Sr. Manager, Berinert & Beriplex Manufacturing

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Apr 04, 2021
Ref
R-131210
Required Education
Other
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

The Manufacturing Manager is responsible for managing and directing all activities required to facilitate manufacturing within a specific Value Stream for the Kankakee site.

The role will direct the activities within the specific manufacturing value stream department to assure the timely production and release of conforming therapeutic human plasma products in accordance with company policies, current rules and regulations, current GMP regulations, and business strategies. Manages the manufacturing department to continually improve safety, product quality, performance, and efficiency of manufacturing processes in compliance with regulatory agencies, safety guidelines, and budget controls. Develops personnel within the department in order to meet Value Steam, Kankakee, and CSL goals and objectives. Plans for the short and long-term manufacturing needs of the company.

Responsibilities:
  • Complies with requirements of CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
  • Responsible for managing the selection, performance, and ongoing development of people within the Value Stream team as well as developing succession, retention, and development plans for key talent.
  • Accountable for the resource allocation and operational budgets of the department aligned to the Manufacturing organization's goals and objectives.
  • Develops manufacturing strategies and implements actions aligned with short and long-term tactical plans to support the Manufacturing organization's ability to achieve agreed upon goals and objectives, whilst managing any impacts on the broader CSL Behring Kankakee business.
  • Manages and delivers cross-functional manufacturing projects to improve safety, quality, productivity, and customer satisfaction and/or reduce risk with particular focus on change controls, risk assessments, deviations, CAPAs and audits.
  • Supports future production capacity and capability expansion programs by contributing expertise and resources in specific operational service processes and disciplines.
  • Oversees the delivery of maintenance support to resolve important/critical issues significantly impacting safety, quality, production, compliance and/or cost by supporting direct Manufacturing and/or Quality.
  • Drives the use of risk-based and data driven continuous improvement to deliver improvements in safety, quality, and productivity.
  • Responsible for ensuring harmonization of the local manufacturing practices with CSL Behring global operations best practices.
  • Creates, standardizes, implements and improves manufacturing documentation including the development and co-ordination of technical training programs.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, etc.)
  • Places a high priority on developing others through coaching, feedback, and developmental goals.
  • Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.
  • Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
  • Complies with the requirements of the contract agreement between CSL and the International Chemical Worker's Union.
  • Completes any other duties/responsibilities assigned by value stream leadership.


Requirements:
  • Bachelor's degree in Life Sciences or Engineering
  • 5-7 years managerial operations experience (R&D, Tech Services, Quality or Manufacturing) in a pharmaceutical, biotechnology, or biological industry.
  • 3-5 years experience in a cGMP manufacturing facility
  • Demonstrated understanding of cGMP, regulatory requirements and relevant environmental, health and safety requirements as applicable to manufacturing.
  • Up to date knowledge of validation technology, production and management processes within and external to the pharmaceutical industry
  • A team player with demonstrated initiative and proven problem solving, communication and negotiation skills
  • Excellent communication and interpersonal skills with proven ability to establish, enhance and manage customer relationships.
  • Sound understanding of engineering, microbiology and statistical principles
  • Computer Literacy (SAP, Trackwise, Microsoft Offices, other)


Competencies:
  • Drives Results
  • Plans and Aligns
  • Manages Complexity
  • Strategic Mindset
  • Collaborates
  • Communicates Effectively
  • Builds Effective Teams
  • Ensures Accountability
  • Optimizes Work Processes