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.
This is a senior level technical role within the B. Braun Pharmaceutical Research & Development department. The incumbent shall be engaged in Product Life Cycle Management (PLCM) activities with focus on Injectable Formulations & Containers Chemistry.
Responsibilities: Essential Duties
Lead and coordinate high impact PLCM activities for development of next generation product platforms for B. Braun Pharmaceutical therapeutic drugs and infusion fluids business segment, in addition to maintenance of current commercial products in compliance with USP / FDA / ICH and related regulatory expectations.
Design laboratory studies, and prepare technical justification reports for material selection, deployment and control plans (alternate API, excipients, IV container closure materials such as resin, stoppers, inks, adhesives, etc.).
Lead technical investigations and risk assessments for product, materials and process changes (e.g. supplier or DMF changes) and collaborate in development of regulatory strategies and authoring CMC related documents (PAS, CBE-0, CBE-30).
Provide SME inputs for material specification justification, setting, monitoring and harmonization.
Build networks with contract labs and CRO’s to conduct analytical testing, safety-toxicological assessment, biocompatibility studies, and compliance evaluations.
Lead internal and USP initiatives related to API and Product Monograph authoring and revisions.
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
A Ph.D. degree in Analytical Chemistry, Organic Chemistry, Toxicology, Pharmaceutics, or a related discipline is required. Pharmaceutical Industry (or combination of industry + post graduate research experience) of 12-15 years in one or more areas related to sterile products development, product life cycle management (chemistry), material biocompatibility, toxicology, and extractable-leachables (stoppers, polymeric resins, labeling material, containers) is desired.
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 PLCM management objectives.
Hands-on expertise in Analytical Technologies, including HPLC, GC, UV, FTIR, MS, NMR and complex analytical instruments is required.
Must have strong verbal communication and expert technical writing skills as demonstrated by technical posters, presentations and manuscripts.
Contacts are primarily with direct supervisor, peers and subordinates.
Expertise: Qualifications - Experience/Training/Education/Etc
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.
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.
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.
Lifting, Carrying, Pushing, Pulling and Reaching:
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.