Senior Director, Clinical Manufacturing
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built strong pipelines of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. For more information about Eureka Therapeutics, please visit: www.eurekatherapeutics.com.
Eureka Therapeutics Inc. is looking for a Senior Director, Clinical Manufacturing for CMC management to build and lead a team responsible for developing, optimizing, planning, budgeting, integrating, tracking and communicating of CMC activities across the Company’s product pipeline programs of novel autologous T cell therapies. This position will be reporting directly to the Chief Medical Officer (CMO) and will be responsible for implementation of all manufacturing activities within the company and is accountable for the resourcing, development, training and management of a successful GMO operation. Eureka is a high growth, fast paced, small organization. The ability to be productive and successful in an intense work environment is critical.
- Manage process development experiments to translate robust, efficient, and scalable cell culture processes to clinical GMP manufacturing facilities and manage the continued optimization of cell manufacturing and CMC processes to fulfill requirements for later phase trials and commercialization.
- Actively identify, evaluate and qualify potential contract manufacturing sites, be the contact person for all the processes including the ongoing operational activities, quality risk management and contracting negotiations, reporting the progress clinical team and troubleshooting as needed.
- Prepare and manage Standard Operating Procedures, batch records and other process documentation.
- Prepare CMC sections and other documents for regulatory filings.
- Oversee QC/QA and related activities for Phase I trials and future process validation for later Phase trials and commercial manufacturing.
- Establish and drive best project management practices for CMC activities required for projects from inception through to commercialization.
- Ensure the documentation, tracking and communication of CMC timelines, objectives, deliverables and budgets.
- Collaborate with senior management, CMO and partners to ensure linkage between strategy and operational activities.
- Attend and present corporate/scientific information at appropriate and relevant conferences and symposia.
- Minimum B.S., Ph.D. preferred, in Biological Sciences, Bioengineering, Chemistry or a related discipline.
- 10+ years of industry experience with a primary focus on the project/program management of CMC related activities.
- Experience with CMC activities for gene and/or cell therapy products.
- Solid understanding of regulatory requirements for CMC and for gene and/or cell therapy from initial IND through to commercialization.
- Experience managing Contact Manufacturing Organizations and vendors.
- Experience with global drug development and BLA filing is important; experience in developing manufacturing documents, SOPs, INDs, Module 3 writing for, BLA/NDAs is critical.
- Demonstrated ability to effectively manage multiple projects and people. Proactive problem solving abilities and follow-through.
- Strong communication and presentation skills-demonstrates strong written and verbal communication skills.
- Ability to work in a very dynamic environment of scientifically driven biotech, with limited resources and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems.
- Must have a thorough knowledge of cell manufacturing concepts, practices, and FDA regulations and ICH Guidelines and QA/QC methodologies.
- Self-motivated to maintain expertise in quality and GMP requirements and guidance to ensure that manufacturing remains compliant with GMP and other global regulatory guidelines or laws
- For the best fit, the candidate should be a results-oriented, have outstanding organizational skills, a team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.
Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.
Please submit your resume or CV and cover letter via Jobscore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.