QC Technical Specialist – Cell Growth Assay/New Product Introduction

United States, Walkersville (Maryland)

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.

Lonza Walkersville, MD has an exciting opportunity for a QC Technical Specialist – Cell Growth Assay / New Product Introduction. This successful

candidate will lead projects and be responsible for performance of Quality Control Cell based assays.  Areas of focus are cell based release tests, technical transfer, and assay validation, technical liaison for contract manufacturing activities, project assessment, and implementation. This individual will be responsible for ensuring that cell based assays progress according to customer contract and quality standards, SOP’s, ICH, cGMP, ISO, and/or other guidelines to full fill regulations.

Primary Role Responsibilities:

  • Leads projects associated with technical transfer designated for Cell based Assays.
  • Collaborates closely with QC Management, Quality Control Technology Transfer Specialist, Process Development, and Project Management teams to drive assay validation, technical transfer and staff training.
  • Oversees quality control cell based testing, laboratory records and other documentation for accuracy, appropriateness and timeliness.
  • Develops knowledge of base of staff, Project Managers and other key stakeholders. Conducts project team meetings to plan and review completion of assignments.
  • Ensures corporate cGMP and GLP compliance of all activities performed.
  • Reviews and approves Standard Operating procedures: assists with responses to audits, deviations, out of specifications, customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPAs), preventative maintenance, and calibrations.
  • Perform other duties as assigned

Skill and/or Education Requirements:

  • B.S. Degree in a relevant area (biology/bio-engineering related) is required. Experience in the life science industry is required.
  • Cell biology and basic biochemistry; experience with a variety of cell culture systems (adherent and suspension is required).
  • Demonstrated knowledge in biological cell based assays such as proliferation, ELISA, cell growth promotion, cell staining and immunofluorescence microscopy.
  • Aseptic technique / work with BSC level 2 is required.
  • Mammalian cell culture experience.
  • Experience with Cell culture media is preferred.
  • Able to write complex procedures and reports and proficient in the use of spreadsheets, databases and word processing software. Performs statistical analysis of data.
  • Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
  • Demonstrated experience in initiating and leading teams and projects.
  • Knowledge of CFRs, cGMP’s, GLPs and biotechnology processing. Ability to interpret and apply GMP and regulatory knowledge in routine and non-routine cases.
  • Stem cells culture (MSC, PSC, HESC) techniques and media requirements experience desired
  • Closed cell culture and downstream processing systems experience desired
  • Excellent oral/written/presentation communication skills; strong work ethic; delegating skills; ability to perform in a team setting.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements 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: R39741