Director, Operations, BBG Advanced Therapies, Manufacturing

BBG Advanced Therapies is a full-service biomanufacturing organization that delivers comprehensive, cell and cell-based manufacturing solutions for advanced therapies. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness. General Summary The Director of Operations will be responsible for maintaining a quality and compliance‑driven manufacturing operation to supply product and other key materials for clinical development of cell and cell‑derived biologics for GenCure and it’s customers. Lead the cGMP manufacturing function, including oversight of the cleanroom facilities, establishment of processes and documentation for the manufacture of cell and cell‑based biologic therapeutics, close coordination with Process Development, MSAT colleagues, and customers to pull projects through clinical production in a phase‑appropriate GMP system. Work closely with the HR team and community organizations to develop a workforce pipeline. This person will also oversee, hiring of individuals to expand GenCure's cGMP manufacturing staff, and contribution to a strategic plan leading to well‑documented, effective and efficient manufacturing of products for GenCure’s customers. Evaluate new customer biomanufacturing opportunities for cGMP production readiness. Provide input for cost of goods analysis (COGs), alternate supply chain assessment, and support the development of statements of work (SOW) with respect to FMEA analysis and cGMP production. Collaborate closely with GenCure Sales and Marketing and New Product Development groups to close accounts and onboard new customers. Represent GenCure at scientific conferences in both a marketing and manufacturing role. Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise. Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes. It is essential that the incumbent have a valid driver's license and be at least 18 years old with a good driving record to meet organization driving standards. Non‑Essential Tasks With assistance from QA, supports development, and implementation of SOPs and other cGMP systems to support onsite cGMP manufacturing capability. Oversees implementation of BBG‑AT manufacturing operations with phase appropriate cGMPs while driving a quality and compliance culture. Maintains projections of BBG‑AT manufacturing schedules and capacity needs across multiple projects. Contributes to and supports implementation of a flexible long‑term manufacturing plan to deliver commercial grade product in accordance with projected production timelines and market demand. Supports development of target objectives for product manufacturing, including cost, scale of manufacture, and key quality metrics. Informs development and implementation of a five year plan to achieve target objectives based on innovation and continuous process and cost improvements. Provide technical guidance and hands‑on expertise for cGMP manufacturing as appropriate. Implements and manages regular customer KPI review meetings to track performance and improve performance. Works closely with Supply Chain management to ensure availability of materials required for GMP manufacturing and clinical operations. As needed, represents the cGMP manufacturing function before customers, regulatory authorities, and senior management as applicable. Seamlessly interfaces with BBG‑AT process development team to assess, engineer, improve and tech transfer new manufacturing processes into cGMP production. Education Requires a Bachelor’s Degree from an accredited four‑year college or university. The required major is Science or Engineering. Prefer a Master’s Degree from an accredited college or university. The preferred major is Life Sciences. Licenses and/or Certifications Valid United States Driver’s License Experience Requires eight or more years of experience in cGMP manufacturing of biologics for clinical and commercial use. Requires three or more years experience in managing a biotech manufacturing team. Strongly prefer cellular therapy experience. Knowledge Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, PMDA, etc. Must maintain knowledge of applicable industry standards, including but not limited to CLIA, AABB and AATB. Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations. Must have excellent knowledge of the organization’s industry in various lines of business, and its key/critical stakeholders. Must acquire and maintain knowledge of the biotech/pharmaceutical industry including multiple therapeutic areas, with special emphasis on regenerative medicine. Skills Must have excellent management skills, including recruiting and building a strong team while driving accountability. Must understand and use performance excellence principles and tools for decision making and planning. Must have excellent process management skills. Must demonstrate positive leadership skills. Must be capable of operating motor vehicles in all types of weather conditions. Must have excellent written and oral communication skills. Must have excellent analytical/critical thinking skills. Must be able to collaborate with peers to achieve positive results for customers in tech transfer and GMP production. Abilities Must be able to keep information confidential. Must be able to support introduction of infrastructure projects into GenCure’s core functions to enable reporting on key operating metrics. Must be able to work with subordinates, peers, and leadership to incorporate new capabilities into cGMP production processes. Must be neat in appearance and well groomed. Must be professional, detail oriented, self‑motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently. Must be results oriented, self‑starter, self‑motivated, a focus on goals, a sense of urgency and creative/ innovative/ forward thinking skills. Must be results‑oriented and a self‑starter with strong interpersonal skills and a focus on goals. Must have strong analytical, numerical, and reasoning abilities in addition to the ability to exercise good judgment. Must have the ability to negotiate, establish, and maintain effective business relationships with partners in our industry and complete transactions. Working Environment Works in a well‑lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend. Ability to use personal motor vehicle for company business required. Occupational Exposure Assignment – Category I Physical Requirements Must be able to drive on behalf of the organization. Will sit, stand, walk, and bend during working hours. Requires manual and finger dexterity and eye‑hand coordination. Required to lift and carry relatively light materials. Requires normal or corrected vision and hearing corrected to a normal range. We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include: Competitive salary 100% Employer Paid Life Insurance 401(k) with Employer Contribution 100% Employer Paid Long‑term Disability Plan Paid Time Off (PTO) 100% Employer Paid AD&D Extended Illness Benefits (EIB) 100% Employer Paid Employee Assistance Program Incentive Compensation Plan Group Health Medical Plan with prescription coverage Shift Differentials Variety of Voluntary Supplemental Insurances Paid Holidays Voluntary Dental Coverage Educational Assistance Program Voluntary Vision BBG Advanced Therapies, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status or other legally protected status. For more information about your EEO rights as an applicant under the law, please click here. BBG Advanced Therapies maintains a Tobacco & Drug‑Free Workplace. #J-18808-Ljbffr