Associate Director, Aseptic Observation Program - Summit West NJ

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.Position Summary: This leader will shape the operational culture from the ground up, ensuring the site is staffed with exceptional talent, achieves operational readiness on an aggressive timeline, and continuously delivers operational excellence in a highly regulated, patient-centric environment.As the Associate Director of the Aseptic Observation Program, you will provide strategic leadership and direction for the team responsible for overseeing aseptic practices within Cell Therapy manufacturing cleanrooms and supporting environments. You will be accountable for ensuring that operators, verifiers, and support personnel consistently demonstrate proper aseptic techniques and behaviors, in line with the principles outlined in the Contamination Control Strategy. This role is instrumental in defining, reinforcing, and maintaining standards that prevent personnel-related risks to the manufacturing environment.In this capacity, you will directly support and guide the Aseptic Observation Program Leads, fostering the development of a high-performing team of observers. Your leadership will drive collaboration with Manufacturing, Quality Assurance, Training, and other cross-functional teams to advance aseptic performance and uphold a culture of excellence in quality and manufacturing. You will be responsible for identifying and addressing behavior drift, providing real-time constructive feedback, and coaching personnel to ensure continuous improvement. Additionally, you will analyze trends in aseptic performance, contribute to root cause analysis, and champion initiatives that strengthen contamination control and operational effectiveness.Key Responsibilities:Provide strategic leadership and oversight to the aseptic observer team, guiding and mentoring team Leads to ensure effective execution of their responsibilities and alignment with organizational objectives.Lead the implementation and continuous enhancement of aseptic observation processes on the manufacturing floor, evaluating operator behaviors, aseptic technique, and compliance with Contamination Control Strategy principles.Establish robust documentation practices for observations, delivering actionable coaching and feedback to both personnel and area management to drive sustained improvements in aseptic performance.Collaborate with Sterility Assurance, Manufacturing, and Quality teams to optimize observation procedures, operational SOPs, and comprehensive training programs that reinforce best practices.Represent the Aseptic Observation Program in cross-functional meetings, presenting key insights and recommending process optimizations based on trend analysis and observational data.Champion enhancements to the Contamination Control Strategy, including the development and dissemination of aseptic processing methodologies, gowning standards, and cleanroom behavioral expectations.Direct the creation and revision of aseptic training materials, incorporating real-world scenarios and lessons learned from observations to increase engagement and effectiveness among manufacturing staff.Oversee the planning and delivery of targeted training sessions, ensuring challenges identified through observation are addressed and best practices are reinforced across the organization.Analyze trends in aseptic performance, lead the identification of systemic issues, and drive continuous improvement initiatives to elevate operational excellence.Review and synthesize aggregated observation data to identify recurring challenges, propose strategic corrective actions, and monitor the impact of implemented solutions over time.Lead root cause analysis, CAPA development, and deviation investigations related to aseptic practices, providing expert guidance and supporting the design of effective preventive measures.Partner with investigation teams to deliver comprehensive observation insights, facilitate fact-finding, and ensure the adoption of robust preventive strategies.Oversee the execution and closure of corrective actions resulting from observations, ensuring timely resolution and long-term sustainability of improvements in aseptic practices.Ensure regulatory inspection readiness by maintaining accurate observation records, rigorous documentation standards, and demonstrable program effectiveness.Stay abreast of industry best practices, evolving regulatory requirements, and emerging trends in aseptic processing, proactively strengthening the observation program and Contamination Control Strategy.Additional Qualifications/ResponsibilitiesQualifications required:Specific Knowledge, Skills, Abilities:Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talentStrong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadershipEffective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plansProven proficiency in coaching and providing feedback for front line operators is required. Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulatory environment. Understanding of aseptic processing principles, cleanroom behavior standards, and contamination control strategies.Strong observational, analytical, and critical-thinking abilities.Adaptable to a fast-paced, complex, and ever-changing business environment. Education/Experience/ Licenses/Certifications:Bachelors in relevant science or engineering discipline, or equivalent in work experience.8 - 12 years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirementsExperience in the following is highly preferred:Cell therapy manufacturing observations, training, or management.Aseptic processing in ISO 5/Grade A biosafety cabinets.BMSCARTIf you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Summit West - NJ - US: $163,210 - $197,770

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