Scientist III, QC Labs

HIKMA•Columbus, OH

14h

About The Position

Hikma Pharmaceuticals USA Inc. is seeking a Scientist III, QC Labs to perform quality-control laboratory workflows supporting the testing of raw materials and finished products while meeting customer requirements and regulatory compliance standards. The role performs qualitative, quantitative, chemical, and physical testing of APIs, starting materials, packaging components, and finished products according to compendia or specifications. It also supports departmental goals and site metrics for right-first-time performance, productivity, testing turnaround, throughput time, and QSDB. The Scientist III reviews analytical testing documentation, resolves discrepancies, maintains laboratory records, follows current procedures and cGMP requirements, authors technical reports for analytical-method improvements, and performs investigations, troubleshooting, and advanced analytical techniques. The role approves batch records and reviews and releases analytical documentation. The position has no direct reports, but includes training lower-level scientists and evaluating their skills. The successful candidate works independently with supervision, applies scientific judgment, collaborates with a team, and may lead RRRFTT meetings to discuss laboratory deviations with stakeholders.

Requirements

High school diploma or equivalent and ten years of GMP pharmaceutical analytical chemistry experience.
Experience executing analytical methods, with supervision for evaluation and release of APIs or pharmaceutical finished products.
Ability to perform compendia and non-compendia testing across multiple projects at one time.
Required analytical experience for APIs: UV, HPLC, GC, UPLC, KF, FTIR, advanced data review, lead investigator, and disposition for packaging/labeling.
Required analytical experience for pharmaceutical products: HPLC, UPLC, chromatographic data systems, advanced data review, and lead investigator.
Ability to work independently using a team approach and handle multiple projects in a fast-paced environment.
Excellent written and verbal communication skills.
Ability to work with supervision using scientific judgment and professional competency.

Nice To Haves

BS in Chemistry or a science-related field with five years of GMP pharmaceutical analytical chemistry experience; ability to perform compendia and non-compendia testing across multiple projects at one time.
Experience with Empower chromatographic data systems is preferred.
Experience with LabWare laboratory information management systems is preferred.
Additional API techniques: particle size, ICP, AA, viscosity, XRD, and packaging component testing.
Additional pharmaceutical techniques: GC, IC, droplet size distribution, automated actuators, FTIR, and microscopes.
Knowledge of critical functions and variables for each equipment type, and instrument/method troubleshooting ability.

Responsibilities

Perform qualitative, quantitative, chemical, and physical testing of APIs, starting materials, packaging components, and finished products according to compendia or specifications.
Meet department goals and site metrics for RFT and productivity, including testing turnaround, throughput time, and QSDB.
Perform peer review of analytical testing documentation and resolve discrepancies.
Review analytical documentation against specifications, analytical procedures, laboratory practices, training, and procedures.
Maintain orderly laboratory data in notebooks, worksheets, and documents, accurately using current DPs, SOPs, and cGMP regulations.
Author technical reports for analytical-method improvements.
Conduct investigations, troubleshooting, and advanced analytical techniques.
Use laboratory equipment and techniques, and document work, according to laboratory methods and standards.
Approve batch records and review and release analytical documentation according to specifications, analytical procedures, and laboratory practices.
Work independently using a team approach and manage multiple projects in a fast-paced environment.
Organize and lead RRRFTT meetings to discuss laboratory deviations with stakeholders.
Train lower-level scientists in analytical techniques and evaluate their skills.

Benefits

Annual performance bonus, commission, and share potential.
Auto-enrollment in a Hikma-sponsored 401(k) at a pre-tax contribution rate of 4% of eligible pay; Hikma matches 100% of the first 6% of eligible pay contributed.
Paid time off starting at 20 days, prorated based on hire date, with additional days at work milestone anniversaries.
Three personal days, prorated based on hire date.
Eleven company-paid holidays.
Health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and voluntary benefits.
Employee discount program.
Wellbeing rewards program.
Career advancement and growth opportunities.
Tuition reimbursement.
Paid maternity and parental leave.