Scientific Director, Upstream Process Development

As Scientific Director, Upstream Process Development within Biopharm Drug Substance Development, you will provide strategic leadership of scientific and organizational objectives related to portfolio projects and technology initiatives.

You’ll have the opportunity to initiate departmental scientific or technology programs and/or external interactions to support anticipated department needs and contribute to strategic planning for the direction of the department and the wider DSD and MDS organizations. 

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead and develop a team of scientists and scientific leaders responsible for development, characterization, scale-up, and tech transfer of late-phase cell culture processes for biopharmaceutical production.

• Critically review technical reports, protocols, technology transfer documents, and CMC sections of regulatory filings.

• Lead and/or contribute to on-going technology development efforts within the department, potentially including development of proprietary cell culture media and feed formulations, improving the efficiency and productivity of platform processes, and the application of process analytical technologies (PAT).

• Lead and/or contribute to technical due diligence evaluations of business development opportunities.

• Effectively prioritize team and departmental goals, adapting plans and resources in response to evolving needs to deliver required business objectives.

• Ensure appropriate scientific / peer review practices are in place throughout the development lifecycle, including prospective interrogation of plans ensuring delivery aligned to governance expectations.

• Facilitate mitigation and/or escalation of risks identified throughout the product lifecycle as appropriate.

• Contribute to scientific/technical decision making on programs/projects.

• Contribute to the development of departmental strategies and policies.

• Communicate and share knowledge effectively across departments/divisions.

• Actively promote the effective use and reuse of institutional knowledge advocating for a “Predict, Design, then Execute“ mindset by first intent to ensure efficient use of R&D resource.

• Exhibit strong focus on assurance of data integrity standards aligned to ALCOA+ principles. 

• Proactively implement and reinforce safe working practices through suitable training, gemba, and continuous improvement initiatives.

• Demonstrate leadership in the creation and development of a high-performance culture.

• Accurately assess performance and support development needs of team members through formal appraisal.

• Act as a delegate for the department’s Senior Director to review/approve controlled documents and other duties as appropriate.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS in a scientific discipline.

• 12 + years in a biopharm process development role.

• Development and characterization of cell culture processes for biopharmaceutical production.

• Control strategy development.

• Cell culture process scale up and technology transfer experience.

• Authoring CMC sections for regulatory filings.

• Leading teams of process development scientists.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Ph.D. in a relevant scientific discipline + a minimum of 7 years of experience in a biopharm development and/or manufacturing role.

• Experience authoring and/or reviewing BLA/MAA drug substance modules.

• Experience collaborating with CDMOs for process development and/or manufacturing.

#LI-GSK

Why GSK?

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the imm