Director Process Development Jobs in Pennsylvania

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
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Our approach to R&D
Position Summary
You will lead sterile process engineering activities to support development and commercial supply of sterile drug products. You will work across formulation, analytics, manufacturing and external partners to design, scale and transfer robust sterile processes. We value clear problem solvers who build strong working relationships. This role offers technical growth, broad impact on patient-focused products, and the chance to work with experienced teams who unite science, technology and talent to get ahead of disease together.
Key responsibilities include:

• Work as drug product (DP) process engineering and analytics (PE&A) lead in a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) Scientists, automation experts, data scientists and device engineers, to deliver the work packages required to understand DP unit operations and scale these-up effectively.
• Provide expertise in process development, characterization, scale -up, technology transfer, and modelling, to deliver processes for sterile products (small molecule suspensions, ADC or Biopharm drug product) that are well understood.
• Identify use-cases where in silico tools can speed up DP development, then work with modelling and development teams to design, validate and deploy those solutions. Actively participate in technical reviews on projects, lead the technical transfer of processes, prepare functional project plans, and ensure timely execution.
• Contribute to CMC team planning and objective setting, agreeing priorities and coordinating PE&A activities that support delivery of objectives.
• Ensure proper Process Engineering decisions are taken at appropriate milestones within the DP project plan to accelerate early phase formulation and process design and minimize number of DOEs for scalability assessments and API consumption throughout the DP development life-cycle.
• Author sections of regulatory documents relevant to Process Engineering platforms (IND / IMPD submissions, marketing applications, CMC briefing etc.).
• Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing platforms and establishing control strategies for DP processes.
• Be accountable for platform robustness across the portfolio.
• The job holder may act as an expert in specific unit operations. As such, they will be expected to master a body of knowledge for that unit operation and use this to act as the functional expert in the department.
• This expertise will be focused on platform and process primarily within the sterile injectables portfolio.
• Be technically persuasive both within GSK, for example, at project governance, with peers in other departments, or externally, with the academic community.
• Ensure appropriate scientific review is in place throughout development and prior to key Project milestones.
• Prepare and deliver Process Engineering and Analytics-relevant sections of technical and governance presentations and respond to resulting questions. Identify and escalate Process Engineering and Analytics-related risks at scientific reviews and through governance processes. Establishing control strategy for biopharm drug product manufacturing.
• Ability to lead collaboratively in a matrix style environment
• Enable sound decisions by your influence in matrix teams and technical governance, through depth of technical knowledge and effective communication, to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites.
• Deliver the above in a precise and timely manner, adhering to safety and quality expectations. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science and/or engineering with 10+ years of experience
• Experience with aseptic processing, sterile filtration, filling/stoppering operations, and lyophilization processes.
• Experience evaluating, developing, and qualifying DP manufacturing equipment
• Experience of data integrity principles, mentoring/developing staff in proper scientific study design, execution, and report writing

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

• PhD or Master of Science with significant experience in technical leadership, leading matrix team and team with direct reports
• Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals
• Lean Six Sigma (Green Belt or Black Belt)
• Project Management Certification (PMP or CAPM)
• ISPE Training Certificates
• Professional Engineer (PE) License

#LI-GSK
Working Arrangement
This role is hybrid. You will be expected to be on-site regularly to lead experimental and transfer activities, with flexibility for remote work as needed.
What we offer you
You will join a team focused on meaningful impact. You will grow your technical and leadership skills. You will help create processes that enable safe, effective medicines to reach patients. If you are energised by solving practical engineering problems and working across teams, we encourage you to apply.
How to apply
If this role aligns with your experience and goals, please apply. We welcome applicants from all backgrounds and encourage people who value collaboration and learning to join us.
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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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