Overview The Technical Project Manager II (TPMII) role at Repligen, in the Process Analytics business unit, is a key role with visibility to stakeholders and management throughout the organization and is commissioned as a project leader responsible for managing and supporting new product development and introduction projects. While the TPMII reports into the R&D organization, the TPMII will work closely with a cross-functional project core team to develop a project plan incorporating all required deliverables and stakeholder requirements to ensure design, quality, regulatory, and validation requirements are met for the product over the course of the project. Through the course of the project, the TPMII ensures the project plan is clear, followed, issues and exceptions are documented and escalated appropriately, and that timelines and budgets stay on track for what has been stakeholder approved. While Manager appears in the title, the TPM also fills the roles of consultant, educator, doer, scribe, advisor, challenger, expediter, advocate, spokesperson, technical liaison and more all in the service of the project, roles that all embody the fundamental ownership that is critical to success in the position. In addition to project leader, the TPMII should have an eye to continuous improvement, leveraging retrospectives during and after project completion to capture and report lessons learned, recommend process improvements, and own completion of high priority process improvements. The TPMII will also remain available for consultative support throughout the product lifecycle including post-release, phase out and obsolescence, through involvement on ECN completions and continuous improvement tracking, though direct involvement and responsibility for the product may cease. The Process Analytics business unit specializes in instrumentation for biopharmaceutical process development and manufacturing scale customers. Historically, instrumentation has been built around UV-based absorbance spectroscopy technology. Our products range from complex systems with hardware, firmware and software, to system consumables and accessories. Responsibilities
- Manage product development and lifecycle program from project assignment through product launch and project close, with consultative support throughout production and end-of life activities.
- Gather and coalesce project teams in coordination with functional managers; generate team alignment and understanding of project objectives as well as deliverable ownership and roles and responsibilities.
- Develop project plans with the project team and assign tasks, deliverables, and deadlines to team members.
- Specify and recommend additional resource investments to fill resource gaps or reduce time to release for new products and projects.
- Manage project schedules, budgets and resources to ensure timely delivery of projects.
- Lead the project team through the product development process from product concept to product launch and post launch support activities.
- Monitor project progression, maintain project progress visibility to upper management and project stakeholders.
- Identify risks and roadblocks to completion, work with the project team to remove roadblocks and mitigate risks.
- Escalate project risks and issues as necessary to drive resolution.
- Ensure stakeholder alignment and approvals during critical stage transitions of project lifecycle.
- Oversee key project decisions to ensure alignment with delivery dates and product requirements.
- Specify and recommend additional resource investments to reduce time to release for new products and projects.
- Maintain project information and metrics of performance for product development, release and obsolescence processes.
- Identify areas for process improvements throughout the project, including at stage close checkpoints, deliverable completions, and at the end of a project.
- Drive completion of project deliverables by due dates, coordinating with deliverable owners
- Aid in identifying and solving technical challenges on current projects.
- Identify and mitigate risks throughout program execution.
- Maintain timely project information and report progress to upper management and project stakeholders.
- Complete responsibilities with minimal supervision and coaching
Qualifications
- Bachelor's degree in physical Engineering discipline
- PMP certification
- Proven track record through 5+ years in project management with new product development and launch projects
- Experience and proficiency with project management software, such as Smartsheet or Microsoft Project
- Leadership and team management, with experience motivating and guiding cross-functional teams of medium size (10-15 people)
- Demonstrated ability to manage multiple projects concurrently, prioritize tasks, and meet deadlines while maintaining quality
- Project budgeting and expense tracking
- Previous work in ISO 9001:2015 environments, specifically related to compliance for development processes
- Cross-functional process development, documentation and training
- Project risk management, mitigation planning, and communication
- Experience managing multiple projects of varying complexity at once, prioritizing tasks and resources to meet deadlines while maintaining quality
- Involvement and management of engineering change control and sustaining projects
- Complex product development engineering work with hardware, software and firmware components.
- Project management within a stage-gate process methodology
- Holding project teams accountable to produce quality-driven product deliverables, including customer and product requirements, design reviews, verification and validation testing, design documentation, and experimental test reports.
- Strong project management skills, including project planning, scheduling, stakeholder management, risk management, and issue resolution
- Strong interpersonal abilities, including conflict resolution, leadership and influence, ability to comprehend and ensure comprehension of project team communications
- Demonstrated ability to lead and work effectively with cross-functional teams and stakeholders from top management, R&D, Operations, Quality, Service, Product Management, Marketing, and others
- Strong verbal, presentation, and written communications; strong emphasis on business communications to functional managers and directors
- Ability to build and maintain effective relationships, listening and adapting to stakeholder needs
- Ability to contribute technical discussions, challenge assumptions and design decisions, and drive towards more cost effective or faster to market solutions
- Proficient in project management and Microsoft Office tools, with ability to learn new tools as needed
Preferred:
- Mechanical or Electrical Engineering degree
- Understanding of Design for Six Sigma principles and statistical methods
- Experience with Jira and Confluence
- Experience with bioprocessing instrumentation and equipment NPI projects
- Agile software development lifecycle methodology
- Understanding of Design for Six Sigma principles
- Inherent drive for continuous improvement and education
- Agile and customer-centric mindset to product development
What Repligen Offers Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $97,000-$125,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.