Sr. Specialist, Engineering

Job Description

Sr Specialist, Engineering, HPV Drug Substance Fermentation

Job Description

Large Molecule Science and Technology (LMS&T) HPV Vaccine Technical Product Leadership (TPL) is seeking a highly motivated person for the role of Senior Specialist, Engineering, in the Vaccine Technical Product Leadership group. This role will provide manufacturing science and technology support across the HPV vaccine sites with a focus on drug substance fermentation.  The manufacturing sites include: Elkton- VA; West Point-PA and Durham, NC.  

HPV Technical Product Leadership is a customer-focused Above-Site technical support group with the primary focus to partner with key business units and customers to identify and implement innovative technical solutions and operational improvements that promote both process and supply chain robustness across the lifecycle of the product. The Senior Specialist, Engineer, Vaccine Technical Product Leadership will partner with groups across the Company, including Technical Operations, Operations, Quality, commercialization, process development, Regulatory-CMC, Supply Chain, and Value Chain.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Coordinate technical teams across the network to achieve HPV Vaccine strategic goals

• Participate as a technical expert and/or as a project leader in various projects

• Ensure Process and Assay Robustness for the HPV manufacturing network through Process Monitoring, and/or engaging with site technical teams to identify potential issues/causes and drive rapid resolution

• Apply vaccine product/manufacturing process Subject Matter Expertise to plan and lead complex multi-site investigations and drive proactive process improvement projects.

• Provide on-site support for critical HPV vaccine site investigations and specialized technical requests

• Collaborate and engage with key functional leads within LMS&T, site manufacturing, commercialization, our Research & Development Division and process development/support laboratories to identify and implement opportunities for process improvement and enhanced process robustness

• Build and maintain strong and trusting relationships with site counterparts, functional management, and other stakeholders to ensure effective communication of plans and issues

• Support Technology Transfer activities within the HPV manufacturing network

Education Minimum Requirement:  

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, or related field with six (6) years of relevant experience; or M.S. with four (4) years of relevant experience; or Ph.D. with one (1) year of relevant experience

Required Experience and Skills:

• Demonstrated problem solving, effective verbal and written communication, and strong interpersonal skills

• Strong scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements

• Collaborate effectively, across functional boundaries, to align or influence stakeholders and sponsors to provide technical solutions

• Demonstrated leadership and ability to drive results

• Ability to work independently to drive projects to completion

• Ability to travel up to 25% depending upon critical project and site needs

Preferred Experience and Skills:

• Minimum 3 years direct experience in vaccine or biologics Drug Substance process development, commercialization, or manufacturing

• Experience authoring technical documentation

• Experience managing project teams

• Knowledge and experience with data/statistical analysis

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benef