Hybrid Senior Microbiologist: Sterilization & Quality Lead

Actalent; United States; Hybrid; USD 69,000 - 83,000; Part time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

PTO

Job summary

Actalent is hiring a Senior Microbiologist to lead sterilization and microbiology strategies across regulated manufacturing. You will partner with Manufacturing, Quality, Regulatory, and R&D to evaluate risks, support investigations, and ensure GMP compliance for products and contract manufacturers.

The role emphasizes scientific leadership, risk-based decisions, and cross-site collaboration, with a hybrid schedule in Arden Hills, MN and nearby sites. Travel may be required to support projects.

Qualifications

• Demonstrated experience performing scientific evaluations and technical risk assessments, particularly in microbiology and sterilization contexts.
• Strong technical writing and documentation skills, including the ability to author and review scientific reports, regulatory documentation, and risk assessments.
• Proven ability to independently manage multiple projects and priorities in a dynamic environment.
• Strong communication skills with the ability to convey complex microbiological and sterilization concepts to diverse stakeholders.

Responsibilities

• Manage assigned Sterilization Department projects, ensuring effective planning, execution, and documentation in support of product quality and regulatory compliance.
• Review regulatory documentation for design dossier submissions and Pre-Market Approval submissions, ensuring sterilization strategies and microbiological controls are appropriately justified and clearly presented.
• Develop and author sterilization-related responses to questions posed by regulatory bodies and notified organizations, providing clear scientific rationale and risk-based explanations.
• Set direction for activities that minimize regulatory exposure related to product sterilization during development and manufacturing, and actively participate in regulatory groups to ensure sterilization requirements are accurately conveyed.
• Consolidate and analyze questions received from regulatory agents across manufacturing sites, and translate these into corporate guidance that informs the writing of design dossiers and pre-market approvals.
• Act as a corporate resource for sterilization services, reviewing sterilization process validation and product qualification documentation for multiple divisions and ensuring consistency with internal standards and global regulations.
• Research, review, and interpret sterilization studies and objectives associated with new equipment development, providing recommendations to optimize microbiological safety and process robustness.
• Work directly with notified bodies to convey sterilization strategies, including delivering training, setting priorities, and resolving day-to-day issues related to sterilization and microbiological controls.
• Participate in the development and writing of international standards for sterilization technologies, contributing subject matter expertise to influence industry best practices.
• Consult on sterilization and quality issues, support problem solving and resolution, and provide guidance to internal and external customers for sterilization testing and microbiological evaluation needs.
• Serve as a microbiology subject matter expert supporting contract manufactured devices and external manufacturing partners, ensuring appropriate microbiological controls and sterilization validation.
• Support acquisition due diligence activities by assessing microbiological and sterilization risks, and contribute to product integration and manufacturing transfer initiatives.
• Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes, and document risk-based conclusions and recommendations.
• Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation that underpin product claims and regulatory submissions.
• Evaluate the microbiological impact of product, process, material, supplier, and facility changes, and recommend appropriate controls, validations, and mitigations.
• Support investigations, nonconformances, corrective and preventive actions (CAPAs), and other quality system activities that require microbiology expertise, ensuring thorough root cause analysis and effective remediation.
• Partner with cross-functional teams to assess microbiological considerations related to manufacturing operations, design changes, commercialization activities, and supplier controls.
• Provide microbiology support for new product development projects and product lifecycle management activities, ensuring sterilization and contamination control requirements are integrated from concept through commercialization.
• Participate in audits, inspections, and regulatory readiness activities, representing microbiology and sterilization functions and supporting responses to regulatory and customer inquiries.
• Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements, driving standardization and robustness across sites and regions.
• Communicate microbiological risks, recommendations, and technical rationale clearly to stakeholders across multiple functions and geographic regions, influencing decisions through sound scientific reasoning.
• Independently manage multiple projects and priorities, ensuring timely completion of deliverables and effective coordination with global and cross-functional project teams.

Skills

Scientific evaluations

Technical risk assessments

Regulatory documentation

Technical writing

Stakeholder communication

Education

BS with 9-13 yrs experience

MS with 7-11 yrs experience

PhD with 4-8 yrs experience

Job description

Actalent is hiring a Senior Microbiologist to lead sterilization and microbiology strategies across regulated manufacturing. You will partner with Manufacturing, Quality, Regulatory, and R&D to evaluate risks, support investigations, and ensure GMP compliance for products and contract manufacturers.

The role emphasizes scientific leadership, risk-based decisions, and cross-site collaboration, with a hybrid schedule in Arden Hills, MN and nearby sites. Travel may be required to support projects.