Associate Director Operations

Merck & Co, Inc   •  

Millsboro, DE

Industry: Professional, Scientific & Technical Services

  •  

8 - 10 years

Posted 67 days ago

This job is no longer available.

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

Qualifications

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
  • Advanced Degree
  • LSS Green Belt or higher (LL2/LL3)
  • Knowledge of kata and other lean coaching tools

Requisition ID: MAN006058