We are seeking a highly motivated Senior Director of IDMO Site Quality who will play a critical role in the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
This individual will lead the Quality organization (QA/QC) and partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements by leveraging and expanding the site Quality Management Systems (QMS) and ensuring regulatory compliance. This individual will provide strategic leadership to ensure alignment with customer needs and business strategies. As such, 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.
This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Operations, MS&T, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and Finance.
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.
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 requirementsProvide 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 mannerOversee the hiring, development, and performance management of staff within QA and QCDevelop a Quality Culture and compliance related manufacturing and process controls to improve quality systemsEstablish critical KPIs, monitor progress and keep critical stakeholders informed of progressLead and actively participate in all regulatory and internal audits of the facilityWork closely with other functional areas to develop and execute against the strategic plan for the manufacturing siteEstablish key stakeholder relationships with internal and external stakeholders
Requirements
Bachelor's degree in science, engineering, or related field required10+ years of Quality Management experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of senior leadership experienceCell/Gene Therapy and CDMO experience preferredWork effectively with US FDA and other regulatory agenciesSubstantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standardsProven experience implementing continuous improvement initiatives to drive Quality programs and ensure maximum productivityEnsure Quality systems meet the needs of all internal and external stakeholders with an emphasis on process, quality, productivity, budget control, and profitabilityPast 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 guidelinesServe as the point person with industry partners regarding product quality matters, customer satisfaction levels, and regulatory authority interactionMust be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team membersHistory 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 planningStrong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountabilityExcellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organizationExperience with Operational Excellence and/or Lean ManufacturingExcellent organizational and communication skillsSelf-motivated and passionate about advancing the field of cell therapySelf-awareness, integrity, authenticity, and a growth mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
