Chemist II

Job Title Chemist II

Location:

Bedford, OHJob Type: Full-time

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.

Perform functions of the Chemistry Laboratory and conduct chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming components and raw materials to finished goods and stability. Execute process and cleaning validation and/or test method validation under the direction of supervision. Write/revise standard operating procedures, forms and exception reports. The duties also include equipment maintenance and LIMS management.

• Conduct critical chemical and physical analyses on incoming components, raw materials, initial, in-process, final products and stability, and samples collected from water for injection systems at Hikma manufacturing facilities, along with customer compliant, foreign vials and retain samples. Work under minimum supervision.
• Use sophisticated laboratory instrumentation (HPLC, GC, FTIR, AA, UV/Vis, ICP-MS, etc.) and computer systems to collect and record data.
• Perform advanced assays requiring precise analytical skills and understanding of chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner. Enter data in LIMS.
• Execute validation studies in support of manufacturing processes, R&D projects including cleaning and process validation and method validation.
• Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
• Maintain data integrity and ensure compliance with company SOPs and specifications, USP, Ph.Eur, FDA, GLP, GDP and cGMP regulations.
• Conduct reference standard qualifications. Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required.
• Investigate deviations and write exception documents.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Perform laboratory audits as required. Audit and update, as required, plant SOPs and Job Aids.
• Perform equipment maintenance and calibrations as required, troubleshoot and resolve instrumentation issues and participate in new instrument qualifications.

• Proficient in wet and instrumental methods of analyses
• Advanced laboratory skills, basic knowledge of statistical method.
• Strong technical problem-solving skills
• Ability to handle multiple tasks concurrently, and in a timely fashion
• Computer literate.
• Must be able to communicate effectively with supervisors and peers.
• Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.
• Must be able to accommodate a flexible work schedule (weekends, shift, etc.) which may be required for business needs

• Manage stability programs in accordance with ICH Q1A(R2) and Hikma procedures.
• Maintain stability schedules for commercial products, validation batches, and stability commitments.
• Coordinate sample pulls and testing timelines (e.g., 0, 3, 6, 12, 24, 36 months).
• Ensure alignment with regulatory commitments (ANDA/NDA submissions).

• Bachelor’s Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years’ experience, or master’s degree in Chemistry, or…