Global Product Steward (Large Molecule & Specialty)

In this position, we can consider candidates in both Upper Merion and Waltham (US), along with Barnard Castle and Ware (UK).

The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Pharma Supply Chain network and site goals and objectives are achieved, and determined strategy executed. MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process. MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support, provide process support across the product lifecycle, while implementing new products and new modalities for commercial products and product-related programs within the GSK PSC perimeter.

As Product Steward, you are the single point of contact for end to end technical accountability for a given product or dose form products. This means providing end to end (E2E) strategic Technical direction and leadership through influence and matrixed reporting relationships, partnering with other MSAT teams, key business units and customers (e.g. Site Operations, Supply Chain, Quality, and Engineering organizations) to implement innovative technical solutions and operational improvements which help achieve targets for safety, quality, supply, and efficiency. As a focal point for the management of technical knowledge, you’ll participate in the development, and later maintenance of, the Control Strategy, Product Knowledge, drug substance and drug product specification discussions, and supporting individual sites to develop and deliver operational control strategies!

We need someone to become the recognized specialist, providing strategic technical leadership, as well as deep technical expertise, to ensure the highest levels of quality and robustness. Partnering with global leaders, you will work to bring GSK products to market. This is a highly visible role with significant networking opportunities. It also offers the chance to hone your technical skills, and to be a true specialist in the field.

There is moderate travel involved, based on product and project requirements. This will be international, including to sites in North America, the UK, and APAC.

Key Responsibilities include, but are not limited to:

• E2E Process and knowledge ownership (bulk/API manufacturing, formulation, filling, packaging, related support activities) for the given product or dose form.
• Accountability to lead all technical projects that span multiple sites or where there are no product owners in place. This includes acting as the key contact within the MSAT Team for API and Drug product related issues.
• Identification, justification, prioritization and facilitation of technical strategic projects to achieve franchise goals. Product Stewards lead or sponsor sophisticated strategic objectives to improve reliability and enable growth.
• Leading PTRT’s or other cross-site, cross-functional technical forums ensuring consistent and technically sound issue resolution.
• Leading the continuous improvement cycle via the development, implementation and maintenance of key goals for associated processes.
• Collaborating in effective product/process transfers as needed, including installation, validation and ongoing continuous improvements.
• Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major changes programmes.
• Providing technical input to regulatory submissions for first file, post-approval submissions and approves NDA / MAA content. As such, you’ll also need to remain conversant with statutory obligations, and GSK procedures for all regulatory requirements, ensuring GSK corporate governance is upheld
• To lead and respond to technical questions during regulatory submission and inspections. Confirms Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved.
• Deploys appropriate standards and training materials / competency frameworks and provides technical coaching, mentorship and training to site-based teams / others across the PSC network.
• Stays current and maintains knowledge of scientific subject matter as well as evolving regulatory policies and guidelines, and industry best practice; encouraging others to embrace them.
• Supporting sustainability efforts in the Large Molecule and Specialty Supply Chain.

About You:

This position requires considerable relationship building and networking, advancing technical ideas and improvements through well-established connections with sites, through site Technical Leads, External Supply Sites and others in Supply Chain leadership and R&D. As such, you will need fantastic communication skills and the ability to translate complicated chemistry concepts and articulate this in a more relevant way for your target audience. You’ll additionally use these skills to influence and lead multi-disciplinary, matrix teams across locations and functions. There is a lot of problem solving in this role, so being solution orientated and highly logical in your approach will help, as well as high levels of independence and organisation. You’ll balance planned activity and reactive crisis management, consistently moving between the two and handling both workstreams successfully, acting as a self-starter and suitably prioritizing as required.

CLOSING DATE for applications: Fiday 9th July (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

Why You?

Required Qualifications:

• MS with 12+ years’ experience / BS with 15+ years’ experience in a scientific or relevant engineering subject area (Biochemistry, Chemical engineering etc).
• Experience in the Pharmaceutical industry, leading the Technical aspects of Product Lifecycle Management.
• Experience of drug products or dose forms, drug product control strategies and unit operations.
• Experience of working with Pharmaceutical manufacturing regulatory bodies (FDA, EMEA, MHRA etc.)
• Experience of Quality by Design and risk management
• Experience in product improvement, troubleshooting, trials and validation and technology transfer

Preferred Qualifications:

• Ph.D Qualification in a scientific or relevant engineering specialism
• Experience of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10)
• Experience of the Pharmaceutical product development process
• Experience in project management
• Experience leading global projects

Why GSK?

GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose – along with our goal of being one of the world’s most innovative, best performing and trusted healthcare companies – helps us attract some of the best and brightest minds in the world.

We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.

We want our company to be a place where diversity of people and thought is valued everywhere and where we’re all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.

• LI-GSK

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