Catalent Pharma Solutions Principal Scientist in Somerset, New Jersey
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Works on highly complex problems where analysis requires evaluation of factors of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria. Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Considered an internal leader in his/her technical field.
- Conducts AR&D activities required for the timely completion of feasibility studies for new pharmaceutical products including: solubility and suspension studies, particles size and sedimentation studies, temperature cycling studies, excipient and gel compatibility studies, accelerated kinetic studies/
- Carry out AR&D studies resulting in successful timely pilot scale manufacture of new pharmaceutical products including: accompany customers in monitoring their pilot batches, prepare pilot batch documentation, ensure availability of raw materials, supervise pilot batch manufacture, ensure that pilot batch is manufactured under cGMP's, carry out and monitor in-process controls and drying studies, complete batch documentation.
- Oversee and assure the successful timely scale-up and transfer of Analytical Methods, in to and out of AR&D Somerset.
- Interpret, evaluate, communicate and properly document the results of development work and make recommendations for action.
- Serve as primary scientific liaison with the customer on assigned projects.
- Be an effective Project Leader for designated projects.
- Together with supervision, determine general development approaches to be utilized for assigned projects, then plans and executes development work independently with minimal supervision.
- Coordinate with AR&D, Pilot Plant, QC, QA, and other groups, activities necessary to ensure project requirements are met.
- Prepare CMC sections, technical and verbal reports and presentations on project progress as well as specifications, procedures, and SOPs.
- Assist in the training, development, and evaluation of any R&D personnel whose work he/she directs.
- Keep abreast of scientific literature which may have relevance to PTSC technologies.
- Performs other miscellaneous technical and administrative duties are required to meet company objectives.
- Comply with Health, Safety, and Environmental responsibilities for the position
- Other tasks as assigned.
Education: * PhD in Pharmaceutics/Chemistry or related science or MS with equivalent experience.
Experience: * 10-12 years experience in AR&D focused on Drug Products and Drug Substances.
Knowledge/Skills: * Expert knowledge in scientific principles and concepts. Experience in Analytical Research and Development, on pharmaceutical compositions preferred. Exposure to computer software associated with word processing and spreadsheets desirable.
Supervises: * May direct the work of other AR&D personnel as assigned.
PHYSICAL/MENTAL REQUIREMENTS: * Mathematical and reasoning ability. * Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. * Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly, and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
WORK ENVIORNMENT: * Individual's primary workstation is located in the office area as well as the laboratory area, where the noise level is low.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Organization: Drug Delivery Solutions (DDS)
Title: Principal Scientist
Requisition ID: 0020388