Sr Manager, MDCP- External Supply Support
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
As a member of the Pfizer team, your role will be accountable for activities involved in the design and development support of manufacturing processes for medical devices and combination products (MDCP), taking into consideration problems inherent in the transfer of technology from research to manufacturing. Such design and development may include new or revised processes. Your work will help develop procedures for the economical mass production in cooperation with R&D, Pfizer plants and Contract Manufacturers. You and your team will oversee tests, measurements and data analysis throughout stages of development and production to assure robust design, transfer and production of MDCP products:
- Technical expert responsible for Medical Device and Combination Product (MDCP) Device Engineering
- Responsibilities includes New Product Development/Co-Development, on-market product and process change management execution and oversight, and risk management for MDCP’s manufactured by External Supply partners
- Additional responsibilities include identification, evaluation and leadership of execution of value-driven innovation opportunities, i.e. cost-reduction, quality improvement and/or sustainability improvement
- Scope of role is focused on Global Medical Devices and Combination Products manufactured by Contract Manufacturers (External Supply or ES) on behalf of Pfizer, and may include support of PGS sites as needed
- Center-function role with cross-functional interfaces, including Pfizer Global Supply (PGS) External Supply Operations, Quality and Global Technology & Engineering Device Engineering
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your experience in project management will be used while reviewing status of projects and budgets, managing schedules and preparing status reports, developing resolutions to meet productivity, quality and client-satisfaction goals. Your ability to develop and manage plans will facilitate achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
It is your dedication that will make it possible forcustomers and patients to receive the medicines they need, when they need them.
How You Will Achieve It
- Lead development and execution of strategy to assure robust operations engineering support for MDCP’s in External Supply
- Use domain expertise and Project Management skills to lead moderately to highly complex projects, including on-market product enhancements, value-driven innovation and sustainability improvements
- Coach, guide and influence Contract Manufacturers (CMOs) in effective management of MDCP’s with respect to industry best practices, e.g. Design & Development, device manufacturing Process Validation and Risk Management
- Assure execution of robust design change management as related to External Supply manufacturing & supply-chain considerations, including leading coordination across functional teams and 3rd parties where needed
- Identify opportunities for design or process improvements focused on Quality Improvement, carbon-footprint or waste reduction, and COGS improvement
- Lead CMO assessment and selection process in early stage product development
- Execute CMO root-cause analysis and troubleshooting for supply-continuity issues related to MDCP components/products/manufacturing processes
- Provide technical leadership for MDCP DHF activities as needed
- May manage contingent workers through a matrix organization
- Participate in investigations of customer complaints related to MDCP’s for complaints that may be design-related, coordinating with CMO’s and External Supply Quality as applicable
- Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation process
- Collaborates with External Supply Operations and Quality colleagues on product and process change management and risk management activities for product lifecycle
- Represent device engineering on change / CAPA review board as needed
- Ensure site readiness for new product introduction and launch at CMO
- Identify Continuous Opportunities in business processes and be a change agent to ensure agility and embed Lightspeed principles.
- Bachelor’s Degreein Engineering, Science or related technical discipline and8+ years of relevant pharmaceutical experience.
- Strong interpersonal skills with the ability to work independently, as a leader or member of a team and in collaboration with other functional groups
- Strong technical knowledge of complex Medical Device and/or Combination Products technologies
- Ability to advance new processes and moderately to highly complex methodologies
- Leverages excellent interpersonal and communications skills to review, discuss, and inform key stakeholders of concepts to drive informed decisions
- Develops innovative solutions to complex problems impacting the Businesses
- Effective written and verbal communication skills.
- Independent,self-motivatedand flexible with the ability to work effectively in a dynamic, problem-solving environment.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Master’s degreeand10+ years ofrelevant pharmaceutical experience.
- Experience with supplier/vendor-management
- Experience in problem-solving, negotiations,presentationand supervision of amulti-layered organization, including understanding of DMAIC (six sigma) tools and practices and a focus on continuous improvement.
- Note: Hiring Manger to update the methods and tools based on requirements.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some travel may be expected as part of this role (<20%)
ADDITIONAL POSITION DETAILS
Last Date to apply - July 7, 2022
Work Location Assignment:Can be globally remote
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Engineering