Job Description

Description

The PDMB Regulated Bioanalytics Department is seeking a Senior Specialist SOPs & Training Management to join our Integrated Logistics & Sample Management group located at our company's state-of-the-art AdVAnce research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

Support Regulated BA organization through management of standard operating procedures (SOPs), and training documentation, ensuring staff have the tools and skills to perform job requirements

Education Minimum Requirement

• BA/BS with 7 years of experience, MA/MS with 3 years of experience, or Ph.D. Degrees may be in a variety of areas, including the biological sciences, computer sciences, medical technology, business management, etc.

Responsibilities

• Strong knowledge of document or training management systems. May also be involved in related new system releases or existing system updates/enhancements
• Creates, updates, and maintains SOPs, training documents, and departmental supporting documents
• Coordinates training assignments, curricula, and administration of our company training management systems
• Operates according to SOPs and safety principles
• Ensures SOP compliance (e.g., periodic reviews, revisions, and establishment of new SOPs)
• Demonstrates good documentation practices (GDP) in all forms of documentation
• Plans, tracks, and ensures all aspects of SOPs & Training deliverables are progressing according to specifications and timelines
• Communicates SOP and training information across various functional areas, support functions, and alliance partners
• Follow issues through to resolution and ensure all key stakeholders are informed of outcomes
• Builds and maintains relationships with cross functional stakeholders
• Builds out training curriculum across the PDMB organization providing staff the tools and skills to perform job requirements
• May participate on project or process improvement teams to drive enhancements

Required Experience & Skills

• Strong written and verbal communication skills
• Strong organization skills and attention to detail
• Ability to perform under pressure and in a changing environment
• Operates under minimal supervision to perform general tasks (e.g., data input and output)
• Ability to establish good working relationships and engage across functional teams
• Ability to hold others accountable for delivery

#ProjectADVANCE

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

$104,200.00 - $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 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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Ability to Work Under Pressure, Ability to Work Under Pressure, Adaptability, Assay, Audits Compliance, Business Administration, Cell-Based Assays, Clinical Testing, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Immunoassays, Information Technology (IT) Infrastructure, Management Process, Oral Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Polymerase Chain Reaction (PCR), Process Improvement Projects, Process Improvements, Project Management, Proteomics, Regulatory Affairs Management {+ 5 more}

Preferred Skills:

Job Posting End Date:

09/24/2025

*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:R365705