CSL Plasma
Director, Primary Manufacturing
At a glance
Location: US-NY-Liverpool Map
Posted: 04/11/2021
Closing: 05/10/2021
Degree: Not Specified
Type: Full-Time
Experience: At least 7 year(s)
CSL Plasma
Job description
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 incumbent is accountable for leading, directing, and managing all aspects of the Primary Manufacturing business unit in Liverpool.  This includes achieving supply targets and optimizing manufacturing productivity and output for Primary 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 Liverpool Site.

This role has direct functional responsibility includes approximately 150 FTE staff members.

  • 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

Knowledge, Skills & Competencies

Technical Skills

  • Subject matter expert in drug substance related operations including cell culture and purification technologies

  • Understand of Engineering and Automation best practices

  • Lean Manufacturing Methodologies

Building Effective Teams:

  • Creates high impact, efficient teams across the function, including members with different but complementary skills and expertise

  • Empowers team leads and managers to work together to make decisions and accomplish goals, providing mentorship and support when needed

  • Serves as an advocate for teams across the function, prioritizing demands, ensuring organizational support and resolving issues

Developing Direct Reports and Others

  • Motivates others, including senior leaders, to take responsibility and have proactive discussions about career goals and development

  • Encourages and promotes learning opportunities for employees to develop across the function, creating a safe environment for employees to demonstrate new skills

  • Advocates for employees and managers by communicating their capabilities and accomplishments across the function

  • Provides input and suggestions to other leaders within the function regarding efficient delegation and staffing decisions

  • Contributes to long-term workload planning, ensuring that leaders within the function are informed of staffing and resource needs

  • Enables a culture of ownership and delegation by giving individual authority and responsibility to senior managers and leaders

Strategic Agility

  • Accurately anticipates future consequences and trends, assessing the internal and external environment and leveraging new sources of data 

  • Communicates the vision and goals of the function to employees in a compelling manner to gain support and motivation

Identifies criteria to assess strategic alignment and success of plans, tracking against measurable success factors

Minimum Experience Requirements

  • Minimum 10+ years’ related industry experience required

  • At least 7 years of production management experience preferred

  • 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.

  • Continuous improvement orientation.

  • Ability to lead change. 

Director, Primary Manufacturing