Process Development Senior Scientist
Amgen is seeking a Process Development Senior Scientist in our Process Development team, to be based in our Cambridge, MA office. The Process Development Senior Scientist will report to the Process Development Scientific Director and will support the Pre-Pivotal Drug Substance Technologies team responsible for developing innovative solutions to prepare our small molecule, peptide, oligonucleotide and hybrid drug candidates.
The Senior Scientist will contribute to and lead cross-functional drug substance development teams, drive technical strategy for synthetic programs, provide and devise innovative and phase-appropriate technology to deliver Amgen's growing synthetic portfolio. The Incumbent will have a broad range of experience with synthetic processes to guide teams and junior staff toward creative and innovative solutions to prepare drug candidates. A track record of creative problem solving using established and novel technology that impact processes and programs will distinguish the successful candidate. Further, the Senior Scientist must have excellent interpersonal and communication skills and demonstrated ability to work effectively in a global team environment.
Responsibilities for the Process Development Senior Scientist include:
- Independently authors technical reports, regulatory filings, patents, peer reviewed publications and actively participates in cutting edge scientific conferences
- Conveys information and makes recommendations on scientific issues to senior management
- Develops technology to deliver multi-kilogram quantities of drug substance candidates in a safe, practical and efficient manner
- Provides significant contributions to drug substance development teams (e.g., product, process development and product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.
- Serves as a technical expert and keeps current in organic chemistry literature and related technology with a track record of successful application of said technology complying to current and emerging regulatory requirements (FDA, EMA, ICH, etc)
- Works cross-functionally to author CMC regulatory documents and documentation in support of Amgen's regulatory filings
- Develops processes amenable to cGMP operation and leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity batch and continuous processes
- Ensures that safe laboratory practices are followed.
- Provides mentoring and expertise to less-experienced staff
- Achieves work in a matrix organization through others who may or may not report directly to them, internally or externally.
- Motivates, develops, and coaches staff while promoting team collaboration
Doctorate degree and 2 years of experience contributing to and/or participating in scientific project teams
Master's degree and 6 years of experience contributing to and/or participating in scientific project teams
Bachelor's degree and 8 years of experience contributing to and/or participating in scientific project teams
Associate's degree and 10 years of experience contributing to and/or participating in scientific project teams
High school diploma / GED and 12 years of experience contributing to and/or participating in scientific project teams
- Ph.D. or equivalent in Chemistry (Organic Chemistry)
- An external scientific track record of peer reviewed publications, scientific conference participation or participation in industry working groups or panels
- 5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
- Experience solving issues in the development of a large-scale chemistry process
- Familiarity with catalysis, biocatalysis, synthetic continuous manufacturing and Process Analytical Technology (PAT) techniques
- Experience with design of final drug substance crystallization processes to control critical attributes including polymorph, particle attributes and purity
- Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques
- Experience implementing chemistry with contract manufacturing organizations
- Understanding of regulatory requirements for chemistry, manufacturing and controls (CMC) production including cGMP's and ICH guidelines
- Demonstrated ability to be effective and fungible in a fast-paced team environment
- Excellent interpersonal, presentation, written and verbal skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.