Sr. Scientist I - Mass Spec

Alcami Corporation

1d•Onsite

About The Position

A Senior Scientist I - Mass Spec is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist III is also required to work on method development/method validation projects. For this position, HPLC, LC/MS and GC/MS based methodologies are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).

Requirements

Bachelor’s degree in Chemistry with 8+ years of experience, or Master’s degree with 4+ years of experience, or Ph.D. with 2+ years of experience required.
2+ years of experience cGMP in a pharmaceutical or regulated environment required.
Excellent verbal and written communication and documentation skills required.
Excellent detail orientation and organizational skills required.
Excellent problem-solving and basic trouble-shooting ability required.
Excellent knowledge of laboratory equipment and safety required.
Expert knowledge of Laboratory Documentation is required.
Ability to develop and implement new methods/processes required.
Mass spectrometry (GC/MS, LC/MS, triple quadrupole, QTOF) skills and quantitative/qualitative work experience.
Ability to plan and manage multiple tasks for timely achievement of results.
Working knowledge of cGMP in a pharmaceutical or regulated environment required.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Nice To Haves

CDMO experience is preferred.

Responsibilities

Uses advanced skills in multiple techniques: HPLC, LC/MS and GC/MS assays for residual solvents, nitrosamines, genotoxic impurities, identification and characterization of unknown impurities.
Develops analytical methodology for analysis via HPLC, LC/MS and GC/MS.
Performs quantitative and qualitative mass spectrometry work using specific instrument types (i.e. triple quadrupole and QTOF systems)
Performs GMP review of solutions and chromatography.
Develops and validates methods, test procedures, protocols, and reports.
Understands the theoretical basis of methods/experiments.
Maintains strong knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
Analyzes information for technical correctness and accuracy.
Evaluates and interprets data.
Achieves results by solving problems of a diverse scope.
Interacts with clients and participates in regulatory agency and/or client audits.
Leads investigations and root cause analysis.
Drives initiatives outside of standard work function.
Maintains a safe, clean, and organized work environment free of safety hazards.
Safely handles potent compounds.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.