Career CategoryOperations
Job DescriptionProcess Development Principal ScientistWhat you will doLet's do this. Let's change the world. In this vital role you will head the research and development efforts related to manufacturing processes. They design, conduct, and interpret experimental studies and develop novel methodologies to improve efficiency and quality.
- Serves as the Attribute Sciences Representative on cross-functional project teams and collaborates effectively with scientists across multidisciplinary teams.
- Leads and drives the analytical assessment of a Pre-pivotal candidate biotherapeutic through development.
- Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.
- Applies advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.
- Evaluates analytical method performance and reliability, including the impact of proposed method changes.
- Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.
- Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.
- Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.
- Stays current in the field and evaluates emerging analytical technologies.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
OR
Master's degree and 5 years of Scientific experience
OR
Bachelor's degree and 7 years of Scientific experience
Preferred Qualifications:- Ph.D. in biochemistry, analytical chemistry, biophysics, pharmaceutical chemistry or a related life science field, with 2 years of industry experience.
- Strong leadership skills and ability to communicate in a team environment succinctly and effectively.
- Deeply critical thinking with a creative and problem-solving mindset.
- Highly knowledgeable in protein biochemistry and protein-based biotherapeutics.
- Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related
technologies to characterize protein therapeutics. - Strong laboratory skills, including experimental design and execution, complex data interpretation, and timely delivery of results.
- Familiarity with common biotherapeutic critical quality attributes, such as aggregation, fragmentation, deamidation, oxidation, and partial reduction, as well as tools used for their characterization and quantification.
- Ability to work independently to advance projects and studies within required timelines.
- Excellent written and verbal communication skills, with the ability to document, present, and discuss scientific results in a fast-paced, multidisciplinary environment.
What you can expect of usAs 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.comSalary Range141,836.95USD -191,897.05 USD
