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Chemical Risk Assessment Jobs in Minnesota (NOW HIRING)

Hawkins Inc.

Safety Specialist

Roseville, MN

$110K - $130K/yr

... chemical manufacturing and distribution teams. This role applies risk assessment methodologies to proactively identify hazards and implement effective controls aligned with the Hierarchy of Controls.

Hawkins

Safety Specialist

Roseville, MN · On-site

$110K - $130K/yr

... chemical manufacturing and distribution teams. This role applies risk assessment methodologies to proactively identify hazards and implement effective controls aligned with the Hierarchy of Controls.

Koch Industries

Industrial Hygienist

Rosemount, MN · On-site

$100K - $130K/yr

Utilize applicable exposure limits (e.g., OSHA PELs, ACGIH TLVs) to assess risk and recommend appropriate controls * Manage chemical safety programs, including SDS review processes and site chemical ...

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Chemical Risk Assessment information

What is chemical risk assessment?

Chemical risk assessment is the process of evaluating the potential adverse health and environmental effects caused by exposure to chemicals. This involves identifying hazards, assessing how and where people or the environment may be exposed, determining the level of risk, and recommending ways to manage or mitigate those risks. Chemical risk assessment is crucial in regulatory decision-making, workplace safety, and environmental protection. Professionals in this field use scientific data, exposure models, and toxicological information to inform policy and safeguard public health.

What are some typical challenges faced by professionals in chemical risk assessment roles, and how can they be addressed?

Professionals in Chemical Risk Assessment often encounter challenges such as interpreting complex toxicological data, keeping up with evolving regulatory requirements, and effectively communicating risks to both technical and non-technical stakeholders. Addressing these challenges involves continuous learning, close collaboration with regulatory experts and scientists, and developing strong communication skills to present findings clearly. Working in multidisciplinary teams also helps ensure that assessments are comprehensive and aligned with organizational and legal standards.

What are the key skills and qualifications needed to thrive as a chemical risk assessor, and why are they important?

To thrive as a Chemical Risk Assessor, you need a solid background in chemistry, toxicology, and environmental science, typically supported by a relevant degree. Familiarity with risk assessment models, regulatory databases, and statistical analysis software such as EPA’s EPI Suite or OECD tools is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital for interpreting data and conveying complex findings to stakeholders. These skills are crucial to ensure the accurate evaluation of chemical hazards and compliance with safety regulations, ultimately protecting public health and the environment.

What is the difference between Chemical Risk Assessment vs Chemical Safety Specialist?

AspectChemical Risk AssessmentChemical Safety Specialist
Primary FocusEvaluating chemical hazards and risks to health and environmentImplementing safety protocols and ensuring compliance in chemical handling
Required CredentialsDegree in chemistry, toxicology, or related field; risk assessment certificationsSimilar credentials; safety certifications like OSHA or HAZWOPER
Work EnvironmentLaboratories, risk assessment teams, regulatory agenciesIndustrial sites, manufacturing plants, safety departments
Industry UsageRegulatory compliance, environmental agencies, consultingIndustrial companies, chemical plants, safety consulting

While both roles involve chemical safety, Chemical Risk Assessment focuses on analyzing hazards and determining risks, whereas Chemical Safety Specialist emphasizes implementing safety measures and ensuring compliance in workplaces.

What are popular job titles related to Chemical Risk Assessment jobs in Minnesota?

For Chemical Risk Assessment jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Chemical Risk Assessment jobs in Minnesota look for?

The top searched job categories for Chemical Risk Assessment jobs in Minnesota are:

Chemical Risk Assessment jobs near you
Infographic showing various Chemical Risk Assessment job openings in Minnesota as of August 2026, with employment types broken down into 1% As Needed, 91% Full Time, 6% Part Time, and 2% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution.

Senior Manager, Extractables & Leachables

kindeva

Woodbury, MN

Full-time

Posted 22 days ago

Kindeva rating

6.7

Company rating: 6.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

Kindeva Drug Delivery is seeking an experienced Manager, Chemical Characterization, Extractables & Leachables to lead a multidisciplinary analytical organization supporting pharmaceutical, combination product, and medical device programs. This role provides scientific, operational, and people leadership for teams responsible for chemical characterization, method development, extractables and leachables (E&L) assessments, trace-level analytical testing, and component clearance activities supporting Kindeva's inhalation, transdermal, injectable, and drug-device combination product portfolios.

The successful candidate will serve as a technical and regulatory subject matter expert in E&L and chemical characterization programs, ensuring testing strategies align with current regulatory expectations, business objectives, and product development requirements. This individual will oversee both advanced analytical development activities and routine testing operations while partnering closely with Manufacturing, Quality, Regulatory Affairs, Toxicology, Supply Chain, and Product Development teams.

The position requires recognized expertise in applying USP <1663>, USP <1664>, ISO 10993 chemical characterization requirements, PQRI recommendations for inhalation products, and toxicological risk assessment principles to develop scientifically sound and regulatory-compliant extractables and leachables strategies.

We are seeking a proven leader who can translate complex regulatory requirements into practical laboratory strategies while maintaining high scientific standards and operational excellence.

Responsibilities

Leadership & Organizational Management

  • Lead and develop a team of analytical chemists and laboratory professionals supporting chemical characterization, extractables and leachables testing, trace impurity analysis, and component clearance programs.
  • Provide coaching, mentoring, performance management, succession planning, and career development for scientific staff.
  • Establish priorities and allocate resources across multiple commercial, development, and compliance-driven programs.
  • Foster a culture of scientific excellence, collaboration, accountability, and continuous improvement.
  • Develop departmental goals, metrics, and capacity plans aligned with organizational objectives.

Scientific & Technical Leadership

  • Provide technical oversight for extractables and leachables programs supporting inhalation products, transdermal systems, injectables, medical devices, packaging systems, and drug-device combination products.
  • Designing technical approach for testing and instrumentation and presenting to clients, assisting in building of quotes and helping manage projects as the E&L Leader.
  • Lead development, qualification, validation, transfer, and lifecycle management of analytical methods.
  • Oversee chemical characterization studies utilizing techniques such as:
    • GC-MS
    • GC-MS/MS
    • LC-MS
    • LC-MS/MS
    • High-resolution mass spectrometry (HRMS)
    • ICP-MS
    • Chromatographic and spectroscopic techniques
  • Guide investigations involving unknown compound identification, contamination events, atypical results, and complex analytical challenges.
  • Support structural elucidation and non-targeted analytical evaluations.
  • Drive implementation of new analytical technologies and laboratory capabilities.

Component Clearance & Quality Operations

  • Lead analytical programs responsible for qualification and clearance of plastic, elastomeric, and other critical components used in drug delivery systems.
  • Partner with global manufacturing sites to ensure efficient testing, qualification, and release of critical materials throughout the supply chain.
  • Ensure timely execution of routine and complex analytical testing to support development and commercial manufacturing requirements.
  • Provide technical oversight for reference standards management and related analytical support activities.
  • Drive improvements in laboratory efficiency, throughput, and service levels.

Regulatory & Compliance Leadership

  • Serve as a subject matter expert in global regulatory expectations for extractables, leachables, and chemical characterization programs.
  • Maintain expertise in:
    • USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
    • USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
    • ISO 10993-18 Chemical Characterization of Medical Device Materials
    • ISO 10993-17 Toxicological Risk Assessment of Medical Device Constituents
    • ISO 10993-12 Sample Preparation and Extraction Methods
    • PQRI recommendations for orally inhaled and nasal drug products (OINDP)
    • Nitrosamine guidance and emerging contaminant requirements
    • Applicable FDA, EMA, USP, EP, and international regulatory expectations
  • Partner with Toxicology and Regulatory Affairs teams to establish:
    • Analytical Evaluation Thresholds (AET)
    • Reporting thresholds
    • Identification thresholds
    • Qualification thresholds
    • Toxicological risk assessments
  • Support product submissions, technical justifications, regulatory inspections, and customer audits.
  • Help define analytical and regulatory strategies for inhalation combination products, container closure systems, and medical devices.

Cross-Functional Collaboration

  • Collaborate effectively with Manufacturing, Product Development, Quality Assurance, Regulatory Affairs, Toxicology, Supply Chain, Procurement, Project Management, and Commercial teams.
  • Serve as a technical interface with customers, suppliers, external laboratories, auditors, and regulatory agencies.
  • Communicate complex scientific information clearly to both technical and executive audiences.
  • Support strategic decision-making through strong scientific and risk-based assessments.

Continuous Improvement

  • Drive operational excellence initiatives focused on laboratory efficiency, capacity, quality, and cost effectiveness.
  • Implement continuous improvement programs utilizing Lean, Six Sigma, or other improvement methodologies.
  • Identify opportunities to streamline testing processes and accelerate component clearance timelines.
  • Monitor industry trends and emerging regulatory expectations to ensure proactive capability development.

Qualifications

  • Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline.
  • Minimum 10 years of analytical chemistry experience within pharmaceutical, medical device, combination product, or regulated healthcare industries.
  • Minimum 5 years of leadership experience managing scientific or laboratory teams.
  • Demonstrated expertise in extractables and leachables, chemical characterization, trace-level analytical testing, impurity analysis, or related disciplines.
  • Extensive experience with chromatographic and mass spectrometry techniques including GC-MS and LC-MS platforms.
  • Strong understanding of cGMP laboratory operations and quality systems.
  • Experience supporting regulated product development, commercial manufacturing, and supply chain activities.
  • Proven experience working within cross-functional organizations.
  • Strong technical writing, data interpretation, and communication skills.
  • Strong statistical knowledge, data trending capabilities, and experience establishing analytical specifications.

Preferred Qualifications

  • Master's degree or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Toxicology, or related scientific discipline.
  • Direct experience leading extractables and leachables programs for pharmaceutical packaging, inhalation products, medical devices, or combination products.
  • Experience with inhalation, transdermal, injectable, and drug-device combination products.
  • Expertise in PQRI-based E&L programs and inhalation regulatory strategies.
  • Familiarity with toxicological risk assessment methodologies and interpretation of E&L data.
  • Experience supporting regulatory submissions and direct interactions with health authorities.
  • High-resolution mass spectrometry and unknown identification expertise.
  • Lean, Six Sigma Black Belt, or equivalent continuous improvement certification.

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