Core Hours: Monday - Friday 8:00am - 5:00pm
Purpose and ScopeThe 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. Such a role may entail training and mentoring of new hires, dissemination of product specific knowledge to the QC group and technical leadership in specific projects as assigned.
- Conduct complex and challenging QC testing using a variety of instrumentation that needs a high level of analytical technical expertise and in-depth knowledge in chemistry garnered from prior employment experience or academic training.
- Expert in the analysis, utilization, safety and troubleshooting of NMR instrumentation and NMR method development.
- Act as a primary technical resource for and be a point of contact for QC and external departments.
- In depth subject matter expertise in a variety of types of routine instrumentation including NMR, HPLC, GC, FTIR, FTNIR, water content and associated software systems like Chromeleon or Empower.
- On assignment by management, possesses the ability to 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 that may be introduced in the QCC department.
- Make scientific recommendations to management and other departments regarding Quality Control laboratory protocols and test procedures. Assist laboratory management in test assignments based on commercial and stability time lines 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.
- Upon delegation, assume a supporting role to the management team on activities such as the issuance of COA's, review of Change controls, test methods and specifications.
- Provide support to the QC department for the evaluation and implementation of new technological innovations in laboratory automation systems, documentation systems and other technologies.
- Perform change assessments and change controls for changes in testing, documents and specifications.
- Validate and install new laboratory instrumentation systems including development of new test methods for the associated instrumentation.
- Serve as a project team member and collaborate with CORE teams throughout the development lifecycle.
- Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
- Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
- Escalate and communicate items that arise per the timelines specified in the department escalation strategy.
- 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
- Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational 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
- Accountable for maintaining a positive atmosphere of teamwork, camaraderie and respect towards co-workers.
- Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Respond to spills per CP [redacted] Chemical Spill Response.
- Perform various other duties as assigned.
Knowledge, Skills & Abilities- Expert knowledge of NMR instrumentation and data analysis.
- A demonstrated knowledge of fundamental chemistry pertaining to specific products and assays conducted in the Tolmar QC laboratory.
- Possesses 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
- Knowledge in analytical method validation and instrument qualification
- Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology
- Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work
- Ability to grasp and enhance the technical expertise required for new products in the pipeline in order to support QC functions as per business needs.
- High level of proficiency in Quality Control laboratory procedures and testing techniques.
- Hands-on, operational and troubleshooting knowledge of analytical instrumentation within the QC department. Ability to evaluate and adapt new technologies that are to be introduced to the department based on business needs.
- Knowledge of analytical troubleshooting and product investigation
- Expert knowledge of cGMP practices, regulatory and ICH guidelines.
- An excellent grasp on USP and other compendial methods.
- Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, plate readers, and MODA.
- Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
- 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.
Education & Experience- Previous in depth NMR testing and troubleshooting experience is required.
- BS, MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
- BS combined with 10 or more years Pharmaceutical cGMP laboratory work: Masters combined with 8 or more years Pharmaceutical cGMP laboratory work: or PhD: and 5 or more years Pharmaceutical cGMP laboratory work.
- 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- Working conditions are typical for an office environment in addition to a laboratory setting to include 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: 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.
