The Director/Senior Director, External CDMO Manufacturing, reporting to the VP of Technical Operations and Manufacturing,will be responsible for managing activities related to the GMP production of early and late phase clinical materials produced at contract development and manufacturing organizations (CDMOs) for Catamaran’s in-house allogeneic CAR-NK cell therapy programs. This role will be responsible for working with internal and CDMO staff for the oversight and coordination of activities related to scheduling, manufacturing, quality, finances, supply chain and regulatory. They will act as primary relationship manager and point of contact with the CDMO(s) for cell therapy manufacturing while working closely withinternal Catamaran staff.
- Developing timelines, budgets and coordinating execution of activities for all elements related to the GMP production, testing and fill finish of products manufactured at CDMO(s)
- Collaborating with Process Development and Analytical Development groups to ensure successful transfer of Catamaran’s manufacturing processes and analytical assays to the CDMO(s)
- Collaborating with external vendors and Catamaran’s Finance department to ensure critical raw materials and reagents are made available at the CDMOs to ensure timely execution of clinical product campaigns
- Leading and facilitating meetings between Catamaran and the CDMO(s) project team members.
- Coordinating the generation, review, execution and completion of scope of work documents, corresponding purchase orders, invoicing and any necessary change orders
- Tracking project activities, deliverables, and completion relative to budgets and Catamaran’s objectives
- Independently managing reviews of batch records and in-process results
- Assisting in generating technical reports and tech transfer documents
- Writing/revising SOPs and batch records as needed.
- Collaborating with Clinical Operations to ensure that cell products are available for clinical trials.
Education, Qualifications & Experience
- Degree in Biology or Life Sciences, bachelor’s degree/8 years’ experience or Master’s degree/5 years of relevant industry experience
- Strong understanding of cGMPs including change control, CAPAs, lot release and validation
- Highly organized and detailed oriented
- At least 5 years of project management or site management experience for cell/gene therapy programs
- Extensive experience in all aspects of project management including working with tools such as Microsoft Project and Smartsheet, creating trackers, dashboards, and other reporting tools
- Excellent communication skills
Catamaran Bio is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.