Laboratory Supervisor

Employer
CSL Behring
Location
Union, South Carolina
Posted
Nov 11, 2020
Ref
R-124572
Discipline
Science/R&D, Laboratory
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

  • Responsible for supervising the Chemistry Laboratory testing functions and ensuring that all lab practices and procedures comply with the current GMP's, GLP's, safety requirements and other applicable standards. Performs analytical activities employing traditional analytical methods and start of the art instrumentation.
  • RESPONSIBILITIES
  • Supervises and trains the chemistry analyst staff to ensure chemistry testing services are executed efficiently and in compliance with procedures and industry regulations.
  • Responsible for the plant stability program. Manages stability test protocols, scheduling of testing, performs associated analytical testing and completes stability test reports.
  • Evaluates current analytical test methods for improvement opportunities. Develops new test methods for compliance with updates to regulations, standards and changes in equipment.
  • Reviews, revises and maintains chemistry testing procedures for accuracy, adequacy and compliance to regulations.
  • Investigates out of limit results, determines root cause(s) and drives corrective actions.
  • Identifies needs for analytical instrumentation and assists with procurement and training.
  • Supports the product improvements and changes through the development of testing strategies and methods.
  • Conducts standardized tests using a variety of wet chemistry and instrument test methods.
  • Accountable to manage corrective actions and lead projects related to chemistry analytical testing.
  • Responsible for interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems or other job-related duties as assigned.


Education
  • Bachelor's Degree in Science with Biology/Microbiology or Chemistry major is required

Experience
  • Minimum five (5) years' experience with lab equipment and method validation
  • Minimum one (1) year experience with laboratory supervision is required

Additional Comments
  • Familiarity with Quality Systems (e.g., ISO, FDA regulations) Lean Manufacturing, Manufacturing Process Control, Six Sigma is required
  • Knowledge of GMP's, QSR, USP and ICH regulations and standards is required


Working Conditions

(physical & mental requirements)
  • Excellent collaboration and team building skills
  • Effective leadership and interpersonal skills and ability to articulate and responsive to colleagues
  • Strong verbal, written communication and listening skills
  • Demonstrated problem solving
  • Ability to represent the company with external constituents
  • Ability to lead and manger others
  • Demonstrated analytical skills
  • Strong understanding of quality practices applicable to the manufacture of medical filters including customer and industry standards
  • Understanding and interpretation of test data, scientific work-knowledge in product failure analysis
  • Possess knowledge on Statistical Process Control (SPC)
  • Excellent knowledge in validation
  • Fast paced environment with frequent interruptions


Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.