Drug Substance Director - Large Molecule

Join GSK at our Upper Marion, PA or Rockville, MD site as the Drug Substance Director, Large Molecule where you will provide strategic technical direction and leadership to your team, ensuring the Drug Substance Leads are transferring their processes and products in accelerated, innovative and right first-time ways. This is a senior position within the MSAT organization. You will be the single point of technical accountability for biologics drug substance. You will lead a team of Drug Substance Leads responsible for leading transfers of new products from R&D to GSC, and existing products within GSC, leading technology transfer across supply nodes, monitoring process performance and providing process support across product lifecycle.

This role will be responsible to maintain a network to ensure the necessary support and input are provided to other MSAT teams, key business units and customers (e.g. Site MSAT, Operations, Supply Chain, Quality, Engineering and R&D organisations). This leadership spans NPI and growth sites and external supply commercial products. Another key feature of the role will be to support and grow capability of the team in order to successfully discharge the necessary technical support and input across NPI and external supply commercial products, balancing the needs of the business priorities

In this role, you will have a recognised competency in the given dose form and will own the technical strategy for the platform. In addition to strategic technical leadership, the role will be expected to provide deep technical expertise where required to support the team and ensure highest levels of quality and robustness.

Department Mission:

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 Global Supply Chain network, site goals and objectives are achieved, through a focussed strategy execution.

MSAT is the keeper of the body of knowledge associated with the formulation, device components, analytical testing and manufacturing unit operations, creating the instruction set and ensuring manufacturing operations stay aligned with the registered process. The primary objective is to ensure manufacturing processes are capable, compliant, in control, continuously improved and aligned across Sites.

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 improvement programs within the GSK GSC perimeter.

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

• Building and maintaining a capable team, able to operate across both new product introduction and commercial assets manufactured internally and externally, to service the needs of the wider GSC business.
• Single point of technical accountability on behalf of MSAT for Drug Substance platform (biologics), delivering a continuous improvement programme for the platform.
• Support to the team through influencing senior management of internal sites and existing and potential contractors in the development of a technical strategy that supports GSK business needs.
• Provide technical expertise and input to due diligence activities.
• Manage Team to deliver technical and knowledge transfer, including scale-up and pivotal batches, between R&D / GSC / CMOs to ensure successful product development and launch.
• Maintain liaison with all appropriate GSK Technical groups, ensuring that technical specialists from elsewhere in GSK are connected and effectively managed to support major projects and technical initiatives within the biologics team, whether NPI or commercial products.
• Supporting & managing the planning and implementation of all the technical aspects of product transitions and technical transfers to and from the CMO Network (inclusive of new CMOs, new products, product line extensions, contractor rationalisations and product transfers).This involves application of relevant process, pharmaceutical technology expertise, and effective knowledge transfer.
• Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major changes programmes.
• Deploys appropriate standards and training materials / competency frameworks and provides technical coaching, mentorship and training to teams & others across MSAT as required.

Basic Qualifications:

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

• Ph.D. with 10+ years' experience, OR Masters with 12+ years' experience OR Bachelors degree with 15+ years' experience in a scientific discipline with demonstrated experience in the pharmaceutical industry in leading the technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, validation and change control.
• Previous experience leading a technical team.
• Demonstrated experience and technical knowledge of product or dose form, individual to be recognised as a competent individual, with knowledge of drug product control strategies and unit operations.
• Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management.
• Experienced in technology transfer, with an understanding of the product development process.
• Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements.

Preferred Qualifications:

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

• Excellent problem solver and ability to think and work creatively.
• Team builder - able to grow and develop others
• Demonstrated knowledge of Quality by Design and risk management approaches
• Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
• Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
• Project management and prioritization skills gained within a complex matrix.
• Demonstrated ability in effectively leading, influencing and working in multi-disciplinary teams across sites and functions including R&D, Technical, Quality, Regulatory and Engineering.
• Demonstrated self-starter with strong self-management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization.
• Ability to support due diligence activities.

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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 immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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