Associate Director, Process/Facility Engineering

MSD • Rahway, NJ

13d • Onsite

About The Position

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director – Process/Facility Engineering position will report to the Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. CERD is responsible for enabling the pipeline including the demonstration of commercial chemistry and the delivery of clinical material. The process/facility lead role at the Associate Director level will serve as a technical mentor and process team leader supporting the (two) Potent Prep Labs. The Prep Lab is used to generate data which contributes to the knowledge capture of process scale-up and provides API and intermediates for further development and clinical trials. This kilo scale capability establishes operating parameters and ensures successful batches when transferring to pilot scale. RY800-C169 is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing kilo scale laboratory and RY800-B164 is a multi-modality potent development lab, both located at our Rahway, New Jersey campus. The Process/Facility Lead will act as a key leader within the Prep Lab team and will serve as a Subject Matter Expert (SME) in potent, cross-modality, GMP processing and overall capabilities of the labs. The incumbent will lead small teams of operations specialists, project team members, and potentially insourced staff in planning and executing shop floor operations for projects running batches in the Prep Lab. The Associate Director will manage operations specialists and be directly responsible for their onboarding and technical growth, as well as people management responsibilities such as employee development plans (EDP), compensation planning, and performance reviews. The Associate Director will collaborate with their peers in the Prep Lab Team, the Enabling Facilities group and other operations areas such as MACS and the SSO, as well as key stakeholders in Small Molecule Process R&D, Biologics Process R&D, Analytical R&D, Quality, and Safety. This is a hands-on leadership role which includes executing batches. The role will be accountable for driving strategic improvements between periods of GMP and non-GMP manufacturing as well as shop floor tactical execution during both GMP and non-GMP manufacturing with a focus on GMP execution. The role will flow between strategic and tactical assignments, based on the needs of the business. The selected candidate is expected to foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers, chemists, & analysts, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, introduce new technologies, and ultimately to enable flexibility and speed of the Company’s pipeline. This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities.

Requirements

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 7 years relevant experience, or a Master’s degree with 6 years of relevant experience, or a PhD degree with 4 years of relevant experience.
• 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.

Nice To Haves

• Experience in GMP clinical supply facility.
• Experience with Potent Compound processing and containment systems (e.g., isolators).
• Experience interacting with or overseeing the management of process utility systems.
• Experience with coordinating maintenance activities around processing to support reliable facility operation.
• Experience in leading and 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 an executable series of steps and procedures to enable acceptable product manufacture.
• Experience with managing direct reports or matrix teams.
• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Experience building high performance teams, from recruiting to onboarding to ongoing talent development.

Responsibilities

• Primary liaison with lab-based project team members for any steps being run in C169/B164.
• Actively involved in planning and technical transfer of lab processes to the Prep Lab (often the first scale-up opportunity), integrating operational best practices and previous learnings to ensure successful performance in the prep lab.
• Leadership and hands-on execution for GMP processing and non-GMP development work.
• Engineering Step lead for all steps run within C169.
• Oversee campaign planning and equipment utilization.
• Management of electronic batch record process.
• Reviews Process Description and provides coaching to the development team as needed.
• Leads or supports process improvement initiatives (Batch sheet Templates, PAT, knowledge capture, onboarding / training, equipment data sheets, etc.).
• Maintains “just in time” consumables inventory consisting of novel single use equipment for both potent and cross modality operations.
• Provides support to the C169 Lab Lead in compliance initiatives, shop floor staff planning, and mechanical setups as needed.
• Interfaces with Compliance lead for Quality notification investigation related to processing.
• Ownership of Quality investigation closeouts.
• Review of GMP documentation.
• Provide direct support of other areas such as Modality Agnostic Chemistry Scaleup (MACS) and Small Scale Organics Pilot Plant (SSO).
• Manage operations specialists and be directly responsible for their onboarding and technical growth.
• People management responsibilities such as employee development plans (EDP), compensation planning, and performance reviews.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Manager