Job Description
MACS (Modality Agnostic Chemistry Scaleup) Operations group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the MACS Operations team at the Rahway, NJ facility. Responsibilities of the Operations Specialist include the following:
The Operations Specialist role at the Associate 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 under construction in Rahway, New Jersey. They will serve as a team member for the MACS Center startup and testing phase and will go on to support MACS pilot plant operations and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.
As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, equipment or material testing, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. Additionally, the selected candidate will be a key contributor to the Operational Readiness program with the purpose of establishing the procedures, documentation, and training necessary to operate and maintain a new business area after completion of the facility startup. The selected candidate is expected to be a key part of the operations team and foster a culture of collaboration, learning and innovation.
They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies. Once the MACS Center is operational, additional tasks could include equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, solvents, and active pharmaceutical ingredients during “wet chemistry” operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as well as dry powder processing (e.g., dry milling).
Additional Supported Areas:
As required and in addition to support of current capital projects the Associate 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. The Prep Lab includes a cleanroom suite for GMP small-scale manufacturing of potent and multi-modality clinical materials. 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, Chemistry, Biology, Pharmaceutical Sciences or related scientific field plus one (1) year relevant work experience – OR - Associate in Science, Associate in Applied Science (ideally in Process Technology), or Associate degree in a relevant technical field of study plus at least six (6) years experience – OR - High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing.
Required Experience and Skills:
- This role will require working on 8-hour shifts that are currently one common shift across the Operations team but will later rotate between 1st and 2nd shift on alternating weeks as the MACS Center is coming online and in full operations. Onsite presence is required five days a week. Occasional overtime work may be required based on business needs.
- Effective interpersonal and communication skills, both verbal and written.
- Excellent organizational skills to multi-task.
- Desire and willingness to learn, contribute and lead.
- Track-record of independent problem-solving.
- Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.
- A strong mechanical aptitude.
- Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.
Desired Experience and Skills:
- Experience working in a GMP clinical or manufacturing supply facility.
- Experience with GMP facility design, equipment start-up and/or qualification.
- Experience with small molecule drug substance and/or biologics process development.
- Experience in supporting compliance investigations and change management.
- Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents.
- Experience operating/maintaining pilot scale or prep lab scale equipment.
- Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)
- Experience with Potent Compound processing and containment systems (e.g., isolators), or clean room facilities.
- Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
- Experience working in an environment with an Automation System (DeltaV, PLC, etc.).
- Operations experience in pilot plant or manufacturing environment.
- Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.
- Lean Six Sigma Training / Certification.
