Associate Specialist, Operations (Onsite)

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 MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies /capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure .- Responsibilities of the Operations Specialist include the following : -

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The Operations Specialist role at the Associate Specialist level will serve as a n 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. The y will serve as a team member for the MACS Center c onstruction and s tartup p hase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network . - -

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As the facility is currently under construction, t he 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 e quipment 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 s uite 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. -

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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) - year s experie nce - OR - High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing. -

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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 . -
  

• T his 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. --
  

Desired Experience and Skills: -

• Experience working in a GMP clinical or manufacturing supply facility.- -
  

• Experience with GMP facility design, e quipment 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 document s. -
  

• 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. -
  

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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:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$70,500.00 - $110,900.00

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

Search Firm Representatives Please Read Carefully-
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.-

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Accountability, Accountability, Applied Engineering, Assembly Operations, Biochemistry, Chemical Engineering, Communication, GMP Compliance, Good Manufacturing Practices (GMP), Hazard Analysis, HR Programs, Machinery Operation, Management Process, Mechanical Apptitude, Operations Support, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Technologies, Production Efficiencies, Production Process Development, Production Scheduling, Raw Material Sampling, Risk Control Assessment, Safety Protocols {+ 5 more}

-Preferred Skills:

Job Posting End Date:
10/7/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R365921