B. Braun

  • Mgr III Quality Chemistry

    Job Locations US-CA-Irvine
    Requisition ID
    2018-13028
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8am - 5pm
    Site
    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.

    Responsibilities

    Position Summary:

    Site Head of Quality Chemistry organization. Provide Leadership to Chemistry QC, QC in process control and Stability groups responsible for providing QC technical expertise, oversight, and testing to support new product development, regulatory submissions, sustaining projects, and release of commercial products. Manages staff of approximately 60 Chemistry Associates and 3 million dollar budget.  Site Subject Matter Expert on Chemistry and physical testing and manufacturing technologies, method and process validation, and regulatory compliance requirements for pharmaceutical manufacturing.  Provide QC technical and tactical support for the B. Braun manufacturing facilities to ensure compliance with cGMP and regulatory requirements both internally and externally.  Plan, organize and manage the activities to ensure timely completion of group's tasks.  Interact with FDA and other regulatory authorities as Subject Matter Expert for Irvine Quality Chemistry processes and procedures. Manage the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to support the company goals while complying with regulatory requirements.

     

     

    Responsibilities: Essential Duties

    • Manage and provide leadership to QC Chemistry and process control groups to support daily operation of Irvine plant.
    • Write, collect, organize, compile, and review protocols, data, and reports to comply with regulatory requirements.
    • Investigate deviations to determine the impact on the product quality, the root cause, and corrective actions to preclude further impact.  Evaluate technical problems and provide recommendation for correction actions.
    • Manage work and provide technical direction to QA labs group to ensure that products and processes meet company and regulatory requirements.
    • Provide product impact assessment in case of deviations.
    • Provide Validation and Change impact assessments.
    • Conducts hands-on experiments or work as necessary to solve problems and provides technical guidance to team members on routine and special tasks.
    • Create, review, and approve chemistry protocols, specifications, Test Methods, and SOPs. 
    • Authors, reviews and approves study protocols, reports and any other documents related to analytical methods development and validation, feasibility study, material qualifications, and technical investigations.
    • Partner with Quality to comply with USP, CFR, and other regulatory changes.
    • Follow and coordinate implementation of USP, FDA, ICH changes & updates impacting Quality, Manufacturing, and Pharm.D.
    • Coordinate and manage sustaining projects due to change in materials and processes to support manufacturing.
    • Support Pharm.D. in new products development, and other special projects.
    • Review, approve, and assist in writing the CMC sections for regulatory submissions.
    • If needed, acts as Team Leader supervising and guiding all activities associated with Methods Development, Methods Validation / verification, Formulation Development, Raw Material Qualification, and New Product Feasibility for QC chemistry group.
    • Mange analytical test methods Validation and Verification as required.
    • Direct and Manage development and commercial stability programs.
    • Support qualification of materials (filters, raw materials, processing materials, plastics, inks adhesives etc.).
    • Support qualification of contract laboratories.
    • Support purchasing group in managing material flow to manufacturing operations.
    • Create, evaluate, and approve SCANs related to chemical raw materials.
    • Direct and coordinate cleaning validation requirements.
    • Reviews and approve work, results, data, reports and any other documents generated various groups for cGMP compliance.
    • Review data trending reports for raw materials, finished products, and environmental.
    • Coordinate and monitor the annual reserve sample selection, storage, and inspections.
    • Prepare Annual Product Profile.
    • Perform and direct customer complaints (PIR) investigations.
    • Generate monthly reports.
    • Coordinate and support cGMP/PAI Inspections, internal/external audits as SME.
    • Manage departmental budget effectively by applying cost saving measures.
    • Coordinate the Quality Control operations for B. Braun in Canada with the Canadian contractor, ensuring that the Canadian regulatory requirements are met.
    • Provide Technical Support Marketing and Customer Services group.
    • LIMS Management and periodic update.
    • Periodically review the procedures and processes to remove non-value added (NVA) practices to be cost effective.
    • Provide for the professional growth of assigned staff to ensure current and complete knowledge of technical, regulatory and company requirements and of management techniques.
    • Other duties as assigned.

     

    Expertise: Knowledge & Skills

    • Basic understanding and experience with pharmaceutical products, especially injectable products (LVPs & SVPs)
    • Knowledge of chemical, physical and biological testing.
    • Strong Knowledge & Understanding of cGMP, GLP, USP, ICH & CFR / FDA requirements & guidelines, AOAC, and EP. 
    • Excellent written and verbal English skills with experiences in writing protocols, reports, and proposals.
    • Good communication and interpersonal skills.
    • Broad knowledge of scientific theories, instrumentation and statistical techniques.
    • Familiarity with eCTD submissions requirements for regulatory agencies.
    • Working knowledge and/or experience in parental solutions manufacturing.
    • Working knowledge and/or experience with Terminal Sterilization, Isolator Technology, and Aseptic processes.
    • Knowledge of Pharmaceutical Water Systems.
    • Knowledge of Analytical Instruments Qualifications/Validations.
    • Working knowledge of manufacturing and laboratory operations.
    • Experience in Cleaning Validations, Mixing Validations, and Process Validations.
    • Technical writing skills and experience with writing protocols, reports, proposals.
    • Knowledge of  LIMS, SAP, and Data management/analysis software, & Statistical data analysis .
    • Experience in operations planning, budget planning and staffing.
    • Basic understanding and experience in formulating parenteral injectables.
    • Basic understanding of manufacturing processes.
    • In-depth understanding of different technologies in chemical analyses in pharmaceutical developments, such as: wet chemistry, MS, HPLC, GC, MS, FT-IR, UV-VIS, Polarimetry, AA and of general laboratory techniques and practices.
    • Proven good organizational/leadership skills.
    • Highly energetic, people oriented individual with the ability to develop and motivate subordinates.
    • Good organizational, management, team and coordination skills with the ability to promote and adapt to changes.
    • Must be able to independently operate, analyze information, and make quality decisions under pressure.
    • Ability to make verbal presentations to small or large groups at all levels, both inside and outside of the company.
    • Proven QC Laboratory Management and Quality Systems Experience.
    • Proficient in the use of a wide variety of word processing and spreadsheet software packages.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • BS/BA degree in chemistry or scientific discipline, with 10 years’ experience in pharmaceutical industry or MS/MA or Ph.D. degree in chemistry or scientific discipline, with 5 years’ experience in pharmaceutical industry.

    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.

    Other

    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.

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