Your browser is unsupported!

Update your browser to view this website correctly

Firefox logo Chrome logo Safari logo Opera logo
x

Head of MSAT

OXB-MSAT-1868a
Competitive salary
Permanent
35 / per week - Full-Time
Cowley ,
Oxford

We have an exciting opportunity for a Head of Manufacturing Sciences and Technology (MSAT) within our Technical Operations team.  The purpose of this role is to lead, plan and coordinate MSAT activities supporting the successful development and transition of product candidates for gene and cell therapy, from the laboratory to clinical and commercial supply, for Oxford BioMedica's (OXB) in-house and strategic partner products and programmes.

Responsibilities:

  • Define MSAT’s strategic direction with senior leadership team to maintain OXB’s excellence in gene and gene-modified cell therapies
  • Accountable for leading MSAT: setting clear performance expectations; prioritising work; setting and managing departmental budget; coaching, mentoring and pastoral support; recruitment; training and performance management; setting organisational structure
  • Provide technical and scientific leadership across the business, influencing internal and external stakeholders and influencing key business decisions
  • Engage with OXB in-house development and client-focused programme teams and strategic partners to ensure projects are planned, executed and delivered
  • Oversee MSAT activities focused on manufacturing support & trouble-shooting (across all stages of manufacture including aseptic processing and fill/finish) for investigation of process failures, quality incidents, deviations, corrective/preventative action plans, and change controls
  • Perform root cause investigations and lead multidisciplinary teams in developing and implementing solutions
  • Build technical capability within MSAT in aseptic processing, fill-finish, inspection and packaging to support in-house and third party contract manufacturing operations, providing guidance on best practices to improve aseptic processes and procedures
  • Conduct new manufacturing technology evaluations to drive process improvements and achieve OXB development goals. Foster interactions with academia, suppliers, and / or industry based groups to provide innovative solutions for vector manufacture
  • Accountable for successful new product introduction (technology transfers) into OXB in-house and third-party contract manufacturing sites
  • Accountable for MSAT team authoring, reviewing, and approving technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions, supporting licensing processes at new manufacturing sites
  • Engage cross-functionally to identify and communicate standards and best practices for process design and manufacturing
  • Generate and review documentation supporting technology transfer and NPI to internal manufacturing sites and/or to CMO sites as appropriate
  • Define success criteria for technical transfer and provide expert evaluation of the technical outcomes
  • Input to regulatory submissions for in-house and client projects
  • Lead cross-functional team focus on continuous improvement and operational excellence, improving efficiency and effectiveness
  • Represent MSAT to senior leadership and at strategic partner product and programme technical meetings, business development meetings, due diligence processes and regulatory inspections

Essential requirements:

  • Bachelor’s degree, (Masters/ PhD / EngD preferred) in either life sciences, biotechnology, chemical engineering, or related discipline
  • Strong knowledge and experience of bioprocess development, scale-up and GMP manufacturing (including large scale mammalian cell culture support)
  • Extensive experience in biopharmaceutical/biologics manufacturing and/or process development/scale-up
  • Experience of developing robust and scalable GMP compliant processes for cell therapy, viral vectors, vaccines, or biological products; including knowledge spanning upstream and downstream technologies
  • Significant experience of technology transfer, management of CRO’s/CMOs and/or GMP manufacturing, providing technical expertise to assist troubleshooting issues, during technical transfer or routine production
  • In-depth understanding and experience in all aspects of the process development lifecycle including Quality by Design (QbD), process characterisation studies, and validation of the manufacturing process/facilities/equipment including control strategy development.
  • Knowledge of quality management and regulatory requirements
  • Experience of developing continuous improvement programs for the processes to reduce cost and increase productivity through Operational Excellence and Innovation initiatives

Desirable:

  • Experience of manual and automated fill finish operations
  • Expertise in problem solving tools and methodologies of quality risk assessment
  • Experience using statistical & qualitative data analysis software
  • Experience in process improvement methodologies and quality risk assessments
  • Experience in sterile manufacturing, aseptic processing, and/or fill & finish
  • Mammalian suspension cell culture specific biopharmaceutical/biologics manufacturing and/or process development/scale-up

To apply, complete the application forms online including CV and cover letter showing your suitability for the role.

No agencies please. 


Benefits available immediately:

  • Car Parking
  • On site catering (Windrush Court)
  • E-learning access
  • Professional subscription

Contractual benefits on completion of probation:

  • Generous pension
  • Private Medical Insurance
  • Group Life Assurance

Discretionary benefits on completion of probation:

  • Health Cashback Plan
  • Employee Assistance Plan
  • Childcare Vouchers
  • Discount Portal
  • Cycle To Work Scheme
  • Public Transport Season Ticket Loans

Powered by iintegra | Terms Of Service | Privacy Policy | Cookie Policy