Job Title: Senior QC Scientist Raw Materials
Days: Monday to Friday.
Location: Site based Redmond WA
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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.
Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!
The Role: / your challenge in our journey
Were looking for a passionate and curious Senior QC Scientist Raw Materials to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As a Senior QC Scientist Raw Materials at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
This position oversees and participates in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing. This role works collaboratively with other teams to ensure that raw materials are released in a compliant manner prior to their need-by dates. The role requires extensive cGMP compliance experience exceptional attention to detail and experience designing and implementing efficiency improvements.
What Youll Do:
Lead a QC raw materials testing program to support commercial manufacturing.
Oversee the inspection sampling and testing of incoming raw materials prior to use in manufacturing according to US and EU GMP requirements.
Ensure materials are sampled in accordance with SOPs entered into the data management systems and are available for use on time.
Participate in the qualification of raw materials via external and in-house testing.
Serve as subject matter expert in review of raw material specifications.
Participate in vendor audits as a technical advisor.
Oversee the daily routine activities of the raw materials group provide data review and ensure the operation remains compliant at all times.
Collaborate with Quality Assurance Manufacturing Materials Management external vendors and other functions to ensure internal timelines testing TAT and team milestones are achieved.
Author and maintain required cGMP documentation such as SOPs and guidance documents.
Oversee verification of assays at external testing labs.
Identify gaps design collaborative solutions and implement improvements.
Participate in external testing labs QC laboratory investigations deviations OOS and CAPAs.
Onboard and qualify analytical equipment (e.g. FTIR) as resources permit.
Who You Are:
BS in Chemistry or related field with 8 years relevant Quality experience and 10 years experience in industry including a minimum of 3 years of hands-on industry experience managing a cGMP Raw Material team.
Extensive experience with raw material sampling including handling of powders and liquids using aseptic techniques.
Knowledge of cGMP raw materials tests including pH conductivity osmolality moisture appearance FTIR HPLC etc.
Knowledge of verification and validation of assays required for raw material testing.
Extensive knowledge of regulatory requirements and guidelines (ICH CFR FDA).
Extensive knowledge of GDPs GMPs multi-compendial assays (USP EP JP).
Excellent communication and collaboration skills.
Attention to detail highly organized able to meet schedules and timelines and handle multiple priorities.
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; 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 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.
Required Experience:
Senior IC
Evotec is a global biotechnology company committed to advancing drug discovery & development together with our partners for medicines that matter.