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.
Site Info: The Pharma R&D team is located at B. Braun Medical’s US Pharma plant site located in Irvine, CA. The R&D team has approximately 40 fulltime associates developing products for multiple manufacturing locations. The plant location in Irvine employs 2K people, manufacturing sterile liquid parenteral and injectable drug products in high volume production of 200 Million IV bags per year.
This Senior Director will report to the Corporate VP of R&D based in PA, This role will have 4-5 direct-reports; senior technical scientists (PhD, Masters level), their associates, and the container Development Engineering department reporting to it, in Irvine, CA
This Pharma R&D group is responsible for innovation pipeline development and development through product realization of new Pharma products to expand the current product offerings and company market share, for variation in product doses, strengths, methods, etc. This role requires scientific work for the sake of guiding proof of principle and feasibility, final formulation and packaging, analytical testing, stability testing, and submission documentation of new or revised drug products and packaging. The efforts will abide by the prevailing industry standards such as ICH, cGMP, 510(k), and internal Quality Systems.
This is a leadership role requiring a blend of technical and business skills (50% technical – 50% business) to work closely with R&D, Marketing, Medical Affairs, Regulatory affairs, Quality, Manufacturing, customers, etc.
The right person will be responsible to oversee the innovation team, formulation chemistry development, analytical development, and packaging development. Together with Marketing, this person will prepare business cases for improved profitability and prioritize selection of programs to execute and accelerate our injectable drug pipeline.
The preferred job location is Irvine, CA where the reporting team members are based. As an Alternative the East Coast HQ site of Bethlehem, PA will be considered too. This role has the flexibility to Work from Home for 2 days a week, after some time and management approval. This job will also require some global travel as we partner with our global marketing, R&D, and other development partners within our network.
If located on the East Coast this position will require travel one week per month to Irvine, CA to meet the team and 2 times per year to attend future FDA meetings, technical conferences, symposiums and meet other company professionals as needed. Some global travel will also be required.
Responsibilities: Essential Duties
Expertise: Knowledge & Skills
Through vision, collaboration, and cross-functional employee engagement, this role will foster creative and accountable application of professional knowledge, skills, and experience in the development of a pipeline of next generation Pharma-related opportunities that fulfil the strategic goals of the organization.Judgement is required in resolving complex problems based on experience.
Candidate Must Have:
Expertise: Qualifications -Education/Experience/Training/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 20 pounds.
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.
While performing the duties of this job, the employee is expected to:
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.
Equal Opportunity Employer Veterans/Disabled