Process Development Principal Scientist - Cambridge MA

Company: Msccn
Location: Cambridge
Posted on: April 1, 2026

Job Description:

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Process Development Principal Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Cambridge, MA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics. The Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process. Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions Driving continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering Serving as subject matter expert and help drive standard methodologies and technical advancements Serving as a Drug Product Team Lead of matrixed team to develop strategy in support of commercialization and life cycle management of Amgen’s pipeline Managing a team of engineers and scientists to advance program and functional objectives Expanding utilization of advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis Working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships Ability to travel domestically and internationally up to 10% of the time. Additional Qualifications/Responsibilities What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual 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 Scientific experience Preferred Qualifications: Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area 8 years of experience in pharmaceuticals/biotechnology 5 years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring Technical leader with demonstrated results driving forward programs Experience in drug product regulatory strategy, RTQs, and agency engagement Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js) Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab) Experience participating and leading global multi-functional teams Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings Strong problem solving and effective multi-functional interpersonal skills Willing and able to learn new technologies at a rapid pace Salary Range 155,244.00 USD - 183,930.00 USD

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