Leads the creation of visual inspection defect standards to enable clinical and commercial new product introductions (NPIs) and support on-going manufacture of parenteral drug products to Amgen’s drug product manufacturing facility in Thousand Oaks.
Designs, implements and documents on-site DP characterization studies, working instructions, standard operating procedures, and protocols in support / ownership of visual inspection defect creations.
Author and/or own high-quality technical and GMP documents.
Ensuring all aspects of all visual inspection process development supports activities adheres to required policies and procedures, including safety and training.
Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & global standards).
Assist in the development of any existing visual inspection program to ensure continued compliance to the necessary regulations.
Build and sustain excellent relationships with partners – drug product teams, NPI, QA, Process Development and manufacturing teams throughout the Amgen global network to ensure alignment between program needs and site capabilities.
Build, maintain and improve visual inspection defect creations process.
Provide process development expertise for visual inspections and defect creations.
Demonstrate a deep understanding of Amgen’s drug product and primary container platforms, and support continuous improvement.
Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.
Acts as single Point of Contact (POC) to Amgen network as ATO defect creations leader.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Associate Scientist professional we seek is a go getter with these qualifications.
Basic Qualifications
Master’s degree
OR
Bachelor’s degree and 2 years of Engineering or Operations experience
OR
Associate’s degree and 4 years of Engineering or Operations experience
OR
High school diploma / GED and 6 years of Engineering or Operations experience
Preferred Qualifications
Advanced Degree in engineering, biotechnology, life sciences, or related discipline with 4+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
Demonstrated expertise in leading functional area deliverables in visual inspections and defect creations from planning through completion, with measurable impact to business outcomes.
Knowledge of aseptic processing and strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
Experience in cGMP manufacturing environment, knowledge of cGMP’s and other global regulatory requirements.
Demonstrated ability in leading multi-functional teams to advance complex projects to completion and positively influence peers and executive leadership on decision-making.
Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.
Experience with building strong relationships in a matrix team environment, collaborating with Process Development, Project Management, Manufacturing, Regulatory, Quality and Compliance.
Ability to learn and act on dynamic information at a rapid pace and escalate relevant issues to management when required.
Ability to independently design and execute characterization studies, author characterization protocols, working instructions, standard operating procedures, and technical reports
Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with limited oversight
Demonstrated track record of taking initiative in identifying and implementing innovative approaches and ideas.
Capable of organizing and communicating complex technical concepts to enable business decisions
Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
Demonstrated ability to use interpersonal skills to build strong technical relationships.
Self-motivation, adaptability and a positive attitude.
Excellent communication skills, both oral and written.
Ability to elevate relevant issues to project lead and line-management.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A 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
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
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- Salary Range
- 90,442.55USD -122,363.45 USD
