Sr. Manager, Site Analytical Science and Technology

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Aug 29, 2020
Ref
R-120640
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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

Job Summary:

Reporting to the Global Head of Analytical Science and Technology at Seqirus the role provides leadership for the QC Site AST organisation. This role is responsible to establish and manage QC method technology improvements aligned to the company strategy. This individual will ensure implementation of method validation, qualification, lifecycle management, inter site method transfers and method replacement/refinement. The individual will manage and maintain a functional testing laboratory in support of technical development / MS+T pilot plant manufacturing processes required in support of critical manufacturing process parameter activities and new strain introduction. Ensuring that all relevant company systems and policies are adhered to and that appropriate standards of GMP, EHS and housekeeping are applied. ( Liverpool Only ). This individual will deliver efficiency in QC through method standardization and implementation of new QC testing technologies. The role provides technical support and expertise to the QC function. This individual will lead ATS resources at the site and collaborate with the global AST team implementing alignment of AST processes and delivery of the QC function strategic plan.

Major Responsibilities:
  • Manage day to day activities of the Holly Springs Analytical Science and Technology group. Activities include method validation and transfer, QC test optimization and modernization, and support of deviation investigations.
  • Implement the Global QC test modernisation/replacement strategy for Site AST. Enable collaboration between AST and TD to deliver against the strategic plan to attain industry leadership in laboratory operations.
  • Delivers the Global QC tech transfer plan aligned to business requirements to ensure optimization of QC operations and sustain compliance status of QC testing
  • Implement and sustain QC method variability reduction program through invalid trending, control trending and method standardization to maximize the reliability of QC data used by our manufacturing teams.
  • Implement and sustain a fit for purpose method validation lifecycle for QC to maintain compliance with regulatory body requirements and expectations.
  • QC pharmacopeia reviews, regulatory surveillance and specification management.
  • Manage and Maintain (GMP) laboratory testing facility to support testing requirements in support of critical manufacturing process parameters and new strain introduction Pilot Plant activities in support of the site manufacturing strategy.
  • Provide leadership and guidance to Site AST.
  • Set objectives and provide clear direction for execution.
  • Responsible for organizational design and staffing decisions.
  • Recruit, retain, train and develop Site AST team.
  • Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.

Minimum Requirements:

  • Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.); advanced degree preferred
  • Minimum 7+ years' experience in microbiological and biological, chemical or biochemical analytics in a pharmaceutical/medicinal GMP environment; 10+ years' experience preferred in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
  • 5+ years of managerial experience preferred
  • Experience working in a highly regulated GMP environment as it applies to laboratory functions
  • Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up.
  • Experience with QC testing methods and processes
  • Experience with assay methodologies and validation techniques.
  • Experience with implementing root cause analysis and effective investigation practices.
  • LEAN experience, preferred