Director, Bulk Manufacturing

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 12, 2020
Ref
R-121697
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:

The incumbent is accountable for leading, directing, and managing all aspects of the Bulk Cell Culture Manufacturing business unit in Holly Springs, NC. This includes achieving supply targets and optimizing manufacturing productivity and output for Bulk Manufacturing. Management duties include directing aspects of personnel, facility, process, and equipment for a large scale manufacturing facility. This individual will serve as the leader coordinating the department for both process development and commercial material production. This individual will assume full responsibility as the department representative on key development projects. This leader will also sit on the site leadership team and will be responsible for playing a key role in the overall leadership of the Holly Springs Site. This role has direct functional responsibility includes approximately 150 FTE staff members.

Major Accountabilities:
  • Directs multiple teams of manufacturing staff to ensure manufacturing in accordance with schedule / customer requirements within the agreed financial constraints and according to the relevant.
  • Accountable to achieve supply targets.
  • Ensures compliance in accordance to Seqirus's quality, compliance, safety, GMP, and regulatory standards at all times
  • Sets department policy regarding staffing, hours and job junction to meet planned projects and production goals.
  • Responsible for ensuring the GMP requirements for facility and documentation for commercial material production. Works with QA/Compliance group for GMP certification of the facility and equipment. Writes and reviews GMP documents like Standard Operating Procedures and Batch Process Records. Works with the QA Raw Materials group in specifying the GMP materials needed for commercial material production
  • Responsible for ensuring that all staff are properly trained in their duties
  • Devises solutions for problems of complex scope which affect multiple areas within manufacturing. Develops operational processes and production protocols. Oversees the design, execution, and analysis or results from experiments to ascertain that high-quality data is generated. Plays a key role in troubleshooting problems in manufacturing operations
  • Assumes full responsibility as the department representative on capital projects. Makes conceptual contributions to project strategies and achievements. Directs manufacturing staff in the execution of capital projects


Minimum Requirements:
  • Bachelor's degree in chemical/mechanical/systems engineering, microbiology or cell engineering or equivalent is required. Advanced degree preferred.
  • Minimum 10+ years' related industry experience required
  • At least 7 years of production management experience preferred
  • Subject matter expert in drug substance related operations including cell culture and purification technologies
  • Understand of Engineering and Automation best practices
  • Lean Manufacturing Methodologies and continuous improvement orientation.
  • 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.