Senior Manufacturing Associate II, Upstream Drug Substance

United States, Lexington (Massachusetts)

The Senior Manufacturing Associate II is the most senior level manufacturing associate position.  This position is intended for an individual that has obtained an in-depth understanding of a GMP, biotech, or similar environment, has demonstrated attributes that establishes them as a subject matter expert and/or leader in the manufacturing suites.

The Senior Manufacturing Associate II 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. Senior Manufacturing Associate II will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations.  The Senior Manufacturing Associate II will assume the lead role during manufacturing operations with primary responsibility in large scale cell culture including seed and single-use perfusion bioreactors and associated harvest/clarification operations.  Additional areas of responsibility based on production schedule demands include: seed train/cell expansion operations,  chromatography and UF/DF, vial filling, visual inspection, operations, etc. 

Key responsibilities:

  • Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.

  • Train other personnel on equipment operation, cGMPs, documentation, technical theory, or other tasks. Maintain individual training plan.

  • Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.

  • Administrative tasks – leading shift exchange, meetings, sending/receiving emails, participating in projects.

  • Perform other duties as assigned. 

Key requirements:

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

  • Preferred area of study:  Science related discipline

  • Strong experience in manufacturing; GMP setting preferred, and/or 24 months’ experience as an Associate Level III/Sr Associate in bio-pharm industry.

  • Proven logic and decision making abilities, critical thinking skills.

  • Quality Responsibility Adherence to cGMPs is required at all times during the manufacture of Active Pharmaceutical Ingredients (APIs).  All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions

  • Must have the ability to comprehend process flow and identify factors which influence the process.

  • Be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools.

  • Strong written and verbal communication skills are required.

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: R41077