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Research Scientist II

Company: B. Braun Medical Inc.
Location: Irvine
Posted on: June 6, 2021

Job Description:

Overview

About B. Braun

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 61,000 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.

Responsibilities

Position Summary:

This Research Scientist II position is part of the B. Braun Pharmaceutical Research & Development department. The incumbent shall provide relevant subject matter expertise in analytical method development, optimization and validation to support Pharmaceutical R&D portfolio from the innovation phase to commercial product realization (Para I-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.

Responsibilities: Essential Duties

  • Evaluate, design and conduct analytical method development to support from early to late stage pharmaceutical product development.
  • Conduct Extractables/Leachables studies for IV container closure materials such as resin, plastic films, stoppers, inks, adhesives, etc.
  • Independently set up and operate analytical instrumentations. Perform troubleshooting as needed.
  • Conduct and support chemical impurity/degradant identification and characterization to support regulatory filings.
  • Determine chemical degradation mechanisms, structure elucidations and provide hypothesis on possible degradation and/or interaction pathways of active ingredient(s) in drug product formulations.
  • Review works, results, data, reports and any other documents generated by peer staff to ensure compliance with current GMP/GLP regulations, specifications, standard operating procedures, and regulatory requirements.
  • Prepare summary reports and presentations for review by senior management, and in support of regulatory filings.
  • Author pertinent protocols, reports, and relevant CMC sections for regulatory filings.
  • Continue to develop expertise in areas related to analytical method development, structure elucidation and drug degradation pathway determination.
  • Publishes research papers in peer review journals and presents at internal/external scientific forums.
  • Plans, organizes, and conducts analytical experiments and research activities to support drug product development and commercialization.
  • Supports analytical testing of new container closure systems, formulations, materials, drug substance and products in compliance with quality and/or performance standards/specifications. Processes, and analyzes analytical test results and data.
  • Prepare necessary documentations to support regulatory submissions.
  • Collaborates with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques/products.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

  • Hands-on expertise in analytical and physical characterization technologies, including HPLC, GC, UV, FTIR, MS, TGA, DSC and other complex analytical techniques is required.
  • Expertise in chemical impurity/degradant identification and characterization to establish drug degradation pathways.
  • Expertise in analytical method development/validation, troubleshooting, optimization and transfer to QC.
  • Expertise in experimental designs for extractables/leachables study and evaluation of impurities.
  • 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.
  • Broad understanding and knowledge of USP, EP, cGMP/GLP, FDA CFR & ICH regulations and guidelines.
  • Understanding of the pharmaceutical development process and regulatory workflows (IND, ANDA, NDA etc.) with focus on injectable drugs or combination products.
  • Strong communication (written and verbal), attention to detail and organizational skills as demonstrated in writing project proposals, protocols and reports.
  • Scientific contribution skills as demonstrated by posters, presentations, patents or presentations.
  • This list is however not exhaustive and may be amended by the Management from time to time.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning and checking the work of lower level employees. Escalating only complex problems and issues.
  • Experience working in a Pharmaceutical environment preferred.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • PhD required or equivalent combination of Master's degree and directly relevant experience and certifications.
  • 8-10 years related experience
  • Applicable industry certification preferred

Desired:

  • N/A

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 40 pounds.

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.

Other

Responsibilities: Other Duties

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Strength:

  • Moderate work - Exerting up to 40 lbs. of force occasionally, and/or up to a negligible amount of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

  • Occasionally: Reaching upward and downward, Push/pull,
  • Frequently: Standing, Sitting, Visual Acuity with or without corrective lenses
  • Constantly: N/A

Activities:

  • Occasionally: Reaching upward and downward, Push/pull, Walking, Talking
  • Frequently: Standing, Sitting, Visual Acuity with or without corrective lenses, Hearing
  • Constantly: N/A

Environmental Conditions:

  • Occasionally: Work with chemicals in laboratory environment and wear personal protective equipment
  • Frequently: N/A
  • Constantly: N/A

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Noise Intensity: Moderate
  • Occasionally: Production/manufacturing environment
  • Frequently: N/A
  • Constantly: Lab environment

Notices

Equal Opportunity Employer Veterans/Disabled

Keywords: B. Braun Medical Inc., Irvine , Research Scientist II, Other , Irvine, California

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