Process Development

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Job description

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.

Responsibilities include:

• Developing and implementing state-of-the-art and fit-for-purpose potency and biological characterization methods for product 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

Basic Qualifications

• Doctorate degree in Cell Biology, Molecular Biology, Immunology or Biochemistry discipline OR
• Masters degree & 2 years of Scientific experience OR
• Bachelors degree & 6 years of Scientific experience

Preferred Qualifications:

• 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 immunology preferred
• 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

Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood

Join Us

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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