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  • Process Development Sr Scientist

    Amgen (Cambridge, MA)



    Apply Now

    Join Amgen’s Mission of Serving Patients

     

    At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

     

    Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

     

    Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

     

    Process Development Sr Scientist

     

    What you will do

     

    Let’s do this. Let’s change the world. In this vital role you will provide technical and project leadership, integrating effective cross functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen’s pipeline. The responsibilities of this candidate will include:

     

    + Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management

    + Design, plan, implement, and document formulation and process development studies

    + Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges

    + Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions

    + Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations

    + Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions

    + Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs

    + Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs.

    + Ability to travel domestically and internationally up to 10% of the time

     

    What we expect of you

     

    We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.

    Basic Qualifications:

    + Bachelor’s degree and 5 years of Scientific experience; Or

    + Master’s degree and 3 years of Scientific experience; Or

    + Doctorate degree PhD OR PharmD OR MD

    Preferred Qualifications:

    + Advanced degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field

    + Experience in pharmaceutical development and manufacturing

    + Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments

    + Experience with development and characterization of co-formulations

    + Experience with advanced drug delivery, e.g. sustained release technologies, targeted delivery systems, microfluidics

    + Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)

    + Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)

    + Critical thinking, problem solving and independent research skills

    + Strong project management skills, including the ability to manage one’s project resources (material, manpower, time, etc.)

    + Good organizational skills with strong attention to detail

    + Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally

     

    What you can expect from 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, including remote and hybrid work arrangements, where possible

     

    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.

     

    As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

     

    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. 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.

     


    Apply Now



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