Vice President of Operations
1 month ago
We are seeking a highly motivated and experienced Vice President of Operations to lead our cell therapy manufacturing operations. The successful candidate will be responsible for overseeing the launch, ramp-up, and oversight of cGMP operations within our state-of-the-art multi-product cell therapy manufacturing facility.
This individual will partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. The role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross-functional groups to ensure robust production, testing, and release of product to patients.
The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Key Responsibilities- Lead, direct, coach, and develop 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
- In charge of the multiple work centers within the facility to ensure high quality and compliant product supply with oversight of production metrics, including Safety, Quality, Compliance, Cost, Delivery, and People
- 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
- Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
- Establish key stakeholder relationships with internal and external stakeholders
- 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
- Cell/Gene Therapy and CDMO experience preferred
- Work effectively with US FDA and other regulatory agencies. 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
$200,000 - $300,000 a year
Cellares' total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
All displayed pay ranges are approximate, negotiable, and location-dependent.
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