Senior Chemist - Project-Based Contractor

Overview:

The Senior Chemist is an ad hoc, project-based independently contracted role serving as Groenakker's senior technical authority for the chemical characterization of medical devices. Work is assigned per project rather than on a fixed weekly schedule. As part of Groenakker's global Operations team, this role reviews and interprets analytical chemistry data generated by contract laboratories, resolves spectra into defensible compound identifications, and judges whether a chemistry data package fully satisfies ISO 10993-18 and the associated FDA guidance before it is relied upon for toxicological risk assessment or regulatory submission. The scope of this role is medical device chemical characterization specifically, rather than general analytical, pharmaceutical, or industrial chemistry.

 Engagement Model:

1. Work is assigned ad hoc on a project-by-project basis. There is no fixed weekly hour commitment, no minimum guaranteed volume of work, and no set schedule.

2. The role is fully remote and open to candidates located anywhere in the world. The contractor is responsible for their own tax status, business registration or entity of record, and any employment, insurance, or licensing obligations applicable in their jurisdiction.

3. Sufficient overlap with United States Eastern Time is required to support client calls and internal review; a minimum of three overlapping working hours per business day is expected.

4. Professional written and spoken English fluency is required, as all deliverables and client communications are produced in English.

Essential Duties and Responsibilities:

1. Review extractables and leachables data packages produced by contract laboratories, including GC-MS, headspace GC-MS, LC-MS, LC-UV/HPLC, ICP-MS, and ICP-OES data sets, and judge their scientific and regulatory adequacy.

2. Deconvolute mass spectra and chromatographic data to generate sound compound identifications, interpreting fragmentation patterns, applying spectral library matching, and requiring orthogonal confirmation such as retention index or authentic standard before an identification is treated as confirmed.

3. Assign and document the confidence level of every identification — confirmed, tentative, or unknown — and ensure unresolved peaks are carried forward transparently rather than dismissed.

4. Verify derivation of the Analytical Evaluation Threshold, including dose-based calculation, uncertainty factor selection, and the effect of estimated response factors on semi-quantitation.

5. Assess method suitability and data quality, including system suitability, calibration, internal standards, spike recovery, method blanks, carryover, limits of detection and quantitation, and validation status.

6. Confirm that extraction design meets ISO 10993-12, including surface-area-based sample sizing, extraction ratio, vehicle polarity coverage, and the justification for exaggerated versus exhaustive extraction.

7. Evaluate chemistry data packages against ISO 10993-18 and the FDA guidance “Use of International Standard ISO 10993-1” (2023), issue written deficiency findings, and drive laboratory corrective action to closure.

8. Apply elemental analysis requirements for metals and inorganic constituents, including ICP-MS and ICP-OES data review and USP <232> and <233> or ICH Q3D limits where applicable.

9. Apply ISO 18562-2 and ISO 18562-3 requirements for particulate matter and volatile organic compounds in breathing-gas pathway devices.

10. Provide identified and quantified constituent data to toxicology in a form suitable for risk assessment under ISO 10993-17, and resolve chemistry questions arising during that assessment.

11. Author the chemical characterization content of regulatory submissions and defend methodology and identifications in FDA Pre-Submissions, 510(k) reviews, Additional Information requests, and European MDR technical documentation.

12. Support selection, qualification, and technical oversight of contract laboratories, including protocol and method review prior to study start.

13. Assess the impact of changes to standards, guidance, and FDA recognition status — for example the partial recognition of ISO 10993-1:2025 under Recognition No. 2-313 — on active client chemistry programs.

14. Train and mentor junior chemists and reviewers on data interpretation, identification confidence, and documentation standards.

15. Perform other project-related duties as agreed within the applicable Statement of Work.

Basic Qualifications:

1. 8 Years hands-on analytical chemistry experience, including direct chemical characterization of medical devices.

2. A bachelor's degree or higher in analytical chemistry, chemistry, or a closely related field.

3. Demonstrated expertise interpreting GC-MS, LC-MS, and ICP-MS or ICP-OES data, including spectral deconvolution and defensible compound identification, beyond instrument operation alone.

4. Working command of ISO 10993-18 and the related FDA biocompatibility guidance as applied to regulated medical devices.

5. Demonstrated ability to critically evaluate third-party laboratory data quality and document deficiencies.

Preferred Knowledge Skills and Abilities:

1. An advanced degree (master's or doctorate) in analytical chemistry or a closely related field.

2. Experience defending chemical characterization methodology and identifications directly with FDA reviewers in a Pre-Submission or Additional Information exchange.

3. Familiarity with ISO 18562, USP <87> and <88>, USP <232> and <233>, and ICH Q3D.

4. Experience with analytical method development, validation, and transfer.

5. Experience with contract laboratory qualification and audit.

6. Familiarity with ISO 10993-17 toxicological risk assessment and the chemistry inputs it requires.

7. Experience curating or critically applying spectral libraries and retention index data.

8. Excellent communication skills and customer-oriented empathy.

9. Ability to effectively work remotely with limited supervision while managing concurrent client projects.