Scientist III, Product Transfer - Injectables in Bedford

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.

Description: We continue to be 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, Product Transfer. In this role, you will be responsible for Bacterial Endotoxin Testing. Interact with FDA and other regulatory/audit groups regarding LAL testing. Direct and implement Kinetic system. Ensure execution of method validation related to WFI, finished product etc using kinetic system. Approve microbiology raw data. Validate new technology across Microbiology Laboratory. Perform laboratory and manufacturing investigations for OOS and OOL microbiological other exceptions. Troubleshoot microbiological equipment issues. Resolve problems and implement corrective and preventive actions. Write/revise standard operating procedures, forms, protocols, test methods, and change controls as needed. Work independently in areas needed, provide guidance to less senior staff and fill in for supervision/management when necessary.

Key Responsibilities:

• SME for bacterial endotoxin testing.
• Interact with FDA and other regulatory/audit groups regarding LAL testing.
• Direct and implement Kinetic system.
• Ensure execution of method validation related to WFI, finished product etc using kinetic system.
• Perform review of test data and reports which includes overall documentation practices.
• Ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.
• Perform release functions in LIMS.
• Work independently in areas needed, provide guidance to less senior staff and fill in for supervision/management when necessary.
• Validate equipment across Microbiology Laboratory when required.
• Perform laboratory and manufacturing investigations for OOS and OOL microbiological and environmental monitoring results and other exceptions.
• Execute appropriate investigative testing to find or support root cause.
• Develop appropriate corrective and preventative actions to eliminate repeat occurrences.
• Serve as an expert investigator and perform trending of investigations.
• Write and revise standard operating procedures, forms, protocols, test methods, and changes controls.
• Participate in teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

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:

• Education: BS in Microbiology or advanced degree.
• Experience: Pharmaceutical Microbiology and/or Environmental Monitoring experience in injectable manufacturing. Must have 5 to 10 years of experience in laboratory testing experience, Environmental Monitoring experience and experience in validation of Microbiology test equipment. Must have experience in product validation testing and performing complex calculations for dilution schemes.
• Must be recognized by all levels of the facility as an expert in area and be able to demonstrate leadership.
• Excellent organizational and project management skills and ability to handle multiple projects.
• Must have excellent writing skills and ability to present data in a logical manner.
• Good interpersonal, communication, influencing, negotiation skills.
• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Demonstrated effectiveness in task completion, decision making, and problem solving.
• Working knowledge of FDA regulations, application of GLPs and GMPs.
• Experience interacting with personnel from regulatory agencies preferred.

Compensation: Base Salary: $59,900 to $120,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors.

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.

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.