Senior Manager, NPI - site based, Redmond, WA

Job Title: Senior Manager, NPI – Site MSAT                                                       

Location: Redmond, Seattle, WA - with work between the two sites.

About Us: this is who we are

At Just-Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper?   #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge, …in our journey

We’re looking for a passionate and curious Senior Manager, NPI to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Senior manager leading the NPI team for early phase programs at Just-Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

What You’ll Do:

• Lead and provide oversight on project teams to implement the NPI process at J.POD Redmond and Seattle to support the start and rapid scale-up of commercial GMP manufacturing activities.

• Lead a team of NPI engineers for early phase programs and work closely with clients to reduce lead time to FIH studies

• Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations.

• Partner with supply chain to support Bill of Material development and demand planning for new products.

• Partner with Global MSAT & Engineering to conduct facility fit assessments and plans to support system updates needed for new product introduction.

• Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction.

• Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.

• Acting as a subject matter expert for regulatory and client inspection audits.

• Partner with Business Development, Supply Chain, and Manufacturing to support the Sales and Operation (S&OP) process.

• Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.

• Apply Operational Excellence principles to lead continuous improvement in NPI activities.

Who You Are:

• Masters (or Bachelors) degree in relevant field or related program with 10 (15+) years of pharmaceutical/biotech validation experience including a minimum of 3 plus years of experience leading a New Product Introduction program for biopharmaceutical products.

• Experience with people management and working across a matrixed organization – ability to delegate and think strategically.

• Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ commercial manufacturing.

• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.

• Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies

• Demonstrated leadership capabilities to build and mentor high-performing teams, drive change, and influence internal and external stakeholders

• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing

• Good interpersonal, team, and collaborative skills are required.

• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization

• Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.

• Experience in leading ri