Cellares · 1 day ago
Senior Director, IDMO Site Quality
Bridgewater, NJ
Full-time
Onsite
Director/Executive
$90K/yr - $210K/yr
10+ years expCellares is an Integrated Development and Manufacturing Organization focused on advancing cell therapy manufacturing. They are seeking a Senior Director of IDMO Site Quality to lead the Quality organization and ensure compliance with cGMP requirements while collaborating with various functions to produce cell therapy products.
BiotechnologyLife ScienceManufacturingMedicalTherapeutics
Responsibilities
Lead, direct, coach, and develop an effective QA and QC 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 QA and QC
Develop a Quality Culture and compliance related manufacturing and process controls to improve quality systems
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
Qualification
Required
Bachelor's degree in science, engineering, or related field required
10+ years of Quality Management experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of senior leadership experience
Work effectively with US FDA and other regulatory agencies
Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
Proven experience implementing continuous improvement initiatives to drive Quality programs and ensure maximum productivity
Ensure Quality systems meet the needs of all internal and external stakeholders with an emphasis on process, quality, productivity, budget control, and profitability
Past experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interaction
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 ability to influence and build strong working relationships at all levels within the organization
Excellent organizational and communication skills
Self-motivated and passionate about advancing the field of cell therapy
Self-awareness, integrity, authenticity, and a growth mindset
Preferred
Cell/Gene Therapy and CDMO experience preferred
Experience with Operational Excellence and/or Lean Manufacturing
Benefits
Highly subsidized Medical, Dental, and Vision Plans
401(k) Matching
Onsite lunches
Stock options
Company
Cellares
Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.
51-200 employees
H1B Sponsorship
Cellares has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$355MKey Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M
Leadership Team
Fabian Gerlinghaus
Co-Founder & CEO
Omar Kurdi
Co-Founder and President
Recent News
Genetic Engineering News
2026-01-16
Morningstar.com
2026-01-12
Company data provided by crunchbase