Assoc. Spclst, Prep Lab Operations Specialist (Onsite)

Merck•Rahway, NJ

7d•$71,900 - $113,200•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 operations experience and a strong understanding of engineering fundamentals. The Associate Specialist - Prep Lab Operations position will report to the Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. This position will be a member of the Prep Lab team which is responsible for interfacing with scientists and Project teams who are manufacturing API (Active Pharmaceutical Intermediates) and DS (drug substance) to enable early clinical studies, scaling up new chemistries, and exploring new technologies. The Associate Specialist - Operations role involves working directly with the Prep Lab lead supporting scientific teams who are preparing for manufacturing API and DS to supply material for both development work and clinical studies in our kg scale (Prep Lab) facilities. This work involves collaborating with teams to understand their equipment and processing needs, supporting them during manufacture if required, and ensuring that the facility is kept GMP ready at all times. The Associate Specialist will also be expected to work with Safety and Quality partners to ensure that the facility is compliant with all applicable regulations. And the successful candidate will lead process improvement initiatives to enhance the efficiency and effectiveness of the overall Prep Lab operations. As required by the business and in addition to support of the Prep Lab facility, the Associate Specialist will provide direct support of other areas of Chemical Engineering Research & Development such as: Modality Agnostic Chemistry Scaleup (MACS): The MACS Center is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing pilot plant currently under construction in Rahway, New Jersey. Like the SSO, MACS is a GMP facility in the PR&D organization and shares its mission with the SSO but is focused on potent, cross-modality processing. 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.

Requirements

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.
Onsite presence is required five days a week.
Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific or technical field plus one (1) year relevant work experience
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
High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical, Food Processing, or Manufacturing.
Equipment Maintenance
Good Manufacturing Practices (GMP)
Manufacturing Technologies
Multitasking
Process Optimization
Spreadsheets
Teamwork

Nice To Haves

Experience working in a GMP clinical or manufacturing supply facility.
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 with Potent Compound processing and containment systems (e.g., isolators), and/or clean room facilities.
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.
Preferred Skills

Responsibilities

Interfacing with scientists and Project teams who are manufacturing API (Active Pharmaceutical Intermediates) and DS (drug substance) to enable early clinical studies, scaling up new chemistries, and exploring new technologies.
Working directly with the Prep Lab lead supporting scientific teams who are preparing for manufacturing API and DS to supply material for both development work and clinical studies in our kg scale (Prep Lab) facilities.
Collaborating with teams to understand their equipment and processing needs.
Supporting teams during manufacture if required.
Ensuring that the facility is kept GMP ready at all times.
Working with Safety and Quality partners to ensure that the facility is compliant with all applicable regulations.
Leading process improvement initiatives to enhance the efficiency and effectiveness of the overall Prep Lab operations.
Providing direct support of other areas of Chemical Engineering Research & Development such as Modality Agnostic Chemistry Scaleup (MACS) and Small Scale Organics Pilot Plant (SSO).