B. Braun

  • Research Scientist II- Pharmaceutical Product Life Cycle Management, R&D

    Job Locations US-CA-Irvine
    Requisition ID
    2019-14214
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Other
    Position Type
    Regular Full-Time
    Shift
    Monday - Friday Days
    Site
    Irvine, CA
  • 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 is a technical role within the B. Braun Pharmaceutical Research & Development department.  The incumbent shall be engaged in Product Life Cycle Management (LCM) & Regulatory Compliance related laboratory activities with Analytical Chemistry focus. 

     

    A degree in Analytical Chemistry, Organic Chemistry, or a related discipline, and a Pharmaceutical Industry experience is required.  Experience with large-small volume parenterals & sterile products and/or product life cycle management is desired.  The candidate must be able to provide subject matter expertise in interpreting the FDA, ICH, EMA and related regulations, work with cross-functional teams, develop strategies, and implement research studies to meet product LCM management objectives.  Must have strong verbal communication and expert technical writing skills as demonstrated by technical posters, presentations and manuscripts.  Hands-on expertise in Analytical Technologies, including HPLC, GC, UV, FTIR, MS, and related techniques.  Expertise in defining and analytical target profiles (ATP), developing a control strategy, qualifying methods and monitoring method compliance with evolving regulatory standards.  Working knowledge of analytical data systems (e.g. Empower, ChemStation), and familiarity with FDA regulatory pathways (PAS, CBE) is desired. 

     

    The incumbent will be engaged in LCM activities that include:  Conduct verification / validation of analytical methods and test procedures in compliance with emerging USP/FDA / EMA / ICH guidelines.  Conduct technical investigation, gap analysis, risk assessment and confirm suitability in situations involving API &material Vendors / DMF / Process changes.  Provide technical inputs, design & implement laboratory studies, and prepare technical justification reports for Raw Material (API, excipients, container materials such as resin, inks adhesives, etc.) Testing and Control plans.  Review and track Registration stability and Annual stability testing data for deviations and trends.  Serve as a subject matter expert for internal and USP initiatives related to API and product Monograph authoring and revisions.  Design analytical target profiles (ATP), develop control strategies, method qualifications and proactive monitoring of method performance.  Provide technical inputs and implement studies required for product, process and material changes (PAS, CBE-0, CBE-30).  Serve in SME capacity for material specification justification, setting, monitoring and harmonization.  Serve as coordinator with contract lab, CROs, and consults to conduct tests, safety/toxicological assessment, compliance evaluations.  Review and author the Analytical & related CMC sections for regulatory submissions & correspondence.

     

    Responsibilities: Essential Duties

    • Plans, organizes, and conducts experiments and research activities.
    • Builds and tests new designs, formulations, materials, or systems for compliance with quality and/or performance standards\
    • Processes and analyzes results and data.
    • Applies the results of research and develops new techniques.
    • Collaborates with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques.
    • May provide guidance to and/or oversee the work of lower level associates and scientists.

     

    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

    • Requires full working knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, and concepts. Determines best course of action.
    • Knowledge of USP, EP, cGMP/GLP, FDA CFR & ICH regulations and guidelines.
    • Working knowledge of chemical theories, concepts, test methods and instrumental methods.
    • Analytical and research skills
    • Strong communication (written and verbal), attention to detail and organizational skills
    • Works 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 lower level employees. Referring only complex problems and issues for superiors review or approval.
    • Judgement is required in resolving complex problems based on experience.
    • Contacts are primarily with direct supervisor, peers and subordinates.

     

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Master's degree related science required, PhD preferred
    • 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.

     

     

    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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! Click here to get started.