Principal Scientist, GC-MS SME

What Chemistry Services contributes to Cardinal Health

Chemistry services performs laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of QRMA, Chem Services develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterizes medical devices, materials, and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilized during clinical use. The Chemistry Service will also use specialized instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical.  Chemistry Services is a part of QRMA Scientific Services.

Responsibilities

As the Gas Chromatography - Mass Spectrometry (GC/MS) subject matter expert (SME) in Advanced Analytical Operations (AAO), produces highest quality GC/MS Analytical Data;

• Responsible for the operation and maintenance of GC/MS instrumentation, and other related GC configurations, e.g. Headspace gas chromatography with flame ionization detection (HS-GC-FID), and GC sample management systems with AAO.

• Competent and knowledgeable expert both in terms of the instrument’s scientific and technical fundamentals of operation and in terms of instrument operation, and data interpretations.

• Develops and qualifies methods used in routine and challenging testing situations (e.g., low sensitivities, complex sample matrices).

• Perform testing at or beyond the instrument vendor’s specifications.

• Performs both routine, protocol driven testing and specialized method development and testing in the analytical area of responsibility.

• Interprets volatiles (VOCs) results from HS-GC/MS, volatiles and semi-volatiles (VOC and SVOCs) from gas chromatograph mass spectrometry (GC-MS) and understands non-volatiles (NVOCs) interpretation from liquid chromatograph mass spectrometry (LC-MS) results with high level of proficiency.   

• Performs data compilation, review and performs trend analysis on data as applicable.

• Ensures that the necessary analytical tests are done according to the test specification, test method and working instructions and in a timely and accurate manner.

• Works with other AAO staff members to develop and achieve often challenging and competing milestones.

• Authors and investigates laboratory and instrumentation discrepancies and other nonconformances.  

• Trains and mentors junior staff members.

• Works with Chemistry Lab Manager to develop and defend operating and capital expense plans, representing the needs for GC Analysis.

• Manages operational and capital expenditures to budget.

• Serves as the AAO GC/MS SME/liaison to projects teams; establishing support needs, developing, and providing detailed support plans, negotiating support timelines, performing the specified testing, communicating test results, and providing test result interpretations.

Qualifications

• M.S. or Ph.D. in analytical chemistry or a related field. Advance degree and specified experience preferred.

• 5+ years of analytical laboratory experience performing GC/MS analyses to support pharmaceutical drug product and/or medical device development and registration for M.S.; 3+ years of experience for Ph.D.

• GC-HS experience preferred.

• Gerstel headspace experience desired but not required.

• Comprehensive experience in volatile and semi-volatile testing of pharmaceutical products and/or medical devices.

• Experience with EO residual (and related analytes) preferred.

• Extensive experience operating and maintaining the specific brand and models of relevant instruments housed within AAO (e.g., Agilent GC systems and advanced autosampler systems).

• Proficient in the use of instrumental data systems, including data acquisition, analysis and processing.

• Lab experience includes research in GMP/QSR environment; leadership of technical teams, and project management experience is desirable.

• Understanding of the current theory and practice of chemical characterization and toxicological risk assessment medical devices and Extractables and Leachables testing of drug products and/or medical devices as outlined in relevant regulatory, compendial or industry standards including e.g., USP <1663> and <1664>, ISO 10993-1, ISO 10993-17, and ISO 10993-18.

• Demonstrated record of extensive and current training in the operation and maintenance of relevant AAO instrumentation in area of expertise.

• Requires excellent written and oral communication skills. The incumbent has daily contact with a variety of research personnel, technical peers, and appropriate managerial personnel, as well as frequent contact with customers, clients, vendors, and suppliers.

• Must be able to convey recommendations, data, observations, results, and problems accurately and effectively to co-workers and customers.   

• Proficient in scientific computing and technical computing and publishing software (e.g. Microsoft Office and LIMS).

• Strong communication and interpersonal skills.  Can operate independently and as a member of high performing project teams.

What is expected of you and others at this level

• Produces high quality data and provides expert interpretation of generated data in area of expertise (GC/MS and related GC Analysis).

• Operates GC/MS instruments to meet the challenges of high throughput routine testing and high challenge special case testing.  

• Maintains GC instruments to enable the production of high quantity and high-quality technical data with minimal downtime.

• Interprets results from GC/MS testing with high level of proficiency.

• Schedules and manages testing workflow to meet challenging and competing project timelines.

• Reports test data in a form and format that facilitates the use of the data by team members.

• Develops instrument testing protocol and methods, stand operating procedures (SOPs), work instructions and other instrument documentation.

• Ensures that the necessary testing is performed according to the test specification, test method and working instruction and to ensure testing is completed in a timely and efficient manner.

• Authors technical protocols and reports.

• Works with a team of chemists to design and implement analytical strategies.

• Serves as primary SME contact for scientific and regulatory issues.

• Possess profound and current operational knowledge for relevant analytical instrumentation, including their operational, data, acquisition, data processing, and data reporting software and systems.

• Possess profound and current knowledge of global regulatory requirements for gas chromatography testing of medical devices and pharmaceutical products.

• Possess a working knowledge of analytical characterization of materials, plastics, polymers, material/plastic additives and metals and extractables/leachable studies of medical devices and impurities/degradants of pharmaceutical products preferred.

• Possesses a working knowledge of FDA, ISO, and EU MDR regulatory requirements as applicable to medical device and pharmaceutical products preferred.

• Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures.

• Works with minimal degree of supervision. Has latitude to make decisions in exceptional circumstances within established guidelines.

• Mentors and develops junior team members.

• Establishes, implements, and achieves a Professional Development Plan that maintains the incumbent’s high level of scientific, technical, operational, and regulatory knowledge and expertise.

Anticipated salary range: $136,500 - $194,500

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage

• Paid time off plan

• Health savings account (HSA)

• 401k savings plan

• Access to wages before pay day with myFlexPay

• Flexible spending accounts (FSAs)

• Short- and long-term disability coverage

• Work-Life resources

• Paid parental leave

• Healthy lifestyle programs

Application window anticipated to close: 10/4/2024 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.