ABOUT US:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

DESCRIPTION:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Scientist III, QC Labs to join our team. In this role, you will be responsible for performing 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.

QUALIFICATIONS:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• High School Diploma or equivalent with ten years GMP pharmaceutical analytical chemistry experience.
• BS in Chemistry or in a science-related field or equivalent with five years GMP pharmaceutical analytical chemistry experience.
• The work-related experiences required include the execution of analytical methods, with supervision for evaluation and release of Active Pharmaceutical Ingredients (APIs) or Pharmaceutical Finished Products (FPs). The colleague must be able to perform compendia and non-compendia testing for multiple projects at one time.

Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for API’s,

• ing materials, packaging components and finished products.
• Meet core department goals and site metrics for RFT 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. Accurate use of current DPs, SOPs, 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)

• Experience with the following analytical analyses and processes is required:

• • 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 Revies, Lead Investigator
• Additional experience with the following analytical techniques is highly desired:
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• 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 is also highly desired as well as instrument/method troubleshooting ability.
• Must be able to work independently using a team approach to accomplish tasks assigned. Must possess the ability to work on multiple projects in a fast-paced environment.
• Must possess excellent written and verbal communication skills. Must be able to organize and lead RRRFTT meetings to discuss laboratory deviations with stakeholders.
• The candidate must have the ability to work with supervision using scientific judgment and professional competency. This position has no direct reports but does require training lower-level scientists in various analytical techniques and evaluating their skills.