Associate Specialist – Modality Agnostic Chemistry Scaleup Operations (Alternating Shift)

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).

As required and in addition to support of current capital projects the Associate Specialist may provide direct support to other areas such as:

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.

• 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.
• A strong mechanical aptitude.
• Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.

• 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.

Hours:

1st shift: 8:00am - 4:00pm

2nd shift: 12:30pm-8:30pm (eventually will transition to 4pm - 12pm)

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.