Sr. Manager, Manufacturing (Bulk)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jan 09, 2021
Ref
R-127021
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

Job Summary:

The incumbent will be a Senior Manager, Manufacturing in one of the areas of the Bulk Flu Vaccine manufacturing. The role will ensure the timely production of quality drug substance in a safe, cost-efficient and environmentally responsible manner.

Major Responsibilities:
  • Provide direct management of a commercial Bulk Drug Substance operation (Support, Cell Expansion, Purification).
  • Manages production teams through supervisor direct reports to ensure safety, training and quality compliance are prioritized for manufacturing goals.
  • Prepares and monitors capital and expense budgets. Establishes standards and manpower requirements to meet production and budget targets.
  • Establishes the manufacturing plan and ensures resources are managed to deliver. Accountable for overall metrics and performance of team.
  • Successfully engages across the organization with peers and direct reports to set goals, budgets, objectives, and monitor performance to assure continuous improvement.
  • Accountable for the timely completion of investigations that prevent reoccurrence
  • Drives continuous improvement initiatives and implementation of Operational Excellence
  • Leverages process and compliance expertise to facilitate cross functional decision making and strategy alignment

Minimum Qualifications:

  • Bachelor's degree in Engineering or Science discipline or its equivalent is required.
  • 7+ years' relevant industry manufacturing experience required; 10+ years' experience strongly preferred
  • At least 3+ years of management experience in pharma/biotech/biologics manufacturing industry is required. 7+ years preferred in production/manufacturing management.
  • Strong knowledge of Regulatory Requirements and Experience interfacing with Regulatory agencies during external inspections and during regulatory response writing.
  • Demonstrated knowledge of GMPs and FDA requirements
  • Strong demonstrated team leadership skills
  • Strong project management skills preferred
  • Manufacturing Financial Knowledge understanding of manufacturing financial accounting (budgeting, bills of materials, variances, recoveries, depreciation, working capital, etc.) and analytical skills to identify problems and opportunities.
  • Continue improvement orientation/ Ability to successfully lead change