Laboratory Manager, Quality Control
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Under the direction of the Associate Director, the Laboratory Operations Manager is responsible for enabling efficient execution of material testing for Merck’s Manufacturing Division in a safe and compliant manner, thereby contributing to the Merck’s ability to supply product to patients.
The Quality Control Laboratory Manager will take ownership of several analytical assays, including communication with laboratory technicians, product stakeholders and support groups. Specific duties may include the following:
- First line quality/operations supervisor with a team of individual contributor production direct reports
- Ensure that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with Merck, 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
- 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, procedure 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 quality, 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 – Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need.
- Supply – Support Tier. Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).
- Continuous Improvement – Accountable for developing a Merck Production System (MPS) and continuous improvement culture while achieving MPS 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) have business acumen and understand how they may impact business finances.
- People Management – Responsible for creating and sustaining a highly engaged workforce through utilization of Merck 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.
- 1Identify 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
- Ability to develop and lead others
- Ability to be flexible and understand risk
- Continuous improvement
- Conflict resolution
- Leadership style – adaptive; high performance coaching; servant leader
- B.S/B.A. or M.S in Biology, Microbiology, Virology, Biochemistry, or associated field
- 3 years post-degree laboratory, manufacturing, or quality control/assurance experience.
- Minimum (2) years’ experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)
- Minimum (2) years’ experience in heavily regulated industry (ex; FDA, military, nuclear and pertro-chemical)
- Demonstrated knowledge of Lean
- Demonstrated experience of interacting with site, divisional or regulatory audits
- Customer service mentality and process improvement experience
- MS in a science-related discipline
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Quality Lab Related
Employee Status: Regular
Number of Openings: 3
Shift (if applicable): 1st
Hazardous Materials: Yes: BSL1, BSL2
Company Trade Name: Merck