Requisition ID: MAN006059
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 patients on time, every time, across the globe.
Objective of position:
An IPT (Integrated Process Team) Lead provides support and expertise to the IPT in support of manufacturing and distribution. The individual collaborates with appropriate internal and external partners to ensure IPT actions meet or exceed regulatory and company standards. There is collaboration with site leadership to determine optimum systems and processes leading to stable and effective results. The IPT Lead directs teams to ensure business goals and budgets expectations are met. An IPT Lead leads by example and displays strong coaching, MPS principles, inclusive behaviors and best practices.
Job Summary: An outline of job responsibilities
The position will manage the activities within the IPT and collaborate with Regulatory Affairs, Quality, EHS, Engineering, BTS, ATS and HR.
Essential functions of IPT Lead: This lists details tasks, duties and responsibilities.
Some duties may include but are not limited to the following:
Specific to IPT, responsibility for comprehensive management of all activities required to successfully support and manufacture product
Performance manage individual contributors and managers
Ensure compliance to corporate, site and departmental procedures associated with the manufacturing of product, and ensuring team is trained on new or revised processes or procedures
Review and approve Quality Notifications
Author, review and approve SOPs
Serve as subject matter expert for product release matters
Lead and/or participate in project management initiatives as appropriate to IPT
Direct support of regulatory inspections and audits
Direct support of validation activities and all other associated Quality related activities pertaining to the IPT
Identify and resolve technical and operational issues; collaborate with others to resolve issues
Accountable for overall performance of IPT
Implement IPT plans and priorities based on division scorecard
Manage and forecast budget of IPT
Competencies: Knowledge, skills and abilities required for this position
Manages individual contributors (professional employees) and/or managers
Contributes to the performance results of a department
Adapts departmental plans and priorities to address resource and operational challenges
Decisions are guided by policies, procedures and business plan
Provides technical guidance to employees, colleagues or clients
Anticipates and interprets client and/or customer needs to identify solutions
Proven ability to use scientific problem solving and lean manufacturing principles to solve complex issues
Working knowledge of regulatory requirements in accordance with cGMP and/or USDA manufacturing operations
Proven project management skills
Proven people development and coaching skills
Excellent communication skills; able to communicate company and site strategies to direct reports and IPT employees
Working knowledge of aseptic techniques and aseptic operations
Working knowledge of steam in place, clean in place, clean out of place and steam out of place
Working knowledge of cell culture, virus propagation, and bacterial propagation and downstream processing
Proficiency in computer systems and applications
Must be able to lead in a team-based empowered culture
Ability to work independently and effectively with peers; display strong interpersonal and organizational skills
Knowledge and the ability to coach MPS/Lean methodology
Education Minimum Requirement:
Bachelor’s degree in Life Science field or business-related field
Required Experience and Skills:
8 years of relevant experience in the vaccine and/or pharmaceutical industry
5 years management experience (people, budget, organization and results)
Excellent team building skills that focus on mentoring and coaching
Excellent communication skills
Demonstration of high analytical and logical problem-solving abilities
Working knowledge of aseptic techniques
In-depth knowledge of cGMP’s
Strong knowledge of blending, filling and packaging materials, principles and operating systems
Preferred Experience and Skills:
Experience in SAP and inventory control
LSS Green Belt or higher (LL2/LL3)
Knowledge of kata and other lean coaching tools
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.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to email@example.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.