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Senior Director of Operations
2 months ago
We are seeking a highly experienced Vice President of Operations to lead the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility. The successful candidate will partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements.
Key Responsibilities- Lead and direct an effective Operations team responsible for daily clinical and commercial production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements.
- Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner.
- Oversee the hiring, development, and performance management of staff within operations.
- Lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- Establish critical KPIs, monitor progress, and keep critical stakeholders informed of progress.
- Lead and actively participate in all regulatory and internal audits of the facility.
- Bachelor's degree in science, engineering, or related field required.
- A minimum of 12+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experience.
- Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO, and other applicable standards.
- Demonstrated experience in managing commercial manufacturing operations.
- Demonstrated startup experience or leading organizations through dramatic growth.
- Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
- Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment, while providing clear direction to team members.
- History of developing and building cohesive, high-performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning.
- Strong analytical, problem-solving, and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization.
- cGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management.
- Experience with Operational Excellence and/or Lean Manufacturing.
- Excellent organizational and communication skills.
- Self-motivated and passionate about advancing the field of cell therapy.
- Self-awareness, integrity, authenticity, and a growth mindset.
We offer a competitive total compensation package, including a base salary of $200,000 - $300,000 per year, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
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