Senior Scientist/Engineer - Topical Process Development
• BS in Engineering/Science emphasis on mechanical, chemistry or pharmaceutical with 5 years of experience in the pharmaceutical, biotech or medical device industry or 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
• 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
• MS in Engineering/Science with at least 2 years of experience
• Proven experience in formulation development/optimization and process development/optimization, with specific expertise in the development of topical formulations and manufacturing processes
• Proven experience in utilizing QbD approaches to ensure robust and reliable products and manufacturing processes
• Proven experience in authoring or reviewing and approving manufacturing process development related sections of regulatory submissions
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
Back to top