Downstream Manufacturing Associate, Level III Drug Substance Manufacturing

United States, Lexington (Massachusetts)

The Manufacturing Associate, Level III, will help to provide a safe, controlled work environment in all areas of expertise. Be aware of the site safety objectives and make sure they are communicated and understood. Manufacturing Associate, Level III, will be proficient in an assigned area (i.e. Downstream Processing including AKTA-based Chromatography and associated product pool filtration via single-use-technology, UF/DF, and Drug Product Filling, etc.) and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.). 

Work with customer SMEs to transfer in and maintain customers' processes in production facility.  Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. 

Collaborate with CT Manufacturing Leadership team to incorporate process and operational improvements into new customer processes in manufacturing. 

Collaborate with CT Manufacturing Leadership team to determine equipment and materials the suite will need to purchase in order to run the process. 

May act as a lead role in the absence of the Senior Manufacturing Associate. Potentially lead small teams focused on the tech transfer of customers in to Lonza CT.  Develop, schedule and deliver quality programs essential to operational readiness.

Job Description*

(Key Accountabilities)

Define all key accountabilities (5-10), which the role will be expected to perform in short to medium future. Make sure that you list the accountability on top, which the role will be doing most frequently and which has most impact on the the team/BU/Lonza. Begin each sentence with an action word, e.g. Provides appropriate coaching and performance feedback to all direct reports.

Support the definition and execution of Operational Readiness Activity for the Cell Therapy projects at LPO to include:

  • Set up of manufacturing procedures & collaboration with QA to support CT quality systems aligned with existing operations.
  • Support building & establishing the manufacturing team by participating in the interview, onboarding and training of new colleagues.
  • Support the delivery of clinical & commercial material as required.
  • Support the development, scheduling and execution of appropriate Safety, Training, Gowning, Material Movement, Visual Inspection, APS, Cleaning, Scheduling, and EM strategies.
  • Support the definition and execution of all activity in compliance with EHS requirements.

Contribute to the definition and execution of Technical Transfer activities for the CT projects at LPO/LWI to include:

  • Development of material requirements, process execution & methods transfer.
  • Developing, defining & executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.
  • Enable timely delivery of milestones for the Technical Transfer.
  • Author, review, and approve documentation (batch records, SOPs, WIs, and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.
  • Responsible for interface with customer to coordinate onsite training.
  • Organize and effectively communicate project goals, tasks and milestones of tech transfer project team to CT Management.

As project contributor collaborate with CT Manufacturing Leadership Team to ensure.

  • Timely tracking of relevant project metrics
  • Progression of necessary purchase requisitions/orders and tracking through delivery
  • Appropriate interaction with assigned external (customer) and internal stakeholders.

Key requirements:

  • High School Diploma or Equivalent minimum; AS/BS preferred

  • Preferred area of study:  Science related discipline

  • Intermediate to Advanced level of experience in a manufacturing setting preferred

  • Proven logic and decision making abilities, critical thinking skills

  • Strong written and verbal communication skills are required

  • The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities.  Is open to and actively seeks out feedback on their performance and translates that feedback into action.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement themselves.  At Lonza, we respect and protect our people and our environment.  Any success we achieve is no success at all if not achieved ethically.

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: R41070