Job ID: R-104163 Location: Cambridge, MA, US 02139
This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.
Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
May manage a team of lab associates to accomplish project deliverables
Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
Participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
Plans and manages the generation of detailed analytical procedures used for product lot release, stability testing, and/or characterization including timelines, milestones, methodological approaches, expected results, and necessary resources
Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities
Designing and implementing analytical projects involving method development, qualification, and transfer
Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
Doctorate degree in Cell Biology, Molecular Biology, Immunology or Biochemistry discipline
Master's degree & 2 years of Scientific experience
Bachelor's degree & 6 years of Scientific experience
Expertise in cell culture and bioassay development for the quantitative determination of the biological activity of large molecule therapeutics
Expertise in cell-based bioassay development (method optimization, qualification, validation, technical transfer)
Expertise in virology and oncolytic viruses preferable
Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies
Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
Excellent documentation skills, is detail oriented
Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines preferred
Ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R&D and commercialization
Experience with automation is desirable
Innovation - positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve unit performance
Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered; works well in teams
Performance management - may ensure direct reports are adequately oriented and developed to perform at a high level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning
Leadership - supports teamwork and collaboration
Communication - establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.PI123693585