Principal Scientist (Pathogen Safety)Tech Ops

CSL Plasma • Kankakee, IL

13d

About The Position

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

Requirements

• Bachelor’s degree in a relevant scientific or technical field (e.g., Virology/Microbiology, Biotechnology, Biology/Chemistry, etc.)
• 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
• Deep expertise in relevant technical discipline(s)
• Strong collaboration and stakeholder management skills, with the ability to influence without direct authority
• Excellent communication skills
• 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

Nice To Haves

• Advanced degree (MS or PhD) in a related field strongly preferred

Responsibilities

• Plans and executes scientific work packages including scientific risk assessments, product complaints, and technical writing.
• Resolves technical or operational issues affecting work packages deliveries committed by Pathogen Safety x-IPT.
• 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.
• Identify opportunities to improve workflows and knowledge sharing within the Pathogen Safety Support group
• Provides training of Ops staff in Pathogen Safety matters.
• Ensure scientific support activities adhere to required standards, regulatory requirements, and internal SOPs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level