Scientist II - Analytical Services

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 Scientist uses in-house standard operating procedures, compendial documents, industry guidances and pharmaceutical industry knowledge to perform tasks.

The Scientist fosters an environment of safety and company culture.

Essential Duties & Responsibilities

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.

• Adhere to validated test methods, standard operating procedures, and applicable industry guidance.
• Knowledgeable in the execution of compendial methods, specifically USP and EP.
• Independently perform sample analyses.
• Efficiently analyze samples of drug product, drug substance, and / or excipient(s).
• Assist other departments in analyzing samples, as requested.
• Maintain and review laboratory notebooks according to cGMP standards and in-house standard operating procedures (SOPs).
• Record detailed observations. Tabulate, analyze, review, and interpret data from analytical tests.
• Lead analytical test method design, development, qualification, and validation.
• Perform equipment troubleshooting, maintenance, and minor repairs.
• Assist the Quality Control (QC) laboratory in troubleshooting test method issues.
• Efficiently write and review technical reports, summaries, protocols, test methods, standard operating procedures, and other documents for use in the company or submission to government agencies.
• Use technical discretion in designing, executing, and interpreting experiments that contribute to project strategies.
• Participate in required trainings.
• Serve as contact for vendors and contract laboratories.
• Interact closely with project teams across departments and outside testing laboratories.
• Interpret, review, and discuss data from outside testing laboratories.
• Mentor, train, and coach others.
• Participate in scientific conferences if requested.
• Provide analytical support to Formulation Development and interact with team members in exchanging technical expertise.
• Serve as a subject matter expert (SME) (instrumentation, methodology, guidance, etc.) and train others in several areas of expertise
• 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.
• Allocate lab resources effectively (staff, budget, materials, etc.).
• 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.
• Participate 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.

Responsible for daily activities and supervising staff that are hazardous waste generators and / or handlers. Respond to spills according to the Chemical Spill Response procedure.

• Perform report, protocol, test method, and specification approvals.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

Knowledge

• Demonstrated proficiency in operating analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-Vis spectrophotometry, TLC, Karl Fischer titration, rheometry.
• Proficient with sample preparation from a variety of matrices.
• 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.
• Extensive experience with laboratory and wet chemistry techniques (, weighing, volumetric glassware, titrations, etc.).
• Experience in equipment troubleshooting, maintenance, and repairs.
• 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, laboratory equipment, and raw data handling.

Skills

• 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.

Core Values

• The Scientist II is expected to operate within the framework of Tolmar’s Core Values :
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

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

Working Conditions

Laboratory and office setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

Compensation and Benefits

• Annual Pay Range : $115,000 - $122,000
• Bonus Eligible
30+ days ago