfer activities. May lead initiatives within the Product Development group.
• Partners with Department Director and other research experts to develop new concepts. Assists in the development of project plans and business analysis and feasibility assessments.
• Writes, reviews, and approves cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.
• Insures training for self and other PD personnel, as requested. May identify and develop specific training content to support ongoing development efforts. Will train less senior Scientists.
• Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.
• Maintains and expands knowledge of current and new formulation development technologies and manufacturing processes (ours and competitive).
• Advances process technologies and supports the patent (intellectual property) development.
• Provides mentoring to less senior Scientists.
Leads work of others who perform essentially the same work. May organize, set priorities, schedule and review work, but has no responsibility to hire, terminate, review performance or make pay decisions.
Minimum Job Qualifications
PhD in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering or similar is required.
Eight (8)+ years of relevant work experience in pharmaceutical product development.
Three (3)+ years of experience with oversight of a technical team required.
Hands-on experience with pharmaceutical formulation development using QbD principles is required.
• In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.
• Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.
• Proven experience with statistical design of experiments.
• Strong written and oral communication skills.
• Working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regards to IIG, GRAS, residual solvents, bioequivalence studies, etc for oral formulations.
• Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent.
• Ability to assist in preparing presentations, speeches, and articles for publication that conform to prescribed style and format.
• Ability to present technical presentations to management or research teams to ensure understanding, responding to complex questions.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described her are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk, sit, climb or balance and stoop, kneel, crouch or crawl. The employee is occasionally required to use hands to handle or feel.
The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, and occasionally lift and/or move more than 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; read and interpret data, information and documents; analyze and solve non-routine office administrative problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information skills; perform detailed work on multiple, concurrent tasks; work under deadlines with frequent interruptions; and interact with the department staff and others outside the department.
The employee works under typical office conditions. The noise level in the work environment is usually quiet to moderate.