Manufacturing Project Associate - Tech Transfers

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. 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 Manufacturing Project Associate Level II is an intermediate level position for an individual with strong technical manufacturing knowledge and proven project experience. As a level II, the individual is responsible for medium to large sized suite and process specific projects and projects that span across suites and/or the entire Manufacturing organization. The individual 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.

The Project Associate supports by working cross-functionally and in collaboration with internal support departments, vendors, and Manufacturing suites to implement new systems, technology and/or procedures, update/create associated documentations and provide essential trainings. The individual will be expected to manage a number of projects at various stages of completion; managing priorities and ensuring on time and quality delivery of all assigned projects. In this level, individuals may become introduced to more customer and campaign focused responsibilities, including IPT/JPT and pre-campaign initiatives.

Key Responsibilities

  • Collaborate with the Readiness team(s) and Manufacturing Management to identify and prioritize Mfg. improvement projects focused on reliability, efficiency, quality, safety and volume increase.
  • Manage and prioritize multiple medium to large sized projects
  • Own and manage corrective and preventative action (CAPA) deliverables to ensure timely closure.
  • Own and manage Mfg. change controls, driving these to hit timelines.
  • Develop detailed project plans and cost benefit analyses
  • Create lump sums and process orders, as needed.
  • Work cross-functionally with supporting departments, including Engineering, MSAT, Sourcing, Validation, Documentation, QA and other applicable groups to implement.
  • Schedule and lead internal and external meetings, as needed to aide in scoping, design, decision making, etc.
  • Work directly with vendors to procure new consumables or equipment.
  • Report milestone project progress and escalate barriers to progress through the daily management system or associated work stream.
  • Provide effective trainings for manufacturing staff (to include 4 shifts) related to any new or revised procedures, systems or equipment (to include hands on training as appropriate).
  • Support validation efforts, if required.
  • Support the implementation of EPS initiatives through
  • Creation/Revision of SOP’s (may be responsible for editing) and Work instructions (may be responsible for editing)
  • Conversion of existing batch records into EPS format
  • Walk-down of processes and BR’s and propose improvements to process flow, including
  • Ability to identify steps that should have separate sign-offs (ie. >30 minutes span), based on total process time and knowledge of the respective process trace.
  • Ability to effectively explain and communicate processes or proposed improvements, in a manner that promotes understanding by non-Manufacturing trained team members.
  • Creation of Learning Qualification Modules
  • Creation of training presentations, and management of Mfg. trainings
  • Create new SOP’s, PM’s, Batch Records or other GMP documentation, as needed.

Key Requirements

  • BS in Biotechnology, Biology, Chemistry, or equivalent. Preferred area of study:  Science related disciplines
  • Demonstrated working experience in manufacturing; GMP experience and API manufacturing experience; project management experience preferred
  • 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, planned 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. 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. 
  • Strong written and verbal communication skills
  • Demonstrate ability for effective Planning, Organizing and Controlling competency
  • 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.

Reference: R31263
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