Principal Scientist, Tech Ops
The Pathogen Safety Support Principal Scientist, Tech Ops provides operational support for any pathogen safety matters to Kankakee site and broader Operations organization and may be required to provide scientific and technical contributions to projects across the project lifecycle and to fulfil regulatory and compliance obligations pertaining to pathogen safety.
RESPONSIBILITIES AND ACCOUNTABILITIES
- Delivery – plans and executes scientific work packages. Work packages include but not limited – scientific risk assessments for changes and deviations, product complaints, pharmacovigilance investigations, AACCS, technical writing, inspection and audit support, fulfilment of regulatory requests and commitments, annual reports and updates, epidemiological surveillance and as required technical project support to Pathogen Safety x-IPT SPOCs. Resolves technical or operational issues affecting work packages deliveries committed by Pathogen Safety x-IPT.
- Cross-IPT Collaboration – member of tier 1 Pathogen Safety x-IPT for Support resources planning. Interacts with MS&T team(s) to assess requests coming from KKE site. May be required to participate in tier 1 Pathogen Safety x-IPT meetings led by SPOCs and to support projects under Tech Ops governance.
- Continuous Improvement – Identify opportunities to improve workflows and knowledge sharing within the Pathogen Safety Support group; champion adoption of best practices and digital tools.
- Training - Provides training of Ops staff in Pathogen Safety matters.
- Compliance and Standards – Ensure scientific support activities adhere to required standards, regulatory requirements, and internal SOPs, embedding a culture of quality and compliance.
Reports To: Pathogen Safety Support Lead
Required Experience
Education
- Bachelor’s degree in a relevant scientific or technical field (e.g., Virology/Microbiology, Biotechnology, Biology/Chemistry, etc.)
- Advanced degree (MS or PhD) in a related field strongly preferred
Experience
- 5+ years of professional experience in the biopharma, biotech, or life sciences industry with significant exposure to drug development and/or commercial manufacturing environments
- Proven track record of delivering technical contributions to cross-functional projects in a pharmaceutical setting
- Experience working in cross-functional, multicultural and international teams
Competencies (Measurable or observable skills, abilities, and behaviours critical to successful job performance.)
- Deep expertise in relevant technical discipline(s)
- Strong collaboration and stakeholder management skills, with the ability to influence without direct authority
- Excellent communication skills
Working Conditions
(Physical & mental requirements.)
- Ability to manage multiple priorities in a matrixed, fast-paced environment
- Can operate in a fast-paced, matrixed environment, bringing clarity and executional rigor amid ambiguity and competing priorities
Travel Requirements (Domestic, International, frequency)
- May require travel to manufacturing and development sites (frequency and exact locations to be further defined)
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
