Job Description

Senior Specialist, Process Chemistry

The Prep Lab and Small Scale Organics (SSO) Pilot Plant are Good Manufacturing Practices (GMP) facilities within the Process Research and Development (PR&D) organization, which are located in Rahway, New Jersey and serve as a node for small molecule drug substance clinical manufacture while facilitating critical internal experience of new technology/processes and training opportunities.

We are seeking a Process Chemistry Senior Specialist to join our Process Chemistry group within SMPRD. This role will be integral as a process team member and technical mentor, contributing to the GMP clinical manufacturing and commercial process demonstrations of multi-modality Drug Substances [including small molecules, macrocyclic peptides, and bioconjugates] within our Prep Lab and SSO facilities. The ideal candidate will possess substantial scientific, technical, and operational expertise to support batch processing, lead process development initiatives, conduct compliance investigations, and author GMP documentation. Additionally, the Senior Specialist will play a crucial role in guiding and mentoring other staff in the Prep Lab as needed.

Responsibilities of the Senior Specialist – Process Chemistry include the following:

In this role, the primary responsibility of the successful candidate will be to conduct extensive research and analysis to identify the most effective chemical processes, optimizing reaction conditions, and ensuring the scalability and reproducibility of our processes. As a result, the ideal candidate must have extensive process chemistry experience, be highly self-motivated, have excellent written and oral communication abilities, collaborate effectively, and be able to demonstrate adaptability in a fast-paced, dynamic research environment.

In addition, the selected candidate will ensure compliance with Safety and Environment (S&E) and GMP requirements while collaborating with Prep Lab and SSO partners for batch processing. As a vital member of the process chemistry team, the candidate will promote a collaborative and innovative culture, working closely with engineers, chemists, and compliance representatives to guarantee the quality and safe delivery of clinical supplies. The successful candidate will train and upskill Process Chemistry members on compliance topics, including GMP use of Signals, relevant SOPs for PL/SSO operations, and the specific GMP documentation required for batch processing and release.

Specific responsibilities will include the following:

• Design and develop efficient processes for clinical campaigns, this involves extensive reaction design and optimization to ensure the scalability and reproducibility of our processes.

• Support chemists during process development by contributing to experimental design, data analysis and interpretation of results.

• Collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and enable flexibility and speed of the Company’s pipeline.

• Prepare, review, and/or approve GMP Documentation as appropriate.

• Author/Approve Standard Operating Procedures.

• Prepare for and support batch processing readiness and execution activities.

• Provide regular feedback to peers to promote a continuous improvement mindset and collaborate with all building staff to share and align on best practices.

• Identify opportunities to improve building efficiency, compliance, and safety.

Education

• B.S or M.S. in chemistry, chemical biology, medicinal chemistry, or related scientific discipline with ten (10) years’ experience or a Ph.D. in related fields with 2+ years’ experience.

Requirements

• Small molecule drug substance and/or biologics process development and scale-up, moving from laboratory to pilot scale.

• Mechanical aptitude and familiarity with chemical process development and process equipment.

• Extensive Prep Lab and SSO experience.

• Familiarity with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.

• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.

• Ability to build effective work relationships with a diverse workforce.

• Excellent time management and organizational skills.

• Desire and willingness to learn, contribute, and lead in a dynamic production environment.

• Track-record of independent problem-solving.

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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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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.

Learn more about your rights, including under California, Colorado and other US State Acts

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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$114,700.00 - $180,500.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Preferred Skills:

Job Posting End Date:

05/13/2025

*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.