Mantell Associates
Mantell Associates is partnered with a leading Cell Therapy CDMO, who are seeking a Manufacturing Lead to join their growing team.
Manufacturing Lead – Responsibilities:
- Design and develop comprehensive training programs for the operations team
- Ability to assist in training company-wide, to include development and quality control
- Conduct engaging and interactive training sessions for diverse audiences
- Utilize various training methodologies, such as workshops, webinars, and hands-on practical sessions, to cater to different learning styles
- Implement and maintain quality assurance processes for training programs, ensuring content accuracy and relevance with good documentation practices
- Stay informed about regulatory requirements and industry standards related to CDMO’s and Cell and Gene Therapy
- Integrate regulatory compliance elements into training programs to ensure participants are well-versed in the necessary guidelines
- Stay updated on the latest advancements in cell and gene therapy to incorporate relevant content into training material
- Serve as subject matter expert on cell and gene therapy, providing insight and guidance to internal and external stakeholders
- Collaborate with other teams to ensure training content reflects the latest scientific and technological advancements
- Gather feedback from participants to continuously improve and enhance training materials and delivery methods
- Ensure training is up-to-date and perform refresher training courses to cover gaps, process changes, or CAPAs
- Maintain training records and inform the team when re-qualifications are due
- Work with supervisors to ensure time is segregated for training
- Keep open communication with management to ensure training activities are completed in a timely manner
- Collaborate with cross-functional teams to ensure a holistic approach to training
- Perform other duties as assigned
Manufacturing Lead – Requirements:
- High School Graduate with related experience or Bachelors
- BS/MS in Science or related discipline
- Training Certification
- 2+ years of experience as a trainer in the Cell and Gene Therapy industry
- Experience supporting the Operations Team in training
- Thorough understanding of cGMP per FDA and EMA regulations
- Hands-on experience of GDP
- Hands-on experience of gown qualification and cell therapy unit operation-based training
- Excellent interpersonal and communication skills
- Ability and flexibility to work independently and collaboratively in a dynamic, fast-paced environment
- Be a Subject Matter Expert in aseptic technique
- Excellent organizational skills
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.