• MS in Engineering/Science emphasis on mechanical, chemistry or pharmaceutical with 5 years of experience in the pharmaceutical, biotech or medical device industry.
• Technical experience in liquid/semi solid process development, scale up and technology transfer
• Working knowledge of cGMP and FDA guidelines
• Overall strong experience in product development, lab scale and pilot scale manufacturing
• Proven experience in manufacturing process technology transfer
• Proven experience in authoring or reviewing and approving manufacturing process development related sections of regulatory submissions
• Demonstrated interpersonal skills to work effectively with cross-functional and cross-cultural teams in multiple locations both within and external to the company
• Evidence of delivering projects to tight timelines and ability to drive multiple projects at one time
• Candidate will be located at the Upper Providence site in PA and travel to other sites if required
• Approximately 0-10% percent domestic and/or international travel
• Ph.D. in Engineering/Science with at least 2 years of experience
• Proven experience in formulation development with specific expertise in the development of topical formulations and manufacturing processes
This role will be accountable for manufacturing process development for novel topical drug products. This includes scale-up and technology transfer to the commercial manufacturing site as well as the manufacture of safety assessment and clinical trial supplies at internal or external manufacturing sites. This person will partner with other functional areas to deliver GSK's vision to be the global leader in science-based, innovative products for dermatology. This role is a direct report to the Team Leader, Topical Product Development and is based in Upper Providence, PA. This role will require significant cross-functional interactions in a highly matrixed, project centric organization.
• Utilize multivariate Design of Experiments to develop and optimize manufacturing processes for novel topical medicines
• Plan, coordinate and perform activities for lab-scale and pilot-scale batch manufacture
• Create process development protocols, batch records and manufacturing plans when needed
• Generate master formulation sheets and raw material specifications
• Conduct and execute manufacturing scale-up studies using pilot- and commercial-scale equipment
• Participate in the preparation of safety assessment and clinical trial supplies in accordance with GMP regulations
• Work closely with Global Manufacturing New Product Introduction team to transfer novel topical products and their associated manufacturing processes to the commercial manufacturing site
• Author manufacturing process development related sections of regulatory submissions
• Provide subject matter expertise in topical process development where assigned
• Provide regular updates to line management and create development reports which will become the foundation of the pharmaceutical development report for CMC regulatory submission
• Ensure that GSK expectations regarding training, compliance, quality, safety and production are clearly documented and consistently met
You may apply for this position online by selecting the Apply now button.
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