Senior Scientist Bioassay Quality Control (GMP) Site Based, Redmond, WA
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Job Location:
Redmond, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Senior Scientist Bioassay Quality Control (GMP)
Shifts: Day Shift MondayFriday Core Hours 8:00am5:30pm
Location: Seattle / Redmond WA (Onsite)
About Us: Who We Are
At Just Evotec Biologics curiosity fuels everything we do. We challenge assumptions explore new ideas and push the boundaries of whats possible in biologics development and manufacturing. As we prepare for Process License Inspections (PLI) and transition toward commercial readiness were building a team that thrives on scientific rigor operational excellence and a deep commitment to quality.
If youre someone who asks bold questions seeks meaningful answers and isnt afraid to dive deep into complex problemsyour curiosity belongs here.
#BeCurious with us.
The Role: Your Challenge in Our Commercialization Journey
We are seeking a GMP focused Senior Scientist Bioassay to support QC operations for late stage and commercial biologics this role you will be a key contributor to ensuring the quality consistency and regulatory compliance of in process drug substance and drug product testing across our Seattle and Redmond GMP facilities.
You will play a critical role in method execution method lifecycle management inspection readiness and data integrity excellenceall essential to our path toward commercialization.
This is a role for someone who is both scientifically sharp and operationally disciplined who can think creatively while executing flawlessly in a regulated environment.
Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Senior Scientist will provide the QC analysis of in-process drug substance and drug product samples in support of our GMP manufacturing operations at the Seattle and Redmond WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.
What Youll Do (GMP Heavy Responsibilities)
GMP Testing & Data Integrity
Perform routine and non routine GMP QC testing using Bioassay methods including:
oCell based potency assays
oELISA (HCP ProA binding assays)
oqPCR
Ensure ALCOA data integrity principles are followed in all documentation and electronic systems.
Deliver high quality timely analytical results to support batch release stability comparability and in process control programs.
Method Lifecycle & Technical Leadership
Partner with Analytical Development to support method qualification validation transfer and lifecycle management in alignment with ICH Q2/Q14 expectations.
Author review and approve GMP protocols reports method files and technical assessments.
Serve as a subject matter expert (SME) for Bioassay methods during:
oInternal audits
oClient audits
oHealth authority inspections (FDA EMA PMDA)
Quality Systems & Compliance
Lead and support GMP investigations including:
oOOS OOT deviations
oCAPAs
oChange controls
Ensure investigations are scientifically sound timely and inspection ready.
Support PLI readiness including document preparation data traceability and SME coaching.
Equipment & Laboratory Operations
Support equipment qualification and lifecycle (IQ/OQ/PQ calibration maintenance).
Maintain a state of audit readiness across QC labs including:
oLogbook review
oReagent and consumable management
oEnvironmental and safety compliance
Contribute to continuous improvement initiatives to enhance throughput robustness and compliance.
Leadership & Mentorship
Provide on the floor technical guidance to junior analysts.
Deliver training on GMP expectations method execution and data integrity.
Represent QC in cross functional meetings and operational planning sessions.
Who You Are (Qualifications & Competencies)
Required
BS in Chemistry Biochemistry Molecular Biology or related field with 5 years of GMP QC experience in biologics or biotechnology.
Strong hands on experience with Bioassay techniques (ELISA qPCR HCP ProA cell based potency).
Demonstrated experience supporting GMP inspections and regulatory compliance.
Working knowledge of ICH FDA EMA and USP guidelines relevant to QC testing.
Experience with electrophoresis or chromatography data systems (e.g. CE HPLC Empower).
Excellent communication skills and the ability to work cross functionally in a fast paced CDMO environment.
Proven ability to manage multiple priorities meet deadlines and maintain high quality standards.
Preferred
Experience in late stage clinical or commercial QC operations.
Prior involvement in PLI readiness or commercial launch activities.
Familiarity with LIMS ELN and electronic data integrity systems.
Why Join Us:
Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based.
Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.
Are You Still Curious
If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.
Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $92400 to $126500;this is a salary exempt role. Base salary offered may vary depending on the individuals 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 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.
Required Experience:
Senior IC
Key Skills
About Company
Evotec is a global biotechnology company committed to advancing drug discovery & development together with our partners for medicines that matter.
