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:
The Sr. Project Manager (PM), Project Management Office (PMO) will lead the planning and execution of diverse, challenging projects and departmental assignments supporting the USA market. For example (but not limited to), the Sr. PM may be called upon to:
- Lead or support R&D New Product Development projects, primarily focused on IV and irrigation solutions.
- Lead or support strategic, multi-million dollar Operations projects or programs, such as internal manufacturing (capital equipment and facility) scale-up projects for new products, and capacity expansion projects for existing products, as well as contract manufacturing organization (CMO) scale-up projects.
- Lead or support the development, execution and continuous improvement of PMO standard work processes, including: Capital Stage-Gate process, New Product Development Phase-Gate process, and the PXC/PMB project portfolio management process. Conduct PMO training sessions for these processes, for both pharmaceutical and medical device project leaders across multiple sites. Lead internal PM Discussion Forums.
- Manage and/or mentor less experienced PM staff members.
The Sr. PM may manage global cross-functional team resources throughout the project life cycle, and is accountable for meeting the agreed upon goals of the project, including the project schedule and budget, as well as the quality (e.g., scope and performance) of the project deliverables.
The Sr. PM should have skills and experience in using world class project management principles (e.g. PMI PMBOK), as well as knowledge and practical experience with relevant industry technical guidelines (e.g., FDA cGMP, Chemistry and Manufacturing Controls (CMC), GCP, ICH, ISPE GAMP® 5 and Good Practice Guides, and ISO standards). Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Partner with global cross-functional team members, equipment designers/builders, architectural and engineering firms, and other internal and external stakeholders as necessary to prepare business cases for proposed new product development projects and capital projects.
- Lead or provide tactical guidance for the planning and execution of new product development projects from the Development phase through commercialization. This includes responsibilities for facilities, equipment, supply chain, CROs, CMOs and other outside services, staffing, operating procedures, policies and standards.
- Manage project team resources to achieve the agreed upon goals of the project, including the project schedule, project budget and project quality (e.g., scope and performance) for the new drug product that will be commercialized, or the capital equipment and facility that will be deployed for commercial manufacturing.
- Collaborate with the Project Sponsor, Project Steering Committee, Functional Manufacturing Leaders, Technical Services, Marketing, Finance, Regulatory Affairs, Medical Affairs, Clinical Affairs, Quality Assurance, Legal, Strategic Purchasing, Local Purchasing, Planning and Warehousing staffs, Customer Service, Business Systems and other stakeholders to ensure the seamless phase-in of new products, equipment, processes and facilities.
- Ensure the effective use of human, physical and financial resources in order to achieve company objectives.
- Evaluate team member performance.
- Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve the project management processes to achieve product quality, customer satisfaction, product cost goals, and other key performance indicators.
- Monitor and confirm organizational adherence to policies, procedures, regulations and standard work.
- Responsible and accountable for justification, hiring, development, salary administration and performance evaluation of any assigned employees or proposed new positions.
- Communicate effectively to all levels of the organization using all forms of communication.
- Drives effective and timely problem solving through the use of team resources and Lean/Quality tools (e.g., DMAIC).
- Responsible for developing, monitoring and achieving any assigned budgetary goals.
- Create and deliver presentations to all levels of the organization regarding project timing, cost, risks and quality.
- Conduct periodic reviews with the project team and with management to ensure that phase-gate or stage-gate transition criteria are met in the most efficient manner.
- Cultivate a positive team spirit and a healthy team dynamic. Ensure that the team develops and maintains a common mission and vision of success throughout the project life cycle.
- Demonstrated Project Management knowledge of tools, techniques, culture and software applications (such as Microsoft Project).
- Quality Systems, cGMPs.
- Product development and sustaining knowledge, manufacturing process knowledge, CMO knowledge, and Capital equipment and facility knowledge, are highly desired.
- Experience with manufacturing terminally sterilized products, and aseptic manufacturing technologies.
- Must be able to communicate (face to face, team meetings, provide presentations, and train employees) with every level of the company, as well as with customers and suppliers. Must have good team building skills and must be able to lead cross functional / international teams.
- Demonstrated success in leading project teams and managing projects from initiation through completion.
- Skilled with project management software such as MS Project.
Qualifications: Expertise: Qualifications - Experience/Training/Education/Etc Required
- BA/BS degree in Engineering, Science or other relevant area of study, plus a minimum of 7 years related experience in forms of Project Management. Must have experience in either the Pharmaceutical or Medical Device industry.
- Domestic and international business travel up to 50% may be required, depending on the assigned projects.
- Valid driver's license, passport.
- PMI PMP certification. Experience in managing Capital equipment and facility projects, and/or drug development projects, is highly desired and preferred for this position.
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.
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.
Other: Responsibilities: Other Duties:
- Other duties as assigned.
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. 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. The noise level in the work environment is usually moderate. #LI-CB1
One of the world's leading healthcare suppliers.