Job Description
Sr. Specialist, Clinical Supply Operations (P3)
Position Description
The Sr. Specialist, Clinical Supply Operations (CSO) is responsible to support our clinical supply packaging & distribution operations at our company's Rahway, NJ site. This role will collaborate with a diverse range of stakeholders, subject matter experts, and customers both within and outside of Global Clinical Supply (GCS). Your responsibilities will be instrumental in driving innovative initiatives, ensuring operational efficiency, and maintaining compliance, all while supporting our commitment to business continuity. This role will report into Associate Director, Packaging & Distribution Support at our company's Rahway site.
Key responsibilities of the Sr. Specialist, Clinical Supply Operations include:
Process Execution | Continuous Improvement
- Supporting the operational efficiencies and initiatives of clinical supply operations; including packaging and distribution operations in Rahway, NJ.
- Assist in ensuring operational readiness for the expanding landscape of on-site clinical capabilities.
- Lead efforts to sustain inspection readiness by implementing standardized workstreams.
- Ensure efficient and compliant processes by taking ownership of the development and enhancement of standard operating procedures (SOPs) at both local and global levels.
- Effectively collaborate with other CSO nodes, optimizing interactions with partner groups such as Packaging, Label Room, Operations Planning, Quality, Master Planning, Bulk Manufacturing, and Analytical (for cleaning, swabbing, and investigations) to support business continuity and portfolio requirements.
- Establish strong partnerships with quality teams to ensure agility and responsiveness in meeting portfolio demands.
- Adaptively manage responsibilities and activities across CSO workstreams to support business objectives, leveraging Tier processes as appropriate.
- Collaborate with on-site upstream drug product manufacturing to implement integrated operations within clinical supply.
- Identify opportunities for innovation and process improvement, supporting necessary changes to enhance operational effectiveness.
- Lead or participate in area and process walkthroughs to assess compliance, identify process improvements, and execute corrective and preventive actions (CAPAs) ensure adherence to regulatory requirements.
- Serve as a Subject Matter Expert (SME), providing area and process overviews to stakeholders upon request.
- Author and/or participate in investigations of atypical events, clinical complaints, and CAPAs, as required.
- Ensure accurate documentation of SAP transactions, including pre‑execution and post‑execution reviews of batch documentation per established procedures.
Leadership | Communication
- Support daily Tier meetings to ensure effective communication and information flow-up and down through the organization.
- Provide ongoing feedback and coaching to employees to support performance, development, and accountability.
- Promote and maintain a culture of inclusion, consistency, and positive employee relations at both the team and site levels.
- Actively support the team in troubleshooting issues to minimize downtime and maintain product quality.
- Champion standard work to ensure consistent application of best practices across operations.
- Foster a strong and effective safety culture through visible actions, coaching, and clear prioritization of a safe environment.
Position Qualifications:
**Education Minimum Requirement: **
- Bachelor’s degree in engineering, Supply Chain, Business, or related field.
Required Experience and Skills:
- Minimum of 5 years of experience in production operations, technical project management, engineering, or management roles within the pharmaceutical industry, with a solid understanding of clinical supply needs, Good Manufacturing Practices (GMP), packaging, and distribution operations.
- Strong understanding of current Good Manufacturing Practices (cGMP), including compliance with FDA and EMEA regulations.
- Ability to operate effectively independently and collaboratively within teams
- Ability to manage multiple priorities and coordinate people/resources to meet a production schedule
- Outstanding decision-making skills and strengths in project management and team alignment
- Knowledge of cGMPs, data management, collection, and analysis
- Proficient in Microsoft Office (Word, Excel, etc.)
- SAP (or equivalent) experience strongly preferred
- Strong interpersonal, communication, organizational and problem-solving skills, coupled with the ability to engage and influence cross-functional stakeholders
Preferred Experience and Skills:
- Direct experience in pharmaceutical packaging and distribution operations is highly valued.
- Experience with cold chain clinical supply, including packaging and distribution operations.
- Knowledge of SAP systems and their application in supply chain management.
- Possession of Six Sigma certification (e.g., Green Belt or Black Belt).
- A demonstrated dedication to solving complex problems through innovative thinking and imaginative strategies.
- Understanding scheduling and capacity modeling to ensure optimal resource allocation.
- Demonstrated ability to drive change and improve operational effectiveness
**Required Skills: **
Clinical Supplies Management, Clinical Trials Operations, Driving Continuous Improvement, Good Manufacturing Practices (GMP), Logistics Coordination, Performance Support, Process Improvements, Production Planning, Regulatory Requirements, Standard Operating Procedure (SOP) Writing, Supply Chain Metrics
**Preferred Skills: **
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:
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.
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 salary range for this role is
$106,200.00 - $167,200.00
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.
You can apply for this role through https://jobs.merck.com/us/en (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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
05/11/2026
***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. **