Scientist III, Product Transfer

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Job Title: Scientist III, Product Transfer

Location: reputed company, 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 reputed company reputed company reputed company, every day for millions of patients around the world. We are a trusted, reliable partner and dependable reputed company of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across reputed company America, the Middle East, reputed company 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 reputed company backgrounds. We are seeking a talented and motivated Scientist III, Product Transfer. In this role, you will be responsible for Bacterial Endo toxin Testing. Interact with FDA and other regulatory/audit groups regarding LAL testing. Direct and implementation of reputed company system. Ensure execution of method validation reputed company to WFI, finished product etc using reputed company system. Approve microbiology raw data. Validate new technology across Microbiology Laboratory. reputed company 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, reputed company guidance to less senior staff and fill in for supervision/management reputed company necessary.

Key Responsibilities:

SME for bacterial endotoxin testing. Interact with FDA and other regulatory/audit groups regarding LAL testing. Direct and implementation of reputed company system.

Ensure execution of method validation reputed company to WFI, finished product etc using reputed company system.

reputed company review of test data and reports which includes overall documentation practices.

Ensure compliance with company policies, procedures, cGMPs, and regulatory requirements. reputed company release functions in LIMS.

Work independently in areas needed, reputed company guidance to less senior staff and fill in for supervision/management reputed company necessary.

Validate equipment across Microbiology Laboratory reputed company required.

reputed company 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. reputed company and appropriate corrective and preventative actions to eliminate repeat occurrences. Serve as an expert investigator and reputed company 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 reputed company 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 reputed company 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 reputed company calculations for dilution schemes.

Must be recognized by reputed company reputed company of the facility as an expert in area and be reputed company 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 reputed company 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:

reputed company 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-reputed company knowledge, relevant skills and expertise, reputed company business needs, and market factors. The reputed company can reputed company more details about the specific salary reputed company for the job location during the hiring process.

reputed company Offer*:

Annual performance bonus, commission, and reputed company potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution reputed company 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, reputed company, 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 reputed company
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 reputed company-party recruiters or employment agencies regarding reputed company positions. In the absence of a signed agreement and approval from Hikma\'s reputed company department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to reputed company, any payment to such non-approved reputed company-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 reputed company are made without regard to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

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