Description
B. Braun Medical, Inc.Company: B. BRAUN MEDICAL (US) INC
Job Posting Location: Irvine, California, United States
Functional Area: Research and Development
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 10532
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com
Position Summary:
This research scientist position is within the B. Braun Pharmaceutical Research & Development department. The incumbent will be involved in drug product activities related analytical method development, optimization, validation, extractables/leachables studies, impurity identification, etc. to support Pharmaceutical R&D portfolio from the innovation phase to commercial product realization (ParaI-IV ANDA, PAS, 505b (1)/(2) NDA categories). The pharmaceutical portfolio includes: Injectable drugs & Premixes, Duplex® systems, parenteral drugs and nutrition, and Intravenous fluid replacement therapies.
This position reports to Cindy Li, Principal Scientist II and will be fully onsite Monday Friday, 8 AM to 5 PM.
Responsibilities: Essential Duties
Perform analytical method development, verification/validation using a wide variety of analytical techniques, such as HPLC. GC, FTIR, UV, LC/MS, GC/MS, etc. for container closure materials, drug substance, and drug product pharmaceutical formulation.
Conduct Extractables studies for container closure/packaging materials such as resin, plastic film, stoppers, label inks, adhesives, etc. and leachables studies for drug product pharmaceutical formulation.
Conduct impurities identification in related to drug substance, drug products, extractables/leachables.
Plans, organizes, and conducts analytical experiments and research activities to support drug product development and commercialization.
Review data, notebooks, and reports to ensure compliance with specifications, standard operating procedure, and regulatory requirements
Author pertinent protocols, reports, and relevant CMC sections for regulatory filings.
Collaborates with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques/products.
Expertise: Knowledge & Skills
Requires working knowledge of professional field and pharmaceutical industry in cGMP and/or R&D environment.
Working knowledge of chemical theories, concepts, test methods and instrumental methods,analytical and research skills.
Experience in chemical impurity identification and characterization with LC/MS, GC/MS in related to extractables/leachable's preferred.
Knowledge of USP, EP, FDA CFR & ICH, ISO regulations and guidelines in regarding extractables/leachables and impurities.
Experience in analytical method development/ optimization, validation, troubleshooting, etc.
Proficiency with Microsoft Office Applications (e.g. Word, Excel, Power Point).
Strong communication (written and verbal), attention to detail and organizational skills as demonstrated in writing project proposals, protocols and reports.
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
Judgement is required in resolving complex problems based on experience.
Required:
Ph.D. or M.S. degree in analytical chemistry, organic chemistry, pharmaceutical chemistry or a related science discipline.
4-6 years related experiences in pharmaceutical industry preferred.
Compensation: $108,400 - $118,400
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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