Technical Lab Services Leader, Process Engineering & Modeling

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs.  With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Technical Lab Services Leader, Process Engineering & Modeling

Location(s)

GSK (Collegeville) - Customer Site PA

Job Responsibilities:

Process Engineering:

• Conduct laboratory experimentation and analytical testing of putative formulations & drug product manufacturing
• Follow administration/delivery approaches for select protein therapeutic assets, including  contributing to, the conception & evaluation of conventional & novel product matrices and administration modalities
• Partner closely with the manufacturing groups during process development and technology transfers
• Actively participate with combination drug product assessment and collaborate with device engineering
• Physicochemical and bioanalytical characterization of native and modified biopharma compounds
• Collaborate with the Bioanalytical Sciences group to develop & transfer stability-indicating analytical methods for use in product development
• Oversee release & stability testing; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
• Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols
• Assess resultant data; working closely with internal & external discovery and development support partners as needed
• Develop and implement chemometric process models to support process monitoring and control activities during pilot scale and commercial manufacturing.

Modeling:

• Establish Hybrid/mechanistic process models to accelerate development, increase fundamental understanding, improve risk assessment and deliver more robust processes, products and regulatory filings.
• Implement modelling and simulation directly on key projects to increase fundamental understanding and greatly reduce labor, materials and time required to identify commercial processes.
• Upskill project team members to expand the use of simulation and work with internal and external experts to development /maintain core simulation software platforms.
• Champion integration of new ways of working into existing QbD workflows (e.g. Process Design, Control Strategy Identification, Risk Assessment), regulatory filing strategies and life cycle planning.
• Provide or coordinate training and real-time support to expand the use of chemometrics and mechanistic modeling (simulation) across business modalities.
• Stay current with new modeling techniques through publications, conferences and academic and precompetitive collaborations
• Advocate and comply with GMP requirements for recording experiments and associated data and writing modeling sports including scientific review and data checking.
•  Adhere to requirements of Good Manufacturing Practice, Safety, Quality for the Patient and GSK policies and procedures (sites and department).
• Provide critical support outside area of expertise if required to make sure projects meet development timelines.

Leadership:

• Mentor and train staff at client location regarding best-in-class customer support, follow up communication and specific laboratory support skills to drive growth and customer satisfaction
• Collaborate with Service Manager to drive talent development,