B. Braun

  • Sr Research Scientist I

    Job Locations US-CA-Irvine
    Requisition ID
    B. Braun Medical Inc
    # of Openings
    Position Type
    Regular Full-Time
    8:00am- 5:00pm
    Irvine, CA
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.


    U.S. Facilities and Operations:


    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.


    Position Summary:

    This is a scientific role within the R&D Pharmaceutical Chemistry group with focus on material science and analytical chemistry – includes polymer material qualifications, extractables-leachables, and development of pharmaceutical IV drugs and combination product platforms.  The incumbent shall provide relevant subject matter expertise in material science (pharmaceutical grade resins, polymeric films, adhesives, inks), organic chemistry, and analytical chemistry to design, conduct, and manage research studies on container-closure materials selection, qualification, stability evaluation, physical-chemical and bio-compatibility, extractables and leachables studies, and safety evaluation to support Pharmaceutical R&D injectable drugs and solutions portfolio from the innovation phase to commercial product realization (Para I-IV ANDA, PAS, 505b(1)/(2) NDA categories). 


    Responsibilities: Essential Duties

    • Perform polymer characterization with general techniques such as viscometry, FITR, Thermal analysis (differential Scanning calorimetry (DSC), thermogravimetric analysis (TGA), etc. to guide material selection during early and late stage product development and life cycle management activities.
    • Perform a wide variety of analytical tests by using HPLC/PDA/UV/MS, GC/FID/MS, and other analytical methods.  Design and author specifications for material release and transfer test method to QC and manufacturing sites.
    • Plan and coordinate with contract Labs and CROs for material qualification and biocompatibility studies as needed.  Collaborate with internal and external cross functional teams for container closure system development throughout product development cycle.
    • Design and conduct material physical-chemical, stability evaluation and compatibility studies per USP, ICH and regulatory requirements.  Evaluate, design and conduct analytical method development, verification and validation activities.  Review data and reports to ensure compliance with specifications, standard operation procedures, and regulatory requirements.
    • Design and conduct extractables/leachables studies for container closure materials for parenteral drug products.  Author protocols and technical reports.  Prepare summary reports and presentations for review by senior management, and in support of regulatory interface meetings and FDA submissions.
    • Independently set up and operate analytical instrumentations.  Perform troubleshooting as needed.  Evaluate novel analytical chemistry technologies to advance scientific knowledge and to improve work-flow efficiency.
    • Continue to develop expertise in areas related to polymer science, analytical chemistry and container material evaluation to line up with regulatory requirements.  Publications in peer review journals and presentation at internal/external scientific forums is highly encouraged.

    Expertise: Knowledge & Skills

    • Proven technical problem solving skills.
    • Working knowledge of chromatography data systems (e.g. Empower, ChemStation) is preferred.
    • Broad understanding of the FDA guidelines, cGMPs and GLPs, ICH.
    • Strong verbal and written communication skills.
    • Demonstrated ability to effectively interact with cross-functional teams.
    • Scientific contribution skills as demonstrated by posters, presentations, patents or presentations.


    Expertise: Qualifications - Experience/Training/Education/Etc



    • A Ph.D. or M.S. degree in polymer science, material science, organic chemistry, analytical chemistry, pharmaceutical chemistry or a related discipline.
    • Pharmaceutical Industry or a directly relevant post-doc experience, of 4-8 years for Ph.D. and 6-10 years for M.S. candidates.
    • Must have strong fundamental understanding of principles related to extractables and leachables, polymer science, chemical and physical properties of polymer materials, engineering applications and structure-property relationships (e.g. plastic, elastomer, adhesive, inks).
    • Must have strong background and hands-on experience in polymer characterization techniques such as viscometry, FTIR, thermal analysis (differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and dynamic mechanical analysis (DMA), nuclear magnetic resonance (NMR), and rheology.
    • Must have hands-on expertise in analytical technologies, including HPLC, GC, UV, FTIR, MS, DSC, TGA and related techniques. 
    • Fundamental understanding of chemical reaction mechanisms, chemical kinetics and drug-material interaction and degradation pathways.



    • Experience of polymer characterization with USP<661.1>, <661.2>, <381>, <87>, <88>, ISO-10993 evaluation for materials used for pharmaceutical and medical device is highly desirable.



    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 20 pounds.



    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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled


    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.


    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.


    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. The noise level in the work environment is usually moderate.


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