Assoc. Spclst, Prep Lab Operations Specialist (Onsite)

MSD Malaysia; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Specialist - Prep Lab Operations to support the Prep Lab team, interfacing with scientists to enable early clinical studies and scale-up of new chemistries.

The role emphasizes GMP compliance, collaboration with Safety/Quality, and continuous process improvements in a fast-paced lab environment. Onsite five days a week with possible second shift support.

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related field with 1 year of relevant experience OR
• Associate degree in a relevant field with 6 years of experience OR
• High school diploma with 8 years of relevant experience in pharma/chemical manufacturing.

Responsibilities

• Support Prep Lab operations for API/Drug Substance scale-up and development.
• Collaborate with scientists and project teams to meet manufacturing needs.
• Maintain GMP readiness and ensure regulatory compliance.
• Lead process improvement initiatives to enhance efficiency.

Skills

Interpersonal communication

Organizational skills

Problem solving

Cross-functional collaboration

Mechanical aptitude

Technical writing

Shift work adaptability

Proactive learning

Education

Bachelor’s degree in Chemical Engineering or related field

Associate degree in Process Technology or related technical field

Tools

Pilot plant equipment

GMP/cGMP documentation

MS Office (Word, Excel, PowerPoint)

Job description

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

• 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

• 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.

ERP Required Skills

• Equipment Maintenance
• Good Manufacturing Practices (GMP)
• Manufacturing Technologies
• Multitasking
• Process Optimization

Spreadsheets

Teamwork

Preferred Skills

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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: EEOC Know Your Rights EEOC GINA Supplement.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

The salary range for this role is $71,900.00 - $113,200.00. 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 https://jobs.merck.com/us/en/compensation-and-benefits.

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: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.