Job Description
Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a “Safety First, Quality Always” mindset, striving for continuous improvement, and earning our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.
This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substances, drug products, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.
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 substance manufacturing 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 Substance Manager
Accountability | Project Support
First-line operations supervisor with a team of individual contributor production direct reports
Supports project team as operations leader through start-up, qualification 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
Successfully maintain Aseptic Gowning qualifications (Aseptic gowning includes all skin and hair covered).
Candidate must pass a TB Blood and Chest X-Ray prior to start date.
Preferred Experience and Skills
Minimum two years in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)
Demonstrated knowledge of Lean/Six Sigma
Demonstrated experience of interacting with the site, divisional or regulatory audits
Schedule Requirements
The position is for 2nd Shift - 2pm - 10:30pm - Overtime required upon request
Residents of Colorado
Click here to request this role’s pay range.
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Required Skills:
Adaptability, Adaptability, Aseptic Manufacturing, Business Management, Business Planning, cGMP Compliance, Communication, Data Analysis, Employee Performance Standards, Global Manufacturing, GMP Compliance, Good Manufacturing Practices (GMP), Interpersonal Relationships, Inventory Management, Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Operations Management, Packaging Operations, People Leadership, Process Engineering, Process Improvements, Production Management, Production Scheduling {+ 3 more}Preferred Skills:
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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:
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.
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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”.
The salary range for this role is
$94,300.00 - $148,500.00This 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
2nd - EveningValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
11/19/2025*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.