Process Development Senior Scientist

Amgen • Cambridge, MA

3d • Onsite

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Senior Scientist What you will do Let’s do this. Let’s change the world. In this vital role, you will work as a Process Development Senior Scientist within Pivotal Drug Product Technologies at Amgen's Process Development hub in Cambridge, MA. This group 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). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.

Requirements

• Doctorate Degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master's Degree and 3 years of Scientific Experience OR Bachelor’s Degree and 5 years of Scientific Experience

Nice To Haves

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area.
• Experience in pharmaceuticals/biotechnology or related field.
• Experience with artificial intelligence tools, coding/scripting for automated data analysis and modeling.
• 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 data visualization tools or packages, such as Tableau or Spotfire.
• Experience including 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 one’s project resources (material, people, 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.

Responsibilities

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management.
• Design, plan, execute, 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 digital data management and analytic techniques to mine and organize data (including text) to build quantitative models and qualitative descriptions that inform and support 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 team members on progress towards achievements and forthcoming program needs.
• Ability to travel domestically and internationally up to 10% of the time

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior