Associate Director, Process/Facility Engineering

Associate Director – Process/Facility Engineering (P4) Location: Rahway, NJ facility (EF group, Chemical Engineering Research & Development department). Overview Seeking a highly motivated Associate Director to lead the Process/Facility Engineering team within the Enabling Facilities (EF) group. The role reports to the Director of Engineering, supervises operations specialists, and drives both technical and project management initiatives for the Potent Prep Labs and related GMP and non‑GMP manufacturing activities. Responsibilities Serve as technical mentor and process team leader for the two Potent Prep Labs. Lead small project teams, including operations specialists, project members, and insourced staff, in shop‑floor planning and execution of batch processes. Onboard, develop, and manage operations specialists, including employee development plans (EDP), compensation planning, and performance reviews. Collaborate with peers in the Prep Lab Team, EF group, MACS, SSO, and cross‑functional stakeholders (Small Molecule Process R&D, Biologics Process R&D, Analytical R&D, Quality, and Safety). Act as primary liaison for lab‑based project team members, facilitating technical transfer of processes from C169/B164 to the Prep Labs. Lead GMP processing and non‑GMP development work; engineer step lead for all steps run within C169. Oversee campaign planning, equipment utilization, and electronic batch record process management. Review processes, provide coaching, and support process improvement initiatives (batch sheet templates, PAT, knowledge capture, training, equipment data sheets). Maintain just‑in‑time consumables inventory for potent and cross‑modality operations. Provide support to the C169 Lab Lead in compliance, shop‑floor staffing, and mechanical setups. Interface with Compliance lead for quality notification investigations and own quality investigation closeouts. Review GMP documentation and support other areas such as MACS and SSO as business needs arise. Education Minimum Requirement: Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related scientific field with a minimum of 7 years relevant experience; or a Master’s degree with 6 years of experience; or a PhD with 4 years of experience. Required Experience and Skills Experience with small molecule drug substance and/or biologics process development. Experience providing technical mentorship. Ability to prepare Standard Operating Procedures (SOP) and cGMP documents. Effective interpersonal and communication skills, both verbal and written. Excellent organizational skills and ability to multi‑task. Desire and willingness to learn, contribute, and lead. Track record of independent problem‑solving. Desired Experience and Skills Experience in GMP clinical supply facility. Experience with potent compound processing and containment systems (e.g., isolators). Experience interacting with or overseeing process utility systems. Experience coordinating maintenance activities around processing to support reliable facility operation. Experience supporting compliance investigations and change management. Experience with electronic batch record systems. Experience with clean room operations and equipment qualification. Familiarity with US and EU GMP and safety compliance regulations. Ability to convert new drug substance processing needs to executable steps and procedures. Experience managing direct reports or matrix teams. Experience with Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA). Experience building high-performance teams, from recruiting to onboarding to ongoing talent development. Preferred Skills Current employees apply here. Contingent workers apply here. US and Puerto Rico residents only. Salary & Benefits Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive if applicable. Comprehensive benefits: medical, dental, vision, other insurance benefits (employee and family), retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, see EEOC Know Your Rights. Legal Compliance San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. No fee will be paid for an agency referral where no pre‑existing agreement is in place. #J-18808-Ljbffr