Manager, Drug Substance Operations

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.

As the team finishes the 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.

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, commissioning, 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

• 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 will initially be Day Shift M-F, transitioning to 2nd shift M-F when Operations begin (projected Late 2Q/3Q2023).

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., Rahway, 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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #VETJOBS #EBRG MSJR

Residents of Colorado

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Residents of Colorado:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Requisition ID:R228946