Quality Control Scientist I - NMR

Purpose and Scope

The Quality Control Scientist I - NMR is a technical leader within the QC functional area with a primary role in scientific development, testing, and mentoring of junior analysts. The role is intended for a person with significant pharmaceutical laboratory experience who will contribute product-specific scientific knowledge and analytical skills to the QC group.

Essential Duties & Responsibilities

• Assume a high level, in-depth scientific leadership and mentoring role in the QC laboratory for junior analysts and peers.
• Conduct complex and challenging QC testing using a variety of instrumentation that requires a high level of analytical technical expertise and in-depth knowledge in chemistry.
• Act as a primary technical resource for and be a point of contact for QC and external departments.
• Resolve testing issues including Out of Specifications and investigations for commercial, stability, and developmental samples.
• Provide scientific recommendations and technical expertise for new instrumentation and methodology.
• Support laboratory management in test assignments based on commercial and stability timelines and provide hands-on testing support during commercial exigencies.
• Assist the departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Execute all business and department goals and initiatives on time.
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Identify and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Participate on project teams, company and department meetings, third party audits, and regulatory audits.
• Demonstrate leadership aptitude in technical functions.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Respond to spills per CP 030-0202 Chemical Spill Response.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Expert knowledge of NMR instrumentation and data analysis.
• Demonstrated knowledge of fundamental chemistry pertaining to specific products and assays conducted in the Tolmar QC laboratory.
• A strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively.
• Expert knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Knowledge of cGMP practices, regulatory and ICH guidelines.
• An excellent grasp on USP and other compendial methods.
• Knowledge of computer applications including Microsoft Office.
• Experience in authoring technical reports.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.
• Ability to manage multiple projects concurrently and under tight time constraints.

Core Values

• Center on People: Support the well-being of patients and treat employees and those served as valued partners.
• Proactive & Agile: Embody a culture of engagement and action with a hands-on approach to adapt to change.
• Act Ethically: Conduct business in an ethical, compliant, and socially aware manner, cultivating diversity, equity, inclusion, and sustainability.
• Constantly Improve: Enhance products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality.
• Are Accountable: Think, act, and communicate honestly, transparently, and clearly in alignment with core values, taking responsibility and ownership of work, actions, successes, and setbacks.

Education & Experience

• Previous in-depth NMR testing and troubleshooting experience is required.
• BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Experience in the pharmaceutical industry to include experience with cGMP analytical testing of drug substances (DS) and Drug products (DP), preferably in high-volume Quality Control laboratory required.

Working Conditions

• Typical office and laboratory settings, including exposure to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours.

Compensation And Benefits

• Annual pay range: $115,000 - $125,000 depending on experience.
• Bonus Eligible.
• Benefits information available at: https://www.tolmar.com/careers/employee-benefits.

Tolmar is an Equal Opportunity Employer

• We do not discriminate on the basis of 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.