Head of Technical Operations
Level: Head / VP, Leadership Team Member
Reports to: Chief Executive Officer
Location: New Jersey, Fully on-site
Position Summary:
The Head/VP of Technical Operations will be a key member of the leadership team, reporting directly to the CEO. The Head/VP will be responsible for overseeing the readiness, launch, ramp-up, and management of cGMP operations within our multi-product cell therapy manufacturing facility, in a dynamic CDMO environment. This role includes ensuring that operations are conducted in a safe and respectful environment, adhering to the latest cGMP standards, and meeting production commitments and other asset-related activities in a timely manner. This will be a dual role as the Head/VP of Technical Operations will also be the Site Head. Enabling the support of clinical manufacturing and establishing a roadmap to support pivotal to commercial manufacturing. This role is critical in ensuring operational excellence, scientific rigor, and strategic growth for the client’s cell therapy programs. The role requires partnership with various functions to ensure the safe and compliant production of cell therapy products in accordance with cGMP standards. The ideal candidate will demonstrate proven leadership skills to foster effective communication, coordination, and collaboration across cross-functional teams, ensuring robust production, testing, and timely release of products to patients. The technical operations organization will include the following functions: manufacturing, supply chain / procurement and facilities, engineering and validation, EH&S and IT.
Key Responsibilities:
- Strategic Leadership and Vision: Provide strategic leadership and direction for the Site and technical operations team, including Manufacturing, Facilities/Engineering/Validation, Supply Chain / Procurement, IT, EH&S ensuring alignment with the company’s growth objectives and client-focused manufacturing goals.
- Operational Excellence: Develop and implement best practices for clinical and commercial manufacturing operations, ensuring high standards of quality, compliance, and efficiency. Promote scientific rigor and industry-leading standards in all operational activities.
- Team Development and Leadership: Build and develop a high-performing technical operations team. Provide mentorship and leadership to direct reports, fostering a culture of continuous improvement, accountability, and high performance. Lead and develop an operations team responsible for the site production of autologous and allogeneic cell therapy products, ensuring cGMP compliance. Provide technical and managerial leadership by collaborating with stakeholders to ensure timely manufacturing and product delivery.
- Cross-Functional Collaboration: Establish clear accountabilities and seamless handoffs between process development, Manufacturing Sciences & Technology (MS&T), and technical operations. Collaborate with other senior leaders to drive integrated decision-making and operational efficiency.
- Financial Oversight: Manage the Technical Operations and site cost to achieve financial objectives. Develop and report on key performance indicators to monitor and improve manufacturing performance. Monitor and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People.
- Regulatory and Compliance: Ensure adherence to all regulatory requirements, including GMP standards, health, safety, environmental, and security regulations. Maintain compliance with all relevant government, state, and local laws.
- Infrastructure and Resource Planning: Oversee facilities and space planning, including the design and build of new infrastructure as needed to support the company’s growth and expansion.
Qualifications & Requirements:
- Bachelor’s degree in science, engineering, or related field.
- 12+ years of operations experience in a cGMP biotech/biopharma/CDMO environment, with a minimum of 5 years in leadership; cell/gene therapy experience is essential.
- Proficient in cGMP manufacturing, tech transfer, process validation, project management, and change management.
- Experience interacting with the FDA and other regulatory bodies. Thorough knowledge of Quality Systems, GMP, FDA, GAMP, ISO, and other relevant standards.
- Proven track record of managing and scaling manufacturing operations. Experience in startups or leading organizations through substantial growth.
- 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
- Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
- Ability to manage shifting priorities to meet critical deadlines in a fast-paced environment.
- Track record of developing and mentoring high-performing teams with a strong mission focus.
- Operational Excellence, Lean Manufacturing experience, or Lean Six Sigma certification preferred.
- Excellent organizational and communication skills.
- 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 ability to influence and build strong working relationships at all levels within the organization
- Self-motivated and passionate about advancing the field of cell therapy
- Self-awareness, integrity, authenticity, and a growth mindset
To apply, click the button below or email your resume and the position(s) you’re interested in to recruiter@biocentriq.com.