Research Scientist I
Califesciences, Irvine, CA, United States
Research Scientist I
Company:
B. Braun Medical Inc. (US)
Location:
Irvine, California, United States
Functional Area:
Research and Development
Working Model:
Onsite
Days of Work:
Wednesday, Tuesday, Thursday, Friday, Monday
Shift:
5X8
Relocation Available:
No
Requisition ID:
10532
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 (Parui-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
Perform analytical method development, verification/validation using a wide variety of analytical techniques, such as HPLC, GC, FTIR, UV, LC/MS, GC/MS, 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 impurity identification related to drug substance, drug products, extractables/leachables.
Plan, organize, and conduct analytical experiments and research activities to support drug product development and commercialization.
Review data, notebooks, and reports to ensure compliance with specifications, standard operating procedures, and regulatory requirements.
Author pertinent protocols, reports, and relevant CMC sections for regulatory filings.
Collaborate with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques/products.
Expertise: Knowledge & Skills
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 related to extractables/leachables preferred.
Knowledge of USP, EP, FDA CFR & ICH, ISO regulations and guidelines regarding extractables/leachables and impurities.
Experience in analytical method development/optimization, validation, troubleshooting, etc.
Proficiency with Microsoft Office Applications (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 assist in orienting, training, assigning & checking the work of other peers.
Judgement required in resolving complex problems based on experience.
Required Qualifications
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 geographic differential. Compensation decisions are dependent on facts and circumstances of each case. The range provided is a reasonable estimate.
Benefits
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 at www.bbraunusa.com.
EEO Statement
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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Company:
B. Braun Medical Inc. (US)
Location:
Irvine, California, United States
Functional Area:
Research and Development
Working Model:
Onsite
Days of Work:
Wednesday, Tuesday, Thursday, Friday, Monday
Shift:
5X8
Relocation Available:
No
Requisition ID:
10532
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 (Parui-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
Perform analytical method development, verification/validation using a wide variety of analytical techniques, such as HPLC, GC, FTIR, UV, LC/MS, GC/MS, 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 impurity identification related to drug substance, drug products, extractables/leachables.
Plan, organize, and conduct analytical experiments and research activities to support drug product development and commercialization.
Review data, notebooks, and reports to ensure compliance with specifications, standard operating procedures, and regulatory requirements.
Author pertinent protocols, reports, and relevant CMC sections for regulatory filings.
Collaborate with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques/products.
Expertise: Knowledge & Skills
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 related to extractables/leachables preferred.
Knowledge of USP, EP, FDA CFR & ICH, ISO regulations and guidelines regarding extractables/leachables and impurities.
Experience in analytical method development/optimization, validation, troubleshooting, etc.
Proficiency with Microsoft Office Applications (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 assist in orienting, training, assigning & checking the work of other peers.
Judgement required in resolving complex problems based on experience.
Required Qualifications
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 geographic differential. Compensation decisions are dependent on facts and circumstances of each case. The range provided is a reasonable estimate.
Benefits
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 at www.bbraunusa.com.
EEO Statement
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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