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 earn 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 substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.
As the team finishes design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take 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 substance manufacturing/sterile supply in regulated, clean room environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.
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, commissioning, qualification through licensure and ramp up of facility.
Leads and provides input into continuous improvement opportunities.
Accountability: Operational Leadership
Ensure that Shift(s) objectives are achieved while reliably supplying 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.
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 - 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 judgment 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 Production System and continuous improvement culture while achieving the 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 – Responsible for creating and sustaining a highly engaged workforce through utilization of our company's 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
Required: High School Diploma or equivalent.
Preferred: Bachelor's Degree in Business Administration, Science, Engineering or another technical field
Minimum (4) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
The position will initially be Mon-Fri, day shift. Shift schedule may change when operations starts, expected in 2023.
Successful completion of TB blood test and chest x-ray are required
2 years’ experience in relevant manufacturing or processing (aseptic/sterile, bulk, cell culture, etc.)
Demonstrated knowledge of Lean/Six Sigma
Demonstrated experience of interacting with site, divisional or regulatory audits
Ability to develop and lead others
Ability to be flexible and understand risk
Leadership style – adaptive; high performance coaching; servant leader
Note: This job description is not intended to be all-inclusive. Employee may perform other related duties to support the organization.
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.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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