Address
Form of workHOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Engineer
Live
What you will do
Lets do this! Lets change the world!
The Senior Engineer will join Amgens Drug Product Process Engineering team in the Drug Product Technologies organization. This role will be a key contributor to drug product process development, commercialization, and life cycle management of Amgens parenteral product portfolio. The Senior Engineer will lead the technology transfers of Amgen drug products across all commercialization development phases and various parenteral modalities. As the technology transfer lead, the Senior Engineer must successfully integrate the knowledge and information generated by multi-functional teams with Amgens platforms, as well as clinical and commercial facilities capabilities to ensure success through the commercialization lifecycle. This position is based in Thousand Oaks, CA.
Key responsibilities for this role include:
Support technology transfers of clinical and commercial products into Amgens drug product manufacturing facility in Thousand Oaks for a variety of parenteral modalities:
Conduct make-a-batch exercises to determine facility fit and identify gaps
Design and implement offline and on-site drug product characterization studies
Provide manufacturing on-site support as needed
Evaluate product impact due to manufacturing process, production scale, equipment, and raw material changes
Author and own high-quality process technology transfer and other technical documents
Participate in authoring and reviewing relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral portfolio
Point of contact for early to late-stage drug product teams during process design by bringing awareness of tech transfer business process, manufacturing site capabilities, and collaborating with teams to address technical challenges
Work directly with clinical and commercial manufacturing in support of on-going production, new product introductions, new technology introduction, and process optimization
Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering (equipment, automation, chemical, mechanical) principles to support process scale-up
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance technology transfer projects as well as improvement initiatives
Deliver progress reports and presentations (including generation and upkeep of dashboard) to engage with and ensure that management is aware of the current status and progress
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 employee with these qualifications.
Basic Qualifications:
Doctorate degree OR
Masters degree & 2 years of Operations or Process Development experience OR
Bachelors degree & 4 years of Operations or Process Development experience OR
Associates degree & 8 years of Operations or Process Development experience OR
High school diploma / GED & 10 years of Operations or Process Development experience
Preferred Qualifications:
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools
Knowledge of aseptic processing, drug product manufacturing unit operations such as formulation, filling, lyophilization, capping, visual inspection, isolators, primary containers such as vials, syringes, cartridges, devices, disposables, and relevant cGMP regulations
Experience with conducting statistical evaluations of data to assess statistical significance, potential correlations, and process capability
The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
Knowledge of bringing new biotech products to market, across various dosage forms and delivery systems
Experience with clinical and marketing application regulatory filings
Problem solving and strong communication skills
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality
Ability to learn and act on dynamic information at a rapid pace
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.
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.
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