Head of Manufacturing

The Head of Manufacturing will work within CMC to develop and implement operational capabilities and competences for the manufacturing of our Cell Therapy products during all phases of clinical development. The Head of Manufacturing will be an integral part of a small team, where each member is expected to be an ambassador for the company in front of visitors, board members, partners and others.

The culture at Carisma Therapeutics reflects the cutting-edge nature of the company’s work in developing novel immunotherapy treatments for human diseases. Employees come to work every day knowing their actions will have profound value. The team is a close-knit group and has cultivated an atmosphere that is fun and collegial but also goal-focused and fast-paced. There is great passion for advancing exciting and novel science while also building a successful company.

Reporting to Chief Technology and Development Officer, the Head of Manufacturing will work closely with Process Development, Quality Assurance and Regulatory Affairs to define and implement the manufacturing and supply chain strategy for the Carisma cell therapy pipeline. The individual will be responsible for technical oversight of manufacturing & testing units (Contract Development and Manufacturing Organizations, CDMOs) and leading process technology transfers. The Head of Manufacturing will be responsible for the definition and execution of process qualification activities needed in the preparation of regulatory applications. The Head of Manufacturing will also provide conceptual guidance and expertise to Carisma’s Development Team (both internal and external) and contribute to continuous process optimization and characterization throughout the entire product development lifecycle.

The ideal candidate will have: Broad experience in organizing and managing the product development and manufacturing work across CDMOs to move a product through its development life cycle; Strong interpersonal and organizational skills; Extensive experience spanning process development and manufacture of biologics and cell therapies. They will have a proven track record of successful technology transfers, and GMP manufacturing of clinical trial material, in addition to close interaction with Quality Assurance, Quality Control, and Regulatory Affairs. Knowledge and capabilities of project management in order to carry out budget and timeline management.

Responsibilities include:

• Manage and supervise Process Technology Transfer activities and provide technical oversight of GMP manufacturing and testing unit(s) during manufacturing campaigns
• Manage GMP CDMO(s) for the manufacture and testing of vector and/or cell therapy drug products
• Work cross-functionally / collaboratively with Manufacturing, Quality Assurance/Control and Regulatory Affairs to ensure timely manufacturing and release of GMP compliant vector and drug product
• Write and review manufacturing batch records, non-conformance investigations, change controls, SOPs, protocols, technical reports, regulatory documents and memos to summarize experiments and investigations
• Preparation of CMC sections for regulatory submissions (e.g. IND, BLA) in collaboration with other areas
• Extensively collaborate with internal and external partners to evaluate and implement new process technologies to develop next generation processes
• Interact with internal cross-functional team members including Manufacturing, Nonclinical, Clinical, QA, Regulatory, Legal, and Discovery
• Work effectively in a team environment as well as contributing individually
• Manage teams to meet project timeline and objectives
• Manage project budgets and timelines in support of product development campaigns
• Develop and manage the Supply Chain strategy, including product logistics for each product
• Perform other duties as assigned

Requirements:

• Advanced Degree in Engineering or Biochemical Sciences with at least 10 years of relevant experience in biopharma process development or manufacturing experience of complex biologics; strong preference given to candidates with cell and gene therapy manufacturing experience
• Excellent working knowledge of GMP requirements
• Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of biological products
• The ability to organize and report data and present findings to senior management is required
• Knowledge on how to prepare CMC sections for regulatory submissions (e.g. IND, BLA) in collaboration with other areas
• Subcontract management experience, including the ability to generate RFPs, negotiate contracts and manage complex contracts and vendors
• Ability and experience to successfully organize and manage teams of non-local, both internal and external, resources to a common goal with minimal supervision
• Experience with team-based collaborations or direct management of staff is required
• Highly organized with thorough attention to detail, ensuring timely follow-through and closure
• Ability and willingness to travel
• Excellent analytical, critical thinking, and soft skills to build collaborative relationships enabling effective and harmonious interactions with vendors and stakeholders
• Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, interpersonal skills and a helpful team spirit
• Flexibility and adaptability, “can do” attitude

Benefits include: competitive pay, health, dental, short and long-term disability insurance, flexible spending, monthly subsidy for transit/commuting or flex spending, 401K, paid holidays, and paid time off.