Operations Lead (Shop Floor Supervisor)

Job description

Job Description The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides pilot plant operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the MACS Operations Team at the Rahway, NJ facility. Responsibilities of the Specialist –Process Supervisor include the following: The process supervisor role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently under construction in Rahway, New Jersey. The Specialist will serve as a team member from testing and startup through to when the MACS facility is fully operational. They will also potentially support other new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. (see “Additional Supported Areas”) As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. The selected candidate is expected to be a key part of an operations team and foster a culture of collaboration, learning and innovation. The incumbent will supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements to meet MACS objectives and customer requirements. This role will also be responsible for the prioritization and assignment of daily activities for the operations staff. The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements. This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the facility’s performance. Ultimately, this position is expected to work cooperatively with the MACS leadership team and cross-functional MACS partners to drive overall success and performance of the building. Additional Supported Areas: As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area: The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space. Education Minimum Requirement: Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment. — OR— High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility. Required Experience and Skills: Mechanical aptitude and familiarity with chemical process development and process equipment. Supervising a team of shop floor personnel in an operations environment Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations. Experience operating/maintaining manufacturing scale, pilot scale, and/or lab scale equipment. Effective communication skills and a collaborative mindset. Experience in conflict resolution and root cause analyses. Ability to build effective work relationships with a varied workforce. Adaptable to a dynamic production environment. Relevant experience in a process development lab or pilot plant/manufacturing facility. As the building transitions towards equipment qualifications and operations must be able to rotate between 1st and 2nd shift on a weekly basis. Desire and willingness to learn, contribute and lead. Coordinating maintenance activities around processing activities to support reliable facility operation. Working in an environment with Automation Systems (DeltaV, PLC, etc.). Desired Experience and Skills: GMP facility design, equipment start-up and/or qualification. Small molecule drug substance and/or biologics process development. Supporting compliance investigations and change management. Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) Potent Compound processing and containment systems (e.g., isolators). Interacting with process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. Quality systems notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC). Required Skills: cGMP Guidelines, Competency Management, Corrective Action Management, Electronic Batch Records, Manpower Planning, Manufacturing Processes, Pilot Plant Operations, Process Engineering, Root Cause Identification, Root Cause Investigations, Troubleshooting Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of 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, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would p