Sr. Manager, Manufacturing Sciences & Technology (Process Sciences)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Feb 03, 2021
Ref
R-129641
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 Purpose

Senior Manager of the Process Sciences Technical Team at the Seqirus Holly Springs Facility, NC. This position is responsible for leading a team of Engineers and Scientists accountable for supporting the Commercial Virus Seed selection process as well as Bulk and Fill-Finish operational business units in Holly Springs, NC. This includes leading a team responsible for review of analytical and process related data to identify improvements, support technical investigations, process development and regulatory filings. This individual will provide strategic technical direction and support for the manufacturing organizations to achieve supply targets and maximize capacity with a focus on continuous improvement.

Team serves as liaison between site operational teams like Engineering and Technical Development and internally with MS&T function working with Technical Services team and Viral Pilot Plant team.

Seqirus operates in a global network. The holder of the position will interact closely with the MS&T organisations at the other Seqirus production sites to establish and maintain a common shared vision, scientific direction, workflows and work practices. An important aspect of the job is to ensure that knowledge and learnings are shared across Sites.

Major Responsibilities:
  • Responsible for strategically establishing and maintaining a team of process scientists, providing technical and development guidance to the team. Develops and Drives team performance, lowers attrition rates and sets clear direction & priorities.
  • Supports external partners: provide technical guidance to: Regulatory for new market introductions or Regulatory questions, Clinical and Medical teams for customer technical questions, Site strain selection, Global MS&T network
  • Responsible for leading, coordinating, and aligning critical level investigations for the Holly Springs facility as well as ensuring support from the team for Product Quality Impact Assessments for investigations. Providing appropriate communication and escalation.
  • Support or lead initiatives related to process improvements, liaising with Manufacturing, QA, C&Q, Engineering, QC/AS&T and TD. Individual will need to utilize or implement appropriate KPI's and process trends in alignment with CPV Program Manager to ensure data driven improvements are identified and implemented. Responsible to present outcomes to senior leadership at and above site.
  • Partner with MS&T teams to ensure manufacturing is in conformity with up-to-date, registered, filed manufacturing processes, approved instructions and relevant cGMP and Health Authority regulations.
  • Subject matter expert for internal and external inspections and audits.


Minimum Qualifications :
  • Bachelor's degree in chemical/mechanical/systems engineering, Virology, Biochemistry, or Cell engineering or equivalent is required.
  • Master's degree or PhD preferred.
  • 7+ years' experience
  • 5+ years managerial experience in a pharmaceutical, biotechnology or biological industry preferred
  • Demonstrated knowledge of GMPs and FDA requirements
  • Strong demonstrated team leadership skills
  • Strong strategic thinking stills
  • Strong communication and collaboration skills