Process Development Sr Principal Scientist

Career Category

Process Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Process Development Senior Principal Scientist

Live

What you will do

Let’s do this! Let’s change the world! Amgen is currently seeking a Process Development Sr Principal Scientist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.

In this vital role you will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and/or siRNA programs. The Scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.

• Lead and mentor a group of analysts in supporting process development. Provide career development guidance to the team members.
• Lead an Attribute Sciences team to support synthetic small molecule, synthetic peptide, and/or SiRNA drug substance and drug product process development, manufacturing, release & stability testing and characterization.
• Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
• Define analytical control strategies and implement methodologies for development of late phase clinical programs.
• Thorough understanding of cGMP/ICH regulations, compendial requirements related to analytical method development and comprehensive control strategy development.
• Provide concise summary to cross-functional leadership for endorsement of key decisions.
• Oversee activities at contract manufacturing and testing sites.
• Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 8 years of scientific experience OR
• Master’s degree and 6 years of scientific experience OR
• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of scientific experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• 7+ years’ experience in the pharmaceutical or biotech industry, focusing on process and product development and analytical method development for synthetic drug substances and products.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
• Strong experience in synthetic small molecules, peptide or oligonucleotide method development, characterization, and analytical control strategy.
• Advanced technical expertise in analytical methodologies for process development and product characterization of synthetic products including LC, GC, MS, UV, KF, NMR, FTIR et al.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
• Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and re