Compass Life Sciences are working with an innovative biotechnology business that are developing cutting edge immunotherapies using T cell receptors to provide new therapies for cancer treatment. Working in an area of rapid growth and investment, and advancements pushing the boundaries of medical science, our client is developing platforms and therapies that are drawing significant interest from the wider industry.
Due to continued positive data reports from pre-clinical and early clinical studies, our client has reached an incredibly exciting period of their development and are now looking to bolster their leadership talents to support the next stage of their journey. They are searching for a talented and experienced leader to plan, develop and implement the CMC process for their late stage clinical development programmes and commercial manufacturing strategies for their portfolio of cellular immunotherapy products.
The Role
Reporting to the Vice President of CMC, you will have responsibility for building a complete supply chain of critical material, manufacturing equipment, management of finished drug products, and logistics associated with their distribution. This position will represent and work within CMC but cross-functionally with various stakeholders including Quality Control, Quality Assurance, Project Management, Clinical Development, and Clinical Operations on all aspects of drug product distribution and logistics. The position will be responsible for working with external partners and vendors for the procurement of necessary manufacturing material and necessary supply agreements. This position will be responsible for sourcing and qualifying manufacturing facility solutions along with the CMC leadership and for adaptation of the manufacturing processes for new facilities and necessary technology transfer.
Key Responsibilities
- Plan, develop, and implement manufacturing strategies and processes for late-stage clinical development and commercial uses for cellular immunotherapy products.
- Oversee activities related to the selection of facility solutions including Contract Manufacturing Organizations (CMOs), as well as the businesses own internal or partner facilities.
- Oversee the supply chain for procurement of raw material necessary for the manufacturing of products.
- Develop, implement, and manage master supply agreements with key vendors including critical raw material and viral vectors to supply compliant biological drug substances for the clinical, launch and commercial phases.
- Oversee safe, compliant and efficient operation of area processes, Good Documentation Practices, timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure inspection readiness.
- Oversee technology transfer activities from CMC to external CMOs or other manufacturing facilities.
- Responsible for ensuring that the manufacturing facilities are compliant and inspection ready by both US and international regulatory agencies.
- Perform market research and analyse threats and opportunities in manufacturing start-up and growth.
- Establishing operational budgets and forecasting for equipment (CAPEX), material as well as capacity allocation in line with supply plans.
Requirements
To be considered for this role, our client is looking for seasoned and talented professionals that are able to demonstrate the following experience;
- Master's or PhD Degree in in Chemical/Biochemical Engineering, Biochemistry or related scientific discipline.
- Experience working in Lean/Operational Excellence environment with certification in lean tools.
- A minimum 8 years of experience in the cell or gene therapy field and 3 years of experience in with biopharmaceutical late-stage clinical development and/or commercial manufacturing, supply chain logistics, and material management duties.
- Proven background in leading product commercialization in the cell & gene therapy industry.
- Working knowledge in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
- Experience in client and vendor relationship management.
- Exceptional expertise and working knowledge of cGMP guidelines and knowledge of Quality System that meets global regulatory expectations.
- Understanding of industry trends and leading methodologies.
- Experience with process scale up principles and involved tech transfer activities for clinical and commercial production scales is preferred.
- Solid knowledge of regulatory compliance and GMP systems at least in the US in EU.
- Excellent communication and interpersonal skills.
In addition to this our client is looking for those who are able to work independently, and that have excellent analytical reasoning and communication skills. You will need to be excited about working in a rapidly changing and growing business where you will be able to be open minded, think outside of the box, and demonstrate flexibility in an environment which is constantly striving for excellence. You will also be highly structured in your approach, combined with accountability, enthusiasm, and strong social skills.
In return you can expect to work with a highly committed and inspired team in a collegial, highly motivate and family-friendly atmosphere. Their culture is one where originality, independent thinking and initiative are welcomed. As well as a competitive basic salary you can also expect an excellent package including subsidized health, dental, vision, as well as insurance, 401(k), paid holidays, paid parking and various other insurance's, perks and benefits.
If you are interested in a confidential introductory conversation about the role and your own situation, please contact David Jolley at djolley@compassltd.co.uk, or call +44 (0)7738 58 66 27, or +44 (0)2393 87 73 58.
Compass Life Sciences are a trading name of Compass Associates Ltd, and are acting as a Recruitment Consultancy for this permanent vacancy.
