Compliance Scientist I - MST (Hybrid - Colorado - 32 Work Week)

Purpose and Scope

Independently develops, tests, validates and approves new test methods and procedures for chemical and instrumental methodology to ensure accuracy and consistency. Mentors less experienced analysts. The Compliance Scientist I uses in-house standard operating procedures, compendial documents, industry guidances and pharmaceutical industry knowledge to perform tasks. Fosters an environment of safety and company culture.

Essential Duties & Responsibilities:

Analytical Services

• Apply and stay current on drugs and medical devices regulations, including USP, ICH and FDA regulations for cGMP and GLP independently.
• Advise on project decisions with potential regulatory consequences.
• Knowledgeable in the execution of compendial methods, specifically USP and EP.
• Complete impact assessments for compendial updates and assist QA Development in initiation of related change controls.
• Assist the Quality Control (QC) laboratory in troubleshooting test method issues.
• Efficiently write, review, and approve technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies.
• Adhere to validated test methods, standard operating procedures, and applicable guidance.
• Use technical discretion in designing, executing, and interpreting experiments that contribute to project strategies.
• Serve as contact for vendors and contract laboratories.

• Present supplier notifications and impact assessments to MST Change Control meetings.

• Complete assessments and resulting change actions for supplier items.
• Interact closely with project teams across departments and outside testing laboratories.
• Interpret, review, and discuss data from outside testing laboratories.
• Provide analytical support to Formulation Development and interact with team members in exchanging technical expertise.
• Act as a subject matter expert (SME) in instrumentation, methodology, and guidance.
• Perform other duties as assigned.

Audits and Inspections

• Lead communications and strategy for external and internal audits, serving as primary contact for regulatory inspectors and auditors.
• Develop and implement compliance programs, proactively identifying and mitigating risks.
• Lead resolution of complex compliance issues, collaborating with regulatory agencies and internal stakeholders.
• Escalate and manage significant risks, ensuring timely and effective corrective actions
• Support self-audit efforts and developed strategies for compliance and remediation.
• Act as Training Admin-Assign and verify training for new employees and expedited documents.

Data Analytics and Trending

• Support the design and execution of Continued Process Verification (CPV) program and associated reports, including advanced statistical analysis and data modeling.
• Support the development of protocols, reports, and data visualizations using tools such as JMP and LIMS.
• Facilitate and chair Signal Escalation Board meetings, driving cross-functional decision-making and continuous improvement.
• Track and manage CAPAs, deviations, and effectiveness checks, ensuring closure and compliance.
• Support the design and execution of Analytical Method Performance Monitoring (AMPM) program and associated reports, including advanced statistical analysis and data modeling.

Mentorship and Cross-Functional Leadership

• Mentor and train MS&T team members and cross-functional partners in compliance best practices, data analysis, and regulatory expectations.
• Facilitate cross-departmental projects, fostering collaboration and knowledge sharing.
• Serve as SME for GxP, ICH, and other regulatory guidelines, providing guidance on interpretation and application.

• Participate in scientific conferences if requested.

Strategic Initiatives

• Identify and drive process improvements, leveraging Lean/Six Sigma or similar methodologies.
• Represent MS&T Compliance in organizational initiatives and external partnerships.

• Apply statistics for analytical chemistry, data trending, out of specification data, and method development and validation.
• Perform risk assessments for supplier and compendial changes.
• Serve as a project lead with little to no supervision.
• Introduce new concepts, practices, instrumentation, techniques, and methodology that can be leveraged to solve current research questions.
• Advise senior management on project technical details
• Express scientific creativity in solving current R&D challenges.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

Knowledge

• Experience with FDA regulations, USP, NF, ICH, EP, and their application in the laboratory.
• Advanced writing and accurate review of technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies.
• Demonstrated understanding of drug product formulation development.
• Demonstrated understanding of critical quality attributes (CQAs) of drug products based on formulation and stability.

Skills

• Experience with the use of electronic document management system(s).
• Extensive experience using word processing, spreadsheet, and database programs. Experienced with MS Office.
• Experience with computer systems for sample tracking and raw data handling.

• Advanced proficiency with data analytics tools and process improvement methodologies.

• Demonstrated proficiency with test method development and validation.
• Effective written and oral communication skills.

Abilities

• Learn and apply new techniques.
• Ability to present in team meetings.
• Attention to detail. Efficient, accurate, and consistent in data compilation and review.
• Work independently and with other analysts, handle multiple projects and timelines concurrently.
• Demonstrate problem-solving in a timely manner.

• Strategic thinking and problem-solving abilities, with a continuous improvement mindset.
• Strong leadership, mentoring, and cross-functional collaboration skills.
• Exceptional organizational, interpersonal, and communication skills, with the ability to influence at all levels.
• Proven ability to manage multiple complex projects, set priorities, and deliver results under tight timelines.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the wellbeing of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprisewide mindset that lifts the whole organization.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risktaking that drives better ways of working.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's or graduate degree in chemistry or related field.
• Ten or more years of related analytical laboratory experience, a minimum of six years in a pharmaceutical environment is preferred, with an emphasis on methods development and validation.

Working Conditions

• Working conditions are typical for an office environment.
• Laboratory and office setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

Compensation and Benefits

• Pay: $90,000 to $95,000, based on 32 hour work week anddepending on experience
• Bonus eligible
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.