MS&T Drug Substance, Senior Manager

MS&T Drug Substance, Senior Manager

This fixed term contract based role will report into the Director, MS&T, can be remote based in UK

The preferred candidate will be a subject matter expert in upstream processing involved with Technology Transfers (preferably with CDMOs), with min 6 yrs experience. They should have proven experience in delivering these projects from Kick-off to submission (end to end, or equivalent).

• This role bridges technical expertise and operational leadership within MS&T, specialising in Large Molecule, Drug Substance (DS) operations.
• The role works in close collaboration within the external manufacturing operations team and the New products and Franchise Lead within MS&T .
• The role will provide strong scientific and technical leadership and oversight for Technical Transfer projects between Contract Manufacturing Organisations.
• The role requires strong technical oversight of manufacturing processes, including management of change controls, review and approval of batch documentation, implementation of new technologies, root cause analysis, and process troubleshooting for complex manufacturing deviations
• This position is responsible for Technology Transfer, process scale-up, process validation activities, realising manufacturing readiness for commercial supply, supporting risk assessment, process troubleshooting, drug product manufacturing activities for Large Molecule Drug Substance.
• Other responsibilities will include cross-functional team leadership and / or membership, authoring technical reports and supporting aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including Pharmaceutical Development, RA CMC, and Quality, working towards existing and new product integrations, and ensuring all processes are understood, robust, efficient and in control.
• The role will also require delivery of projects through external partners, with ownership of internal activities for oversite and related supporting assessments & reports. Working in partnership with CMOs and ensuring projects are delivered on time, to the required standards.

Essential Functions/Responsibilities

• Act as a technical lead for DS operations, supporting technical transfers and troubleshooting.
• Lead technology transfer and scale-up projects for DS, ensuring alignment with QbD principles and regulatory expectations.
• Technical ownership / leadership of Mammalian Cell Culture processes, with application of Perfusion technology, and associated downstream / purification technologies, including the commercial scale development, qualification and validation of these processes.
• Specific experience in delivering Technology Transfer Projects for the above processes
• Provide strong technical proficiency, scientific creativity, and collaboration with others.
• Deeper knowledge and application of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles.
• Experience of leading the technical agenda & relationship between the team and with the relevant CMOs technical team at the site of manufacture.
• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.
• Highly flexible, works well in a team environment, and has the necessary skills to organize, mobilize, communicate, & influence.
• Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and procedures.
• In conjunction with Quality Operations ensure that CMOs are qualified and approved.

Person Spec

• Deep expertise in DS manufacturing process and technologies:
• Upstream Processing, Inoculum expansion, seed train management, and bioreactor operations with perfusion fed batch technology including Process control of critical parameters
• Harvest and Clarification, Centrifugation, depth filtration, and clarification technologies.
• Downstream Processing including Chromatography operations including Protein A, ion exchange, hydrophobic interaction, affinity, mixed-mode purification, and ultrafiltration/diafiltration (UF/DF) processes
• Proficiency in GMP operations, process validation.
• Strong understanding of CMC regulatory requirements and QbD principles.
• Excellent organizational, verbal, communication, presentation, and data analysis skills.
• Ability to effectively participate in multi-disciplinary teams and proficient in working with CDMO vendors.
• Strong understanding of project management processes, risk management processes, pharmaceutical quality management systems and pharmaceutical regulations
• Strong personal ownership for skill / technical development.

Required/Preferred Education and Licenses

• Advanced degree, in Chemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or related discipline (MSc, PhD) desirable.
• Minimum 8 years working in the pharmaceutical industry in technical and / or manufacturing role.
• Significant experience in biologics drug substance manufacturing within a GMP environment.
• Demonstrated expertise in process development, manufacturing support, validation, technology transfer, and deviation management.
• Strong knowledge of regulatory requirements, quality systems, statistical analysis, and risk management principles.
• Proven ability to influence cross-functional teams and lead technical initiatives in a complex manufacturing environment.
• Project management skills for technical programs is desirable.

International Travel : 20-30%