Sr. Manager, Quality Control (Biochemistry & Immunology)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Nov 20, 2020
Ref
R-125606
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 Senior Manager provides oversight of two independent laboratories which are responsible for strategic and technical expertise for the US FCC HS facility. This individual is the Immunology subject matter expert for global supply of vaccines in collaboration with the Technical Development group. The Senior Manager of Immunology is responsible to define and implement the strategy to utilize a lean organization which can successfully release high volumes of samples generated in the development organization or commercial organization over very condensed periods of time throughout the entire manufacturing process. The role represents the QC department on the site Biosafety committee . This individual is accountable for managing communication with both internal and external regulatory collaborating centers.

Major Responsibilities:
  • Serves as the QC Immunology single point of contact for Holly Springs, supporting local product testing, validation/qualification activities; assay development/improvement activities, technical transfers and routine testing at CMOs.
  • Ensures that team performance as well as test methods, qualification, validation, and technical protocols, GLIMs builds and reports comply with site SOPs.
  • Provides QC oversight to equipment qualification and validation in areas owned by Senior manager
  • Primary QC reviewer for regulatory filings for area
  • Collaborates with AS&T for assays under development to ensure staffing and support are adequate for execution of studies
  • Collaborates with MS&T to complete performance monitoring/new strain verification studies
  • Collaborates with Manufacturing, Batch Disposition and Regulatory to ensure timely completion of Annual Strain Update and batch release activities for Holly Springs and Liverpool products filled here
  • Serves as Accountable person for two laboratories, Biochemistry and Virology in Holly Springs.
  • Biochemistry: responsible for Drug Product and Raw material release testing
  • Virology: responsible for Virus seed testing, working cell banks, drug substance and drug product testing.
  • Accountable to ensure development of all levels of organization, as well as overseeing the strategy of the organization in alignment with Seqirus' 10 year plan.
  • Ensures teams operate to budget and efficiently sustains testing capacity to meet site production plan while maintaining the highest degree of compliance
  • Operates as the site liaison with regulators (CBER, PEI, TGA or ISS) for QC testing matters. Represents Seqirus through direct contact with the regulatory release agencies. Is responsible to write and review regulatory filings to support TD, AST and QC.
  • Builds, manages and develops high performing cross-functional teams by clearly defining expectations, holding individuals accountable, recognizing accomplishments
  • Ensures effective professional development of direct reports, through combination of coaching, mentoring and effective development planning
  • Complies with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and environment, health and safety (EHS) policies.
  • Ensures collaboration of own department with other functions and departments to achieve business and site objectives
  • Maintains in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to cGMP Quality Assurance activities.


Minimum Qualifications:

  • Bachelor's degree in Science / Engineering discipline required. Advanced degree preferred.
  • 7+ years industry experience with advanced knowledge of Biochemistry / Cellular Virology required, Vaccines knowledge preferred
  • Demonstrated experience and good working knowledge of method development, method validation, troubleshooting and analytical method transfer.
  • Demonstrated leadership experience in Quality Control and/or in a GMP regulated environment within the pharmaceutical industry.
  • Sterile product manufacturing knowledge and/or Biopharmaceutical experience required.
  • Strong leadership and communication skills with special emphasis on collaboration skills and experience within matrix / multi-disciplined team environment preferred
  • Very good prioritization, organizational, communication, and negotiating skills
  • Ability to motivate, develop, and inspire team members and direct reports.
  • Demonstrated knowledge of global regulatory frame-works.
  • Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally.