As 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.

Key Responsibilities:

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:

• BS in a scientific discipline + a minimum of 12 years of experience in a biopharm development and/or manufacturing role
• Experience in development and characterization of cell culture processes for biopharmaceutical production
• Experience in small-scale model development/qualification and principles for successful process scale-up
• Experience in technology transfer to clinical and/or commercial manufacturing sites
• Experience authoring CMC sections of regulatory filings
• Experience with current QbD approaches and control strategy development
• Experience leading technical teams

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

Preferred Qualifications:

• 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
• Experience with chemically-defined media/feed development for intensified processes
• Excellent communication and teamwork skills

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.