Senior Specialist – Stability & Sample Management

Job Description

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities Validation and Compliance (ECVC) department of our Research Laboratories Division is seeking applicants for a for a Senior Specialist position available at the Rahway New Jersey research facility.

The Stability and Sample Management Senior Specialist will work as a part of the integrated Stability Operations team and drive a culture of quality and operational excellence across the global analytical network. The Stability and Sample Management Senior Specialist will oversee and support GMP stability and sample management logistics in collaboration with our analytical scientists.

The key responsibilities of this role will include:

• Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence.

• Receive analytical samples from partner groups according to established procedures.

• Aliquot prepare and label analytical samples for distribution to on-site testing laboratories or shipment including the coordination of international shipments.

• Manage and maintain a suite of GMP stability chambers in a state of permanent inspection readiness.

• Provide technical supervision to a small group of specialists

• Manage analytical samples for pipeline stability studies.

• Maintain accurate records including sample inventory and sample chain of custody leveraging digital systems (e.g. LIMS Benchling electronic notebook eLogs).

• Stability study builds in LIMS and data management.

• Perform deviations and investigations create Change Management records (where necessary) manage GMP documentation including Standard Operating Procedures (SOP).

• Support logistical requirements for capital expansions including facility/ CTU requirements

  and capacity planning.

• Continuous improvement to maintain state-of-the-art stability infrastructure to meet Global

  compliance standards.

Candidates should be able to function independently and be able to collaborate in a dynamic integrated multidisciplinary team environment. Effective communication skills eagerness to adapt and learn and a desire to conduct research and influence the field are essential attributes. As a member of our team you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

Education Requirements:

• M.S. with 3 years of post-degree relevant industry experience or B.S. with 7 years of experience

Required Experience and Skills

• An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives.

• Proven track record of strong technical and innovative problem solving

• Desire and ability to learn new concepts outside of core expertise and training

• Excellent communication skills demonstrated creativity and effective interpersonal skills.

• Experience working within a GMP environment.

• Understanding of GMP policies and procedures.

• Related industry experience supporting management of analytical samples

Preferred Experience and Skills

While not required experience in one or more of the following areas is beneficial.

• Demonstrated commitment to diversity and inclusion.

• Experience leading a team for a common goal.

• Experience in Auditing and Compliance within pharmaceutical industry including change management and deviation management.

• Experience supporting internal and external quality audits.

• Experience supporting logistical requirements for capital expansions including facility/ CTU requirements

  and capacity planning.

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Required Skills:

Preferred Skills:

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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 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

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 employees 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 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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