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Thermo Fisher Scientific Senior Manager, Process Engineering in Plainville, Massachusetts

Job Description: Senior Manager, Process Engineering

Location/Division Specific Information

Thermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

The role is based at any one of the VVS sites in Massachusetts (Cambridge, Lexington, or Plainville), but time may be spent at all VVS facilities including up to 10% travel to the Alachua, FL facility or other locations.

How will you make an impact?

The Sr. Manager, Process Engineering reports to the Director of Process Engineering in VVS' global engineering organization. (S)he will serve in a global role, leading a team developing and deploying strategic plans for process equipment platforms and providing strategic process/automation/equipment engineering guidance into design and operational philosophy across all VVS sites. The primary purpose of this role is to provide strong technical leadership overseeing the aligned development and deployment of strategic plans to evolve and improve equipment platforms. The Sr. Manager will partner with other technical and operations leaders across the business to evaluate technologies, identify areas of risk and opportunity, and prioritize/drive progress on improvements that will provide meaningful business impact.

What will you do?

Team and cross-functional leadership

  • Lead individuals and multi-functional teams in the identification of key process opportunities and the identification and development of best globally available equipment and systems solutions. Lead project teams on the design and implementation of novel and custom equipment technologies.

  • Collaborates with other global engineering groups and leaders, and other technical groups in Process Development, Process Sciences, Manufacturing Sciences & Technology on innovative technical solutions and aligning platform technology plans

  • Vendor Relationships / Management - Strengthen partnerships with key vendors to facilitate issue resolution, after sales support, etc.

  • Communicate proactively with stakeholders, senior leaders and sites regarding activities, progress, issues and resolution plans related to supported activities.

Process Engineering & Equipment Design

  • Maintains knowledge of contemporary single-use technologies, viral vector manufacturing platforms, equipment innovations, and regulatory standards

  • Develops and maintains equipment strategic plans for VVS

  • Operationalizes strategic plans into actionable projects and obtains stakeholder buy-in and support

  • Evaluates methods and equipment to meet performance, robustness, safety, and quality requirements

  • Interfaces with site teams to maintain strong understanding of equipment-related issues across manufacturing and process labs

  • Provides technical guidance and support for the design and implementation of upstream, downstream, and drug product equipment for viral vector products. Ensure manufacturing processes and equipment are fit for purpose for drug substance and drug product operations.

  • May sponsor or lead/co-lead complex projects involving operational/technical team(s) within and across sites and departments

  • Own creation, lifecycle management, and deployment of relevant Good Engineering Practice standards, platform equipment specifications, and other engineering best practices

  • Contribute to the strategic development of a system to manage the lifecycle of equipment platforms used across VVS manufacturing sites.

  • Support facility fit of potential client processes to determine the suitability of the facility and equipment for new business and business expansion projects

  • Provide subject matter expertise to other site or global engineering projects and initiatives as needed.

  • Keep abreast with external industry groups (ISPE, PDA, BPOG, etc.)

How will you get here?

Education

  • Bachelor's degree in engineering, science, or related field, with evidence of operational, leadership, or professional experience.

Experience

  • Ten years' experience in process development, operations or engineering in the biologics manufacturing industry

  • Experience with people and project management

  • Experience with biologics drug substance and/or drug product manufacturing

  • Experience with single-use technologies strongly desired

  • Experience with drug product filling and isolator technologies

  • Experience with VHP sanitization desired

Knowledge, Skills, Abilities

  • In depth understanding of general cGMP standards and practices

  • Strong knowledge of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems

  • Candidate must have the capability to define and set technical direction for process unit operations

  • Candidate must also have the capability to define user requirements in support of designing or procuring manufacturing equipment

  • Works independently on most assignments using knowledge and work experience to achieve desired results

  • Uses a variety of communication tools and techniques to present complex ideas and anticipates potential objections and influences others

  • Operates independently in ambiguous situations using knowledge and work experience to achieve desired results

  • Develops innovative solutions and ideas, takes appropriate risks to challenge the status quo resulting in enhanced processes.

  • Strong understanding of applicable regulatory requirements. Audit experience is preferred.

  • Strong technical documentation review and revision experience

  • Strong interpersonal and communications skills; written and oral

  • Ability to set goals and direction for others

  • Comfortable supporting concurrent issues

  • Working with both hands-on and remote based staff

  • High ethical standards to support a professional business code of conduct.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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