B. Braun

  • Research Scientist II

    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 Pharmaceutical R&D Product Innovation group.  The incumbent shall provide relevant subject matter expertise in formulations, physical pharmacy, pharmaceutical chemistry and drug delivery to conceptualize and demonstrate feasibility of new products & platforms; and be directly involved in expanding the R&D pipeline (Para I-IV ANDA, PAS, 505b(1)/(2) NDA categories).  B. Braun Pharmaceutical portfolio includes sterile infusion fluids, premixed RTU therapeutic drug solutions, DuplexTM dual chamber products, and Nutrition therapy products.



    Responsibilities: Essential Duties

    • Develop product concepts based on technical, patent, market, customer and clinical research. 
    • Design and conduct laboratory studies to test feasibility of new product concepts.
    • Manage internal and external interfaces related to research, product prototyping and testing.
    • Conduct intellectual property research by reviewing patents, litigations and petitions pertaining to innovator and generic product opportunities that fit B. Braun pipeline strategy.
    • Identify and recommend external resources and partners to extend R&D product innovation and development capabilities.
    • Engage in and provide technical support to internal as well as externally partnered (OEM) / cross-divisional projects.
    • Interface with cross-functional departments, including Marketing, Regulatory Affairs, Purchasing, and Clinical to identify and align on new product portfolio, platform and strategy.
    • Author, review and approve product concept papers, reports and technical investigations.
    • Perform formulation and analytical chemistry testing and document reviews as needed.
    • Develop new analytical and physicochemical testing methods as needed.
    • Elucidate chemical reaction mechanisms and structures and provide hypothesis on possible degradation and/or interaction pathways of active ingredient(s) in drug product formulations.
    • Conduct necessary product performance and stability studies and DOE’s to demonstrate developability of new products and concepts.
    • Review works, results, data, reports and any other documents generated by peer staff for compliance to current GLP, GMP and Documentation requirements.
    • Assist in writing pertinent CMC sections for regulatory submissions and in interactions with FDA and other regulatory agencies.
    • Serve as a technical expert and represent R&D at internal and external Innovation, R&D and related forums.
    • Reviews or develops specifications for new components and products.  Evaluate suitability with manufacturing components and equipment train.


    Expertise: Knowledge & Skills

    • Thorough understanding of the pharmaceutical development processes and regulatory workflows (IND, ANDA, NDA), with focus on generic injectable drugs, differentiated products or combination products.
    • Proven technical problem solving skills.
    • Demonstrated experience in writing project proposals, protocols and reports.
    • Demonstrated ability to effectively interact with cross-functional teams.
    • Broad understanding of the FDA guidelines, cGMPs, and GLPs, ICH.
    • Knowledge of statistics and DOE’s in preferred.
    • Strong verbal and written communication skills. 
    • 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 pharmaceutics, pharmaceutical chemistry, analytical chemistry, industrial pharmacy, organic chemistry or related scientific discipline. 
    • Pharmaceutical Industry or a relevant post-doc experience of 0-5 years for Ph.D., 3-8 years for M.S. candidates.
    • Must have strong hands-on technical expertise in design and development of pharmaceutical formulations, preferably injectable drugs or drug delivery systems.
    • In depth understanding of pharmaceutical product manufacturing processes, preferably injectable drug manufacturing. 
    • Must have demonstrated experience and subject matter expertise in one of more of the role relevant areas: formulation development, drug delivery, combination products, preformulation, reaction mechanisms / organic chemistry, analytical chemistry, pharmaceutics and material science.
    • Must have hands-on expertise in analytical and physical characterization technologies, including HPLC, GC, UV, FTIR, MS, DSC, TGA, viscometry, KF, and related techniques.



    • 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 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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