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Process Development Principal Scientist Large Molecule Release Testing
2 months ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Process Development Principal Scientist Large Molecule Release Testing (LMRT)
Live
What you will do
Lets do this Lets change the world
In this vital role in a phase-appropriate GMP setting, you will lead a team of scientists to support lot release and stability study sample testing of early phase Tox and GMP materials in Large Molecule Release Testing (LMRT) labs in a timely and compliant fashion to enable pipeline progression.
Lead team to complete product release testing, stability testing and its associated activities within defined timeline and with high quality.
Ensure cGMP compliance requirements are met in day-to-day work.
Provide technical leadership in support of incoming method transfer/qualification, method optimization, troubleshooting method related issues, retest, and investigations.
Generating, analyzing, and critical review of analytical data/trending to support product release and stability, investigations, and regulatory submissions.
Provides timely training and mentoring to staff.
Effectively managing timelines and resources to delivery major achievements using methodological approaches.
Drive process improvement initiatives and collaboration with partner organizations.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Bachelors degree and 7 years of Scientific and GMP experience OR
Masters degree and 5 years of Scientific and GMP experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific and GMP experience
Preferred Qualifications:
Extensive experiences & SME in cell-based bioassay and binding assays used to test diverse modalities including monoclonal, bispecific antibodies, bispecific T-cell engagers (BiTEs), and other protein modalities.
Extensive experiences & SME in immunoassay and qPCR.
Extensive working experience in a fast-paced GMP environment and strong adherence to good documentation practices.
Previous experience successfully managing teams and leading cross-functional projects.
Self-motivated individual who can adhere to timelines and strive for delivering high quality results.
Strong troubleshooting and problem-solving skills, attention to details.
Excellent written and verbal communication skills.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
