Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

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.

The Durham Technical Operations Leader is based in the Hilleman Vaccine Manufacturing facility in Durham, reports to the Vice President of global Vaccines Science and Technology, and is also a member of the Site Leadership Team, with a dotted line accountability to the Durham Plant Manager. This individual will lead this multidisciplinary organization responsible for supporting the manufacture of critical, complex life-saving products through integrated support to site operations and quality teams.

The qualified candidate will guide the organization in providing direct support and expertise to routine commercial manufacturing as well as to in line technology transfers tied to facility expansions and upgrades. The Technical Operations Leader is accountable for ensuring that objectives are effectively achieved, consistent with Company requirements to ensure compliant, safe and reliable supply, equal employment, employee and environmental safety and health with harmonious employee relations and good relations in the local community.

Primary Accountabilities:

• The Site Technical Operations Leader aligns with local and global automation, engineering, EHS, supply chain and operations leaders for maintenance of functional excellence and standard approaches.

• The organization is responsible for all aspects of technical process and product support including problem resolution, process improvements, technology transfers, process monitoring, process maintenance to API, Pharmaceutical, Vaccine, and Biologics manufacturing.This includes interaction with health authorities, both written communication and inspections. The department structure includes dedicated support for each of 5 Integrated Process Teams (IPTs) in the operations areas, a centralized Validation organization, and a Process Support Laboratory with scale down model capabilities spanning a range of large molecule drug substance and drug product unit operations and characterization.

• Additionally, the Site Technical Operations Leader leverages the association with the global Large Molecule Technical Operations organization that provides external partner support, to collaborate on providing technical support to external partners within the region as a secondary responsibility.

• The Site Technical Operations Leader will typically lead a department of greater than 200 personnel and is responsible for ensuring the required competencies, talent management and development of people and is a member of the Site Leadership Team.

• They will create the environment in the group for collaboration across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a Boundary less Organization mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing in the flow of the core work.

Education Requirement:

• Bachelor's Degree in a related Science, Engineering or other Technical discipline.

Required Experience and Skills:

• A minimum of 10 years of experience in a comparable role and have experience contributing to the business at a directional, strategic level; ideal in a manufacturing, preferable Good Manufacturing Practice Setting.

• Biologics/Vaccines Operations management experience

• Equipment and process validation

• Understanding of mechanical/electrical/pneumatic processes

• Safety and Plant Policies and Procedures

• Knowledge of regulatory/code requirements to American and International Codes, Standards and Practices

• Recruitment and selection

• Employee Engagement/Relations

• Understanding of business and operations management models and their application

• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner

• Strong influencing and decision making skills

• Strong change management skills

• Effective conflict resolution

• Business acumen

• Strategy planning and development

• Risk management skills

• Progressive people management skills

• Ability to effectively manage complex projects across multiple disciplines

• Proven financial management skills

• Public Affairs facilitation and assessment skills

Preferred Experience and Skills:

• Six Sigma qualification

• Knowledge of automation

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R340072