Assoc. Spclst, Prep Lab Operations Specialist (Onsite)

Job Description

Job Description:

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.

Primary Responsibilities of the Associate Specialist - Prep Lab Operations include the following:

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.

Additional Responsibilities of the Associate Specialist Operations include the following:

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.

Education Minimum Requirement:

• • Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific or technical 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, Food Processing, or Manufacturing.

Required Experience and Skills:

• • 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.
  • This role will require working on 8-hour shifts that may occasionally be 2nd shift to support batch processing.
  • Occasional overtime work may be required based on business needs.

Desired Experience and Skills:

• • 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.

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Required Skills:

Preferred Skills:

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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

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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