Scientist III, QC Labs

Hikma; Columbus (OH); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Performance bonus

401(k) with company match

Generous PTO

Parental leave

Comprehensive benefits

Zusammenfassung

Hikma Pharmaceuticals USA, Inc. in Columbus, OH seeks a Scientist III, QC Labs to perform qualitative and quantitative testing of APIs, starting materials, and finished products in a GMP environment.

You will review analytical data, maintain notebooks, and assist with method development and troubleshooting while ensuring regulatory compliance. The role requires strong analytical skills, experience with HPLC/UV/GC, and ability to train junior scientists.

Qualifikationen

• Experience performing analytical testing in a GMP pharmaceutical environment.
• Strong knowledge of analytical methods and data integrity practices.
• Ability to review and ensure compliant documentation and reporting.

Aufgaben

• Perform qualitative and quantitative testing of APIs, starting materials, packaging components and finished products.
• Review analytical data against specifications and procedures; resolve discrepancies.
• Maintain laboratory notebooks and generate technical reports for method improvements.
• Troubleshoot analytical techniques and operate laboratory equipment per standards.
• Approve batch records and release analytical documentation per procedure.

Kenntnisse

Quality control

Analytical testing

Laboratory documentation

cGMP knowledge

Team training

Ausbildung

BS in Chemistry

High School Diploma with GMP experience

Tools

Empower

LabWare

Chromatographic Data Systems

Jobbeschreibung

Job Title: Scientist III, QC Labs

Location: Columbus, OH

Job Type: Full time

Req ID: 12890

About Us:

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.

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.

Key Responsibilities:

• Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for API's, starting 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:

• 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.

Qualifications:

• High School Diploma or equivalent with ten 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 candidate must be able to perform compendia and non-compendia testing for multiple projects at one time.

Preferred Qualifications:

• BS in Chemistry or in a science-related field with five years GMP pharmaceutical analytical chemistry experience. The candidate must be able to perform compendia and non-compendia testing for multiple projects at one time.

What We Offer*:

• 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. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). 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
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave
• Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.