Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

We have an exciting opportunity for a Senior Specialist to join the operations team for a capital project start-up in Durham, North Carolina. The facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. This position requires the ability to work independently with moderate to minimal supervision, produce/complete various assignments requiring analytical ability, demonstrate independent judgment, creativity and problem-solving skills. This role also requires strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers, above site partners, vendors) to support these initiatives. The Senior Specialist must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.

*This is a full-time position working Monday through Friday, dayshift (normally 8:00am-4:30pm)

*Applicant must complete and be medically cleared for BCG medical clearance requirements:

questionnaire, blood test, chest x-ray

Position Description:

The duties of Senior Specialist, Operations include but are not limited to:

• Lead production schedule across operations (e.g. media, drug substance, drug product, etc.). Interface with site planning and other IPT scheduling teams

• Assist with facilitation of Project and site Tier meetings and help manage the operations project portfolio.

• Guide cross-functional teams to advance project goals.

• Manage area metrics/KPIs/schedule

• Assist in developing operations controls and metrics to display the overall health of the project.

• Develop and implement plans in partnership with other internal departments and above site and external contacts on different projects and initiatives.

• Communication skills must be effective to interact with internal/external customers to manage projects, assignments, and workflow.

• The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best comprehend and resolve it at the root cause.

Key Competencies

• Critical thinking, problem solving and decision-making skills

• Ability to see big picture and identify improvements aligned with business objectives.

• Comprehension of program and project management fundamentals including indirect management skills.

• Prioritization, planning, organizing and delegation skills.

• Working with peers, management and both internal and external partners.

• Conflict management

• Customer focused

• Self-directed

• Communication with diverse audiences

• Strategic end to end thinking

Education Qualifications:

• Bachelor’s degree in an Engineering or Science related field with at least five (5) years of experience in manufacturing/operations in a regulated industry OR

• Master’s degree in an Engineering or Science related field with at least four (4) years of experience in manufacturing/operations in a regulated industry

​

Required Experience:

• Experience with Project Management and/or indirect leadership.

Preferred Qualifications:

• Experience working in a pharmaceutical, biotech or vaccines manufacturing environment

• Scheduling experience

• Lean Six Sigma Green Belt or Black Belt Certification

• Experience with aseptic processing operations such as cell culture, filling, and/or lyophilization

• Experience authoring technical documents such as Standard Operating Procedures (SOPs) and change requests within a current Good Manufacturing Practices (cGMP) context #EBRG #VETJOBS MSJR

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

$94,300.00 - $148,500.00

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Cleaning Supplies, Cleaning chemicals, raw materials, biohazard waste

Required Skills:

Adaptability, Analytical Problem Solving, Applied Engineering, cGMP Compliance, Communication, Data Analysis, Decision Making, Inventory Management, Lean Six Sigma Continuous Improvement, Management Process, Manufacturing Technologies, Personal Initiative, Process Improvements, Process Optimization, Production Planning, Production Scheduling, Training and Development, Vaccine Manufacturing

Preferred Skills:

Job Posting End Date:

07/3/2025

*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:R354638