Amgen Senior Scientist Bioprocess Development in Cambridge, Massachusetts

We are seeking a talented professional for a leadership position at Senior Scientist level based in Cambridge MA. The position is within the Process Development organization, and focused on the development of drug substance manufacturing processes for biologics.

Responsibilities

The successful candidate will lead a laboratory-focused group of cell culture and purification scientists who develop robust commercial processes to advance Amgen's biologics pipeline, biosimilar pipeline and life cycle management of Amgen's commercial portfolio. As part of this leadership role the successful candidate will develop strong teams and support staff in career development. The role will also require leadership of cross-functional teams that deliver commercialization packages for drug substance manufacturing processes. The scope of work and responsibility span commercial process development, process characterization, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies. In addition, the successful candidate will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.

Basic Qualifications

Doctorate degree and 2 years of scientific experience

Master's degree and 5 years of scientific experience

Bachelor's degree and 7 years of scientific experience

Preferred Qualifications

Doctorate in biological science discipline or chemical engineering with 5+ years of experience

Expertise and experience in mammalian cell culture and cell sciences

Extensive experience in development and/or support of commercial manufacturing processes, including process scale-up

Experience in CMC commercialization process

Leadership of a lab group or leadership experience of functional or cross-functional project teams

Demonstrated results from leadership opportunities

Track record of innovation and implementation of new technologies

Experience in authoring BLA sections and interaction with regulatory

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.