Scientist III, QC Labs

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty, and branded pharmaceutical products that hospitals, physicians, and pharmacists need to treat their patients across North America, the Middle East, North Africa, and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

About the role

We are seeking a talented and motivated Scientist III, QC Labs to join our team. In this role, you will perform workflow processes within the quality control laboratory to meet customer requirements by supporting the testing of raw materials and finished products while ensuring regulatory compliance standards are met.

Responsibilities

• Perform qualitative, quantitative chemical, and physical testing as specified by compendia or specification for APIs, starting materials, packaging components, and finished products.
• Meet core department goals and site metrics for RFT (Right First Time) and productivity (testing turn-around, throughput time, QSDB).
• Perform peer review of analytical testing documentation and resolve discrepancies.
• Review analytical documentation against specification, analytical procedures, and laboratory practices (training and procedures).
• Maintain laboratory data in an orderly manner in laboratory notebooks, worksheets, and documents.
• Ensure accurate use of current DPs, SOPs, and cGMP regulations.
• Author technical reports for analytical methods improvement.
• Perform investigational, troubleshooting, and advanced analytical techniques.
• Proper use of laboratory equipment, techniques, and documentation according to laboratory methods and standards.
• Approval of batch records.
• Review and release analytical documentation as per specification, analytical procedures, and laboratory practices (training and procedures).
• Work independently using a team approach to accomplish assigned tasks.
• Organize and lead RRRFTT meetings to discuss laboratory deviations with stakeholders.
• Train lower-level scientists in various analytical techniques and evaluate their skills.

Required experience with the following analytical analyses and processes:

• For APIs: UV, HPLC, GC, UPLC, KF, FTIR, Advanced Data Review, Lead Investigator, Disposition (Packaging / Labeling).
• For Pharmaceutical products: HPLC, UPLC, Chromatographic Data Systems (Empower preferred), Laboratory Information Management Systems (LabWare preferred), Advanced Data Review, Lead Investigator.

Highly desired additional experience with the following analytical techniques:

• For APIs: Particle size, ICP, AA, Viscosity, XRD, packaging component testing.
• For Pharmaceuticals: GC, IC, Droplet Size Distribution, Automated Actuators, FTIR, Microscopes.

Knowledge of the critical functions/variables for each type of equipment and instrument/method troubleshooting ability is also highly desired.

Requirements

• High School Diploma or equivalent with ten years of GMP pharmaceutical analytical chemistry experience.
• Experience in the execution of analytical methods, with supervision for evaluation and release of Active Pharmaceutical Ingredients (APIs) or Pharmaceutical Finished Products (FPs).
• Ability to perform compendia and non-compendia testing for multiple projects simultaneously.
• Ability to work on multiple projects in a fast-paced environment.
• Excellent written and verbal communication skills.
• Ability to work with supervision using scientific judgment and professional competency.

Preferred Qualifications

• BS in Chemistry or a science-related field with five years of GMP pharmaceutical analytical chemistry experience.

Benefits

• Annual performance bonus, commission, and share potential.
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay, with Hikma matching 100% of the first 6% of eligible pay contributed.
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date), with additional days granted upon reaching work milestone anniversaries.
• 3 personal days (prorated based on hire date).
• 11 company-paid holidays.
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits.
• Employee discount program.
• Wellbeing rewards program.
• Tuition reimbursement.
• Paid maternity and parental leave.

Eligibility requirements apply to some benefits and depend on job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.