Senior Specialist, Stability Operations

Job Description

Senior Specialist, External Capabilities Validation & Compliance (Stability Operations), Analytical Research & Development

The Analytical Research & Development (AR&D) Stability Operations & Compliance department of our company Research Laboratories Division is seeking applicants for a stability operations senior specialist position available at our US research facilities. 

 

The Stability Operations Senior Specialist will work as a part of the integrated Stability Operations & Compliance team and drive a culture of quality and operational excellence across the global AR&D network. The Stability Operations Senior Specialist will oversee and manage GMP stability studies and logistics for our large molecule portfolio in collaboration with our AR&D scientists.

The key responsibilities of this role will include:

• Management of GMP stability studies, including detailed planning, coordination across networks, and implementation of stability studies for the large molecule portfolio, in accordance with all applicable regulatory requirements.

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

• Evaluation of stability data, including statistical analysis and trending, investigating out of specification stability results, and communication with integrated project teams for biologics, vaccines, and/or devices.

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

• Analytical sample management support for large molecule pipeline stability study activities including: aliquoting, labeling, distribution to testing laboratories, and shipping.

• Execute deviations and investigations, Change Management records, manage GMP documentation including stability protocols, Standard Operating Procedures (SOP), and GMP data management.

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 Minimum Requirements (standard for each level):

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

Required Experience and Skills:

• Knowledge and understanding of regulatory guidance and quality standards applicable to stability testing and shelf-life determination of vaccines and/or vaccines.

• Working knowledge of analytical methods and GMP policies and procedures.

• Experience working within a GMP environment.

• 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.

• Related industry experiences supporting management of stability studies.

 

Preferred Experience and Skills:

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

• Experience leading teams for a common goal.

• Experience supporting internal and external quality audits.

• Experience with LIMS.

#AR&D

#eligibleforerp

Required Skills:

Accountability, Accountability, Adaptability, Analytical Chemistry, Clinical Data Interpretation, Communication, Data Analysis, Diversity and Inclusion (D&I), Experimentation, GMP Compliance, Immunizations, Lab Equipment Maintenance, Laboratory Management, Learning New Concepts, Manufacturing Compliance, Operational Excellence, Personal Initiative, Quality Auditing, Quality Management, Regulatory Compliance, Regulatory Requirements, Research Consulting, Reviewing Literature, Scientific Research, Statistical Analysis {+ 4 more}

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:

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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 salary range for this role is

$104, $163,900.00

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

11/14/2025

*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:R372374

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