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Process Development Senior Scientist
4 months ago
HOW 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.
Process Development Senior ScientistLive
What you will do
Lets do this Lets change the world In this vital role you will work as part of a group that is responsible for late stage drug product formulation and process development for biologics modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins).
Design, plan, and complete laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge. Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization. Author and review guideline documents, technical protocols, and reports. Author and review regulatory sections in support of IND and marketing application submissions. Lead multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks. Perform data analysis using sophisticated statistical/analytical techniques with a proficiency in statistical analysis software. Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs. Effectively and consistently connect with management, multi-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs. Ability to travel domestically up to 10% of the time. WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: Bachelors degree and 5 years of Scientific experience OR Masters degree and 3 years of Scientific experience OR Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] Preferred Qualifications: Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area. 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field. Knowledge of/experience with formulation and commercial process development for liquid and lyophilized drug products. Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up. Understanding of physical/chemical stability of proteins and how process related stress impacts product quality. Experience with coding/scripting for automated data analysis and modeling. Experience with data visualization tools or packages, such as Tableau or Spotfire. Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiment. Critical thinking, problem solving and independent research skills. Strong project management skills, including the ability to lead ones project resources. Good organizational skills with strong attention to detail. Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally. ThriveWhat 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 nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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.