B. Braun

Research Associate I

Job Locations US-CA-Irvine
Requisition ID
2021-19572
Company
B. Braun Medical Inc
# of Openings
1
Category
Other
Position Type
Regular Full-Time
Shift
M-F; 8am - 5pm
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 64,000 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 associate position is with the B. Braun Pharmaceutical Research & Development department. The incumbent will be involved in drug product activities related analytical method development, optimization, validation and testing 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

  • Support planning and research and lab operation activities.
  • Apply scientific principles to the product development and product release processes.
  • Gathers, processes, and analyzes results and data.
  • Builds and tests new designs, formulations, materials, or systems for compliance with quality and/or performance standards.
  • Recommends changes to production processes or materials used.
  • Perform analytical method development, verification, validation and testing using a wide variety of analytical techniques, such as HPLC. GC, FTIR, UV, etc.
  • Conduct Extractables/Leachables studies for IV container closure materials such as resin, plastic film, stoppers, inks, adhesives, etc. 
  • Independently set up and operate analytical instrumentations and perform troubleshooting as needed.
  • 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 drug products in compliance with quality and/or performance standards/specifications.
  • Review data, notebooks, and reports to ensure compliance with specifications, standard operating procedure, and regulatory requirements
  • Author pertinent protocols, reports, and relevant CMC sections for regulatory filings.
  • 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

  • Requires basic knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles, concepts and integrates them to propose 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.
  • Good communication (written and verbal), attention to detail and organizational skills
  • Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task.
  • Some degree of judgment required in resolving problems based on experience.
  • Contacts are primarily with direct supervisor, peers and subordinates.
  • Hands-on experience in analytical and physical characterization technologies, including HPLC, GC, UV, FTIR and other complex analytical techniques is required. 
  • Experience in analytical method development/validation, troubleshooting, optimization and transfer to QC.
  • Requires working knowledge of professional field and pharmaceutical industry in cGMP and/or R&D environment.
  • Proficiency with Microsoft Office Applications (e.g. Word, Excel, Power Point).
  • Working knowledge of chromatography data systems (e. g. Empower) is highly preferred.
  • 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 as demonstrated in writing project proposals, protocols and reports.
  • Scientific contribution skills as demonstrated by posters, presentations, patents or presentations.

Preferred Requirements:

  • Pharmaceutical experience.

 

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • Bachelor’s degree in related science or equivalent combination of education and experience required
  • 2-4 years related experience

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.

 

 

Additional Information

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

What We Offer

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.

Notices

Equal Opportunity Employer Veterans/Disabled

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