Posted

30+ days ago

Location

Portsmouth, NH

Description

 

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Strategic Operations Manager is responsible to lead manufacturing projects in partnership with the Manufacturing Leadership Team and capable to drive cross-functionally projects to completion. This person will work closely with Manufacturing Management to support the achievement of department goals, technology transfers, interdepartmental readiness and batch release requirements. The Strategic Operations Manager is SME for their area and general business processes. This person is key contributor to technology transfer and all activities directly support campaign readiness. The Strategic Operations Manager can effectively represent his functional area on site initiatives and capable interfacing with Lonza customers.

Key Responsibilities

  • The individual will manage and execute a collection of projects in addition to ensuring Manufacturing CAPA closures, Change Controls, LIRs, OTN and site deviations. The Strategic Operations Manager has responsibility for the planning, preparation, implementation and delivery of projects assigned. The individual works cross-functionally and in collaboration with internal support departments, customers and Manufacturing suites to develop or update internal policies, procedures or steps, identifies and escalate risks, communicates changes and plan for execution.
  • The Strategic Operations Manager is responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time performance.
  • This role may include the mentoring, management and oversight of other manufacturing Project Associates, specialists and temp labor.
  • Manage, track and ensure compliant/timely completion of deviation investigations in order to meet quality, safety, and lot release site deliverables.
  • Maintain positive working relationships with supporting departments, as well as customers to ensure good working relationships pertaining to deviation investigations are maintained.
  • Serving as member of the Asset Leadership Team (ALT) and reporting of departmental metrics.
  • Coordinate multiple departments and cross functional activities through strong meeting facilitation, conflict resolution, real-time troubleshooting, and prompt decision making.
  • Manage and prioritize documentation updates including SOPs, LQMs, Work Instructions and Batch Records.
  • Manage implementation, maintenance and periodic review of analytical instruments (e.g. FIT, NOVA, SoloVPE, Density Meters, Vicell, etc.).
  • MFG Lead for Internal Project team (IPT) and campaign readiness
  • Partner with Quality Assurance to develop, modify, implement and operate quality systems aligned with Lonza standards.
  • Drive continuous improvement activities, strategy development and delivery, as well as supporting organizational development and cultural leadership.
  • Serving as a member of the Manufacturing Leadership Team, the incumbent will be responsible for supporting the establishment and technical transfer of all operations associated within areas of responsibility.
  • MFG SME for Single-Use technology and support of Global alignment through Single-Use Network (SUN) Team.

Key Requirements

  • BS in Biotechnology, Biology, Chemistry, or equivalent. Preferred area of study:  Science related discipline
  • 7-10 years’ experience in related industry; GMP experience required, and API manufacturing experience preferred; project management experience required, 2-3 years supervisory/management experience preferred.
  • Project or other applicable schedule certificate required. Experience with 6S and Lean Manufacturing, Lean Six Sigma Green belt or black belt preferred, PMP certification preferred
  • Advanced technical knowledge of manufacturing operations (ideally all areas of manufacturing, but strong in some areas and ability to quickly learn other areas is acceptable). Thorough knowledge and understanding of batch records procedures, and other documentation required for manufacturing execution.
  • Working knowledge and experience with Quality Systems including deviations, change controls, OTNs, deviations; both the system (TrackWise) and the practical applications in operations.
  • Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
  • Experience in various Operational Excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, SMED etc.
  • Process transfers and campaign readiness experience
  • Demonstrated ability to manage medium to large sized projects within required timeframes. Experience with customer interactions, presentations
  • Ability to work inter-departmentally and with customers.
  • High level of suite specific operations and technical skills. 
  • Demonstrates role model behaviors for operating in a GMP manner.
  • Demonstrates role model safety behaviors
  • Strong written and verbal communication skills
  • Demonstrate ability for effective Planning, Organizing and Controlling competency
  • Fluent in Quality systems (document management, exceptions)
  • Proficient with MS Office (Project, PowerPoint, Excel)
  • Fluent in OE principles and tools, LEAN
  • Demonstrate sound decision making, considering broad scope of factors

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.