Job Title Chemist II
Location: Bedford, OH
Job 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.
JOB PURPOSE:
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.
Essential Duties and Responsibilities:
- 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.
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
Preferred Qualifications:
Stability Program Coordination
- 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).
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Education and EXPERIENCE:
- 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 Biological Sciences, with 0-3 years’ experience.
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 3% 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.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third parties in the event a candidate they refer is hired by Hikma
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.
