Job Description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our ability to excel relies on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to work with talented and dedicated colleagues while developing and expanding your career.

We are seeking an Associate Director within the Durham Operations team. Reporting to the Director of Operations, the Associate Director in Vaccine Manufacturing area is accountable for the oversight of Manufacturing Operations, at the Durham Vaccine Manufacturing Facility, while actively supporting, participating in and embracing an empowered team culture.

Responsibilities

General Profile

* Manages individual contributors (professional employees) and/or supervisors

* Contributes to the performance and results of a department

* Adapts plans and priorities based on departmental budget and profit plan to address resource and operational opportunities

* Decisions are guided by policies, procedures and business plan; receives guidance from manager

* Provides technical guidance to employees, colleagues or clients

* Anticipates and interprets client and/or customer needs to identify solutions

Business Expertise

* Applies management skills to align staff activities with department objectives

Functional Expertise

* Guide the team and others by providing direction and guidance

* Ensure compliance to Corporate, Site, and Departmental procedures associated with the manufacturing of vaccine product, and ensuring team is trained on new or revised processes or procedures

* Review and approve Quality Notifications (QNs)

* Author, review, and approve SOPs

* Take on project management opportunities, by directing and participating in process improvement, learning events, or business initiatives, as guided or approved by Operations management

* Determine staffing needs and hire to meet those demands

* Serve as the Subject Matter Expert for all release related matters

* Interact with Vendors and Merck Supplier Development and Procurement Management for issues associated with incoming components

* Review and approve Vendor Change Notifications

* Review and approve BOM changes

* Review and approve Master Batch Records

* Review and approve Operation, Technology, or Automation protocols

* Participation in Kaizen events.

* Direct regulatory inspections and audits.

* Direct validation activities and all other associated Quality functions.

* Other duties as requested by Management

Problem Solving

* Identifies and resolves technical and operational problems; works with peers to resolve problems that cross into inter-related units

Impact

Influence

* Explains difficult concepts and persuades others to adopt a point of view.

* Communicates information, asks questions and checks for understanding

Accountability

* Accountable for the performance and results of a unit

Decision Making

* Makes decisions guided by policies and procedures that impact the units ability to meet performance objectives

* Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Strategic Planning

* Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

Resource Management

* Forecasts resource needs; manages allocated budget

Required Education, Experience, & Skills

* Bachelor degree in Engineering, Science or related field AND at least eight (8) years working in a Manufacturing, Pharma, Biotech and / or Vaccines Industry in operations, planning, or functional support role(s) OR

* Master degree in Engineering, Science or related field AND at least six (6) years working in a Manufacturing, Pharma, Biotech and / or Vaccines Industry in operations, planning, or functional support role(s)

* Strategic and effective communication skills with the ability to present complex data sets to diverse audience with varying business acumen

* Demonstrated technical expertise during regulatory inspections and audits

* Demonstrated project management and analytical skills

* Proficient in Microsoft Office, including Excel and PowerPoint

Preferred Experience & Skills

* Demonstrated experience leading teams (direct supervisor or project teams)

* cGMP experience in a full-scale pharmaceutical vaccine manufacturing environment

* Lean/six sigma and change management methodologies

* MRP/ERP systems such as SAP

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 thats 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No Travel Required

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R108806