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.

 

Position Summary:

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.

 

Group Info:

 

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.

 

Job Summary

 

• Under the direction of the Corporate VP, R&D, the Senior Director of Pharmaceutical Development will engage a cross-functional team in activities that bring new Pharmaceutical chemistry and packaging products through their development and change lifecycle: from user-needs identification and ideation of creative product concepts to full development, submission, and transfer of products that are safe and effective. These products are intended for impactful use by patients and care-givers while also meeting strategic business opportunities.

• The role includes responsibility for competitive product evaluation as well as scientific and data measures that support internal Pharmaceutical and combination drug/device product pipeline generation and decision-making.

• Represents the organization as a prime contact concerning competitive monitoring, innovation sensing, business planning together with Marketing, and pipeline selection of new assets and prioritization of resources..

• Interacts with senior internal and external personnel on issues often requiring coordination across the organization’s functional lines.

 

Responsibilities: Essential Duties

• Engage a cross-functional team in activities that bring new Pharmaceutical chemistry and packaging products through their development and change lifecycle: from user-needs identification and ideation of creative product concepts to full development, submission, and transfer of products that are safe and effective.
• These products are intended for impactful use by patients and care-givers while also meeting strategic business opportunities.  
• Responsible for competitive product evaluation as well as scientific and data measures that support internal Pharmaceutical and combination drug/device product pipeline generation and decision-making.
• Represents the organization as a prime contact concerning competitive monitoring, innovation sensing, business planning together with Marketing, and pipeline selection of new assets and prioritization of resources..  
• Interacts with senior internal and external personnel on issues often requiring coordination across the organization’s functional lines.

Expertise: Knowledge & Skills

• Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
• Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees. Determines actual organizational structure and allocation of resources.
• Researches new and evolving technology applications or new idea submissions for development of new and revised packaging, injectable drugs, base solutions, and combination drug-device products.
• Drives development of advanced technologies, principles and processes.
• Manages activities of a functional area which has at least 3 departments (Innovation, Development Chemistry, Packaging) or major functions through Associate Directors, managers and/or experienced employees.
• Responsible for cost, method, and employee results.
• Judgement is required in resolving complex problems based on experience.
• Represents the organization as a prime contact on projects and departmental operations.
• Interacts with senior internal and external personnel on issues often requiring coordination across functional lines.Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

   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:

 

• Master’s in Technical or Engineering or relevant field.
• 15+ years of Technical experience in BioPharma or Medical Device Industry.      
• 10+ years of experience in the Pharmaceutical industry
• 2+ years of Innovation, New Product Introduction, pipeline of product development.
• 3+ years of Technical Management experience using professional soft skills.
• cGMP experience in FDA regulated industry like Pharmaceutical or Medical device.

• Experience in 505b2 Regulatory pathways.
• Relevant practical experience and expertise in Injectable Drug development and analytical methods.

• Project Management skills and experience, creating a team environment, regular and predictable attendance
• Occasional business travel within the US and Internationally, secrecy and invention agreement and non-compete agreements are required.
• Excellent leadership, business and computer skills. 

Desired Skills

• PhD in Analytical Sciences (Chemistry, Physics) or Pharma fields of study.
• Applicable Professional Certifications and Licenses.
• Sterile aseptic injectable liquid Manufacturing/Development experience.
• Good understanding of Generic Oncology, Antibiotics, Biosimilars, Analgesics etc.
• Combination Pharma/Med Device product experience.

 

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

• Bachelor's degree required, Master's degree preferred.
• 10-15 years related experience, plus a minimum of 5 years management experience required.
• Regular and predictable attendance
• Occasional business travel required

 

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.

 

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds 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, Stand
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:N/A
• 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, Other
• Frequently:N/A
• Constantly:Office environment

 

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.

Equal Opportunity Employer Veterans/Disabled