Evotec
Senior Manager, NPI - site based, Redmond, WA
Evotec, Redmond, Washington, United States, 98052
Senior Manager, NPI - site based, Redmond, WA Join to apply for the
Senior Manager, NPI - site based, Redmond, WA
role at
Evotec Senior Manager, NPI - site based, Redmond, WA 3 days ago Be among the first 25 applicants Join to apply for the
Senior Manager, NPI - site based, Redmond, WA
role at
Evotec Get AI-powered advice on this job and more exclusive features. Job Title:
Senior Manager, NPI – Site MSAT
Before applying for this role, please read the following information about this opportunity found below.
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 risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design. Experience in developing submission packages for pharmaceutical product registration Experience in client relations and communications. Demonstrated success in leading multi-disciplinary teams that span multiple organizations Entrepreneurial drive to achieve business objectives.
Why Join Us
Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow. Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. Site based. Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged. Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of
Just-Evotec Biologics .
Let your curiosity guide your career— #BeCurious
and explore the endless possibilities at Evotec!
The base pay range for this position at commencement of employment is expected to be $112,560 to $154,100; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionProject Management and Information Technology Referrals increase your chances of interviewing at Evotec by 2x Sign in to set job alerts for “Senior Site Manager” roles.Senior Construction Manager, SEABEL, GREF – Workplace Design & Construction (WD&C) Seattle, WA $81,200.00-$181,600.00 24 minutes ago Senior Construction Manager, R2L Building Soltions and Engineering Team Bellevue, WA $81,200.00-$181,600.00 4 days ago Construction Manager, SoCal/Irvine , GREF – Workplace Design & Construction (WD&C) Seattle, WA $81,200.00-$181,600.00 1 week ago Pre-Construction Manager - Amazon AIR, NA Design and Construction, Amazon AIR Bellevue, WA $81,200.00-$181,600.00 6 days ago Construction Program Manager , NACF Design and Construction Bellevue, WA $81,200.00-$181,600.00 1 week ago Seattle, WA $120,000.00-$180,000.00 1 month ago Seattle, WA $132,000.00-$181,500.00 1 week ago Seattle, WA $110,000.00-$150,000.00 1 month ago Construction Program Manager, NACF Design and Construction - Induction Bellevue, WA $69,700.00-$155,800.00 1 week ago Construction Program Manager, NACF Design and Construction - Induction Bellevue, WA $69,700.00-$155,800.00 1 week ago Senior Manager, Digital Systems Site MSAT - Redmond, WA Redmond, WA $104,500.00-$193,500.00 2 weeks ago Operations Manager - Restoration/General Construction Kent, WA $100,000.00-$120,000.00 1 week ago Sr. Risk & Compliance Mgr, Timehub, Time & Pay Innovation Bellevue, WA $109,000.00-$185,000.00 3 days ago Imaging Center Manager ($30K sign on bonus) Seattle, WA $119,000.00-$189,000.00 1 month ago Bothell, WA $95,000.00-$125,000.00 1 week ago Mukilteo, WA $150,000.00-$190,000.00 12 hours ago Senior Underwriting Manager, Middle Market Construction Seattle, WA $106,000.00-$322,000.00 2 hours ago Seattle, WA $130,000.00-$180,000.00 3 months ago Principal Construction Manager – Data Center Builds Seattle, WA $110,000.00-$180,000.00 1 month ago Seattle, WA $104,000.00-$206,000.00 1 week ago Pre-Construction Manager, R2L Preconstruction Bellevue, WA $69,700.00-$155,800.00 2 weeks ago Redmond, WA $130,000.00-$450,000.00 1 week ago Construction Manager, R2L Building Solutions and Engineering Team Bellevue, WA $69,700.00-$155,800.00 2 weeks ago Bremerton, WA $60,000.00-$90,000.00 3 days ago Bellevue, WA $130,000.00-$450,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Senior Manager, NPI - site based, Redmond, WA
role at
Evotec Senior Manager, NPI - site based, Redmond, WA 3 days ago Be among the first 25 applicants Join to apply for the
Senior Manager, NPI - site based, Redmond, WA
role at
Evotec Get AI-powered advice on this job and more exclusive features. Job Title:
Senior Manager, NPI – Site MSAT
Before applying for this role, please read the following information about this opportunity found below.
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 risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design. Experience in developing submission packages for pharmaceutical product registration Experience in client relations and communications. Demonstrated success in leading multi-disciplinary teams that span multiple organizations Entrepreneurial drive to achieve business objectives.
Why Join Us
Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow. Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. Site based. Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged. Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of
Just-Evotec Biologics .
Let your curiosity guide your career— #BeCurious
and explore the endless possibilities at Evotec!
The base pay range for this position at commencement of employment is expected to be $112,560 to $154,100; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionProject Management and Information Technology Referrals increase your chances of interviewing at Evotec by 2x Sign in to set job alerts for “Senior Site Manager” roles.Senior Construction Manager, SEABEL, GREF – Workplace Design & Construction (WD&C) Seattle, WA $81,200.00-$181,600.00 24 minutes ago Senior Construction Manager, R2L Building Soltions and Engineering Team Bellevue, WA $81,200.00-$181,600.00 4 days ago Construction Manager, SoCal/Irvine , GREF – Workplace Design & Construction (WD&C) Seattle, WA $81,200.00-$181,600.00 1 week ago Pre-Construction Manager - Amazon AIR, NA Design and Construction, Amazon AIR Bellevue, WA $81,200.00-$181,600.00 6 days ago Construction Program Manager , NACF Design and Construction Bellevue, WA $81,200.00-$181,600.00 1 week ago Seattle, WA $120,000.00-$180,000.00 1 month ago Seattle, WA $132,000.00-$181,500.00 1 week ago Seattle, WA $110,000.00-$150,000.00 1 month ago Construction Program Manager, NACF Design and Construction - Induction Bellevue, WA $69,700.00-$155,800.00 1 week ago Construction Program Manager, NACF Design and Construction - Induction Bellevue, WA $69,700.00-$155,800.00 1 week ago Senior Manager, Digital Systems Site MSAT - Redmond, WA Redmond, WA $104,500.00-$193,500.00 2 weeks ago Operations Manager - Restoration/General Construction Kent, WA $100,000.00-$120,000.00 1 week ago Sr. Risk & Compliance Mgr, Timehub, Time & Pay Innovation Bellevue, WA $109,000.00-$185,000.00 3 days ago Imaging Center Manager ($30K sign on bonus) Seattle, WA $119,000.00-$189,000.00 1 month ago Bothell, WA $95,000.00-$125,000.00 1 week ago Mukilteo, WA $150,000.00-$190,000.00 12 hours ago Senior Underwriting Manager, Middle Market Construction Seattle, WA $106,000.00-$322,000.00 2 hours ago Seattle, WA $130,000.00-$180,000.00 3 months ago Principal Construction Manager – Data Center Builds Seattle, WA $110,000.00-$180,000.00 1 month ago Seattle, WA $104,000.00-$206,000.00 1 week ago Pre-Construction Manager, R2L Preconstruction Bellevue, WA $69,700.00-$155,800.00 2 weeks ago Redmond, WA $130,000.00-$450,000.00 1 week ago Construction Manager, R2L Building Solutions and Engineering Team Bellevue, WA $69,700.00-$155,800.00 2 weeks ago Bremerton, WA $60,000.00-$90,000.00 3 days ago Bellevue, WA $130,000.00-$450,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr