Job Description

This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of HPV drug substances.

As the team finishes the startup of the facility, the Operations Manager will play a critical role in supporting the Bulk Facility team, partnering with internal stakeholders, and building the operations team who will have operational ownership of the facility. Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production. The ideal candidate for this role will be an energetic leader with strong interpersonal, leadership, collaboration skills, and has demonstrated the ability to meet immediate business objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.

Key Responsibilities for a Drug Product Operations Manager

Accountability | Project Support

• First-line operations supervisor with a team of individual contributor production direct reports

• Supports project team as operations leader through licensure, and ramp-up of the facility.

• Leads and provides input into continuous improvement opportunities.

Accountability | Operational Leadership

• Ensure that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment, and safety, not in that order.

• Tactical and strategic shift(s) management, including collaboration with indirect staff.

• Promote the behaviors and principles that drive continuous improvement.

Additional

• Typically, coordinates and supervises the daily activities of individual contributors.

• Sets priorities for the team to ensure task completion, coordinates work activities with other supervisors.

• Decisions are guided by policies, procedures and business plan | Receives guidance and oversight from Operations Associate Director and Director

• Interprets client and/or customer needs and assesses requirements.

• Applies supervisory skills to improve efficiency and accomplish operational objectives within own unit.

• Identifies and resolves standard day-to-day technical and operational problems within own unit.

• Sets priorities for unit to meet daily deadlines; develops plans to meet short-term objectives.

• Works within budgetary/ financial objectives set by Director.

• Makes decisions guided by policies and standard operating procedures that impact the efficiency and effectiveness of own unit.

• Compliance - Creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business | Establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement | Review and approve compliance documents, as per procedures or need.

• Supply/Support Tier - Exercise judgment and decision making to ensure a quality product is reliably produced while managing cost | Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.)

• Continuous Improvement - Accountable for developing a Company Production System (CPS) and continuous improvement culture while achieving CPS Targets and business results for the Shift(s) | Develop strategic initiatives related to the manufacturing process, equipment, and human resources in support of long-range operating plans | Report Shift(s) monthly metrics and any action plans to address gaps to the Associate Director and/or Director | Identify, prioritize, and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability, and eliminate waste.

• Financial Stewardship – Accountable for meeting the Shift(s) operating budget and continuously reducing cost | Ensure members of the Shift(s) have business acumen and understand how they may impact business finances.

• People Management – Creating and sustaining a highly engaged workforce through the utilization of Company Leadership Behaviors and Inclusion | Provide coaching on professional development and career paths | Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation | Provide feedback and input on performance evaluations for indirect staff | Support Talent Management.

• Direct, coordinate, provide guidance and counseling to group leaders to assure optimum quality and quantity of finished products.

• Keep all team members informed on current policies and procedures, and all other plant communications.

• Enforce all prescribed safety rules and regulations and take prompt corrective action concerning potential safety hazards.

• Provide leadership in establishing and maintaining a high efficiency and productivity level from the team members, while maintaining a focus on Safety First and Quality Always

• Identify root causes of manufacturing issues and implement corrective action to minimize downtime with a focus on Safety, Quality, Delivery and Cost, in that order.

• Actively develop members to obtain maximum potential.

• Support and lead/participate in the Hoshin process and advocate for, and continually strive to achieve our Vision.

Education

• High School Diploma AND at least Six (6) years in a manufacturing, technical, support, or Military role. OR

• Bachelor’s degree in a technical field AND at least four (4) years in a manufacturing, technical, support, or Military role.

• Bachelor's degree and two (2) years of experience in a direct GMP, biotechnology, and manufacturing setting.

Required Experience and Skills

• Ability to develop and lead others

• Ability to be flexible and understand the risk

• Continuous improvement

• Conflict resolution

• Leadership style – adaptive; high-performance coaching; a servant leader

Preferred Experience and Skills

• Two years in relevant Drug Product manufacturing or processing

• Demonstrated knowledge of Lean/Six Sigma

• Demonstrated experience of interacting with the site, divisional or regulatory audits

Schedule Requirements

• The position will initially be Day Shift or Night Shift working 12 hours a 2-2-3 Schedule. Shift is dependent on the business need.

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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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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

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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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day, 3rd - Night

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

12/25/2024

*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:R326568