Head of Manufacturing, Stem Cells
Longboat is seeking a Head of Manufacturing who will be responsible for organizing, managing, and continuously improving the manufacturing operations and processes.
Are you ready to join a team committed to moving cell therapies into clinical and commercial settings by supplying high quality neonatal amniotic GMP MSCs for cell therapy use? Longboat is at the start of an exciting journey, and we are looking for passionate individuals to join us on this important mission.
Longboat is a stem cell company, dedicated to developing and commercializing novel treatments for the benefit of patients suffering from rare and life-threatening airway diseases, and to supply high quality amniotic Mesenchymal Stem Cells (MSCs) to universities, hospitals, the biotech industry, and clinical-stage pharmaceutical companies for other indications.
Longboat is seeking a Head of Manufacturing who will be responsible for organizing, managing, and continuously improving the manufacturing operations and processes at the Longboat manufacturing site. In this position, he/she will be responsible for the management of commercial and clinical drug product supply as well as the development of processes and tech transfer. Longboat is currently a small start-up and the candidate is expected to have direct hands-on experience with cell culture and manufacturing so as to be able to lead, motivate and instruct a small team of Production Scientists (Bio-Process Engineers), whose direct responsibilities include performing all tasks related to the production process. The Head of Manufacturing will be responsible for handling process and equipment deviations on the floor. Areas of responsibility will include both upstream (cell culture), downstream (Purification), and fill/finish activities.
The candidate for this position must be able to provide technical expertise in the areas of aseptic processing and fill/finish, drug production technology transfer, visual inspection and process analytics. The candidate will identify risks and drive continuous process improvements through technological and operational innovation for drug product manufacturing processes. He/she must lead the design, development and technology transfer for new and existing manufacturing processes and develop processes to monitor and manage the day to day interaction of drug product manufacturing operation to ensure clinical and commercial supply. The position will report to the CEO. All in all, Longboat envisions to be a team of ca. 15 people in a year’s time.
- Produce clinical and commercial material on an annual basis that meets the site’s strategic objects and is compliant with GMP and safety regulations.
- Schedule daily operations (finite scheduling) for manufacturing and cleaning processes. Ensure manpower resources are adequate to complete operations.
- Lead investigations as related to the manufacturing process. Author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
- Ensure documentation (batch records and SOPs) are accurate and updated as required.
- Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
- Provide monthly manufacturing metrics as determined by management.
- Lead areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects.
- Identify and implement continuous improvement opportunities.
- Lead and mentor staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.
Qualifications. The following is highly desirable:
- Broad scientific expertise relating to cell therapy manufacture, with experience of working within the industry.
- Experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, aseptic fill/finish with in-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements.
- Experience with cell therapy manufacturing.
- Experience working with cell therapies or a related field including experience of working outside of academia.
- MS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. PhD in Cell Biology (or a related subject) plus several years of experience in a field relating to cell therapies preferred.
- PhD Experience in the use of a range of technologies that can be applied for small scale automation of cell therapy processes.
- Experience of human cell culture using a range of cell models.
- Experience of CoGs models and their use in defining a process optimization strategy.
- Thorough understanding of analytical techniques for product characterization including flow cytometry, RT-qPCR, ELISA.
- Knowledge of in-vitro assays for cytotoxicity and functionality.
- Knowledge of product release tests.
- Experience of working with a QMS including the drafting and management of SOP’s
- Ability to manage multiple and varied tasks and to prioritize a workload whilst maintaining attention to detail
- Proven ability to consistently deliver to time, cost and quality standards
- Knowledge of GMP regulations in relation to the manufacture of cell therapies or biologics.
- Experience of writing and carrying out GMP production protocols.
- Substantial peer-reviewed publications and/or patents that demonstrate research productivity and the ability to perform cutting-edge research.
- Excellent oral and written communication skills including report writing.
- Ability to work quickly and accurately, with limited supervision, taking initiative when required.
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
- Proven leadership and the ability to inspire a team.
- Confidence to manage upwards to Executive Management level.
Please note this job description is not an exhaustive listing of activities, duties or responsibilities for this job. Duties, responsibilities and activities may change over time.