Process Development Senior Scientist
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Amgen's Process Development organization is seeking a highly qualified candidate to join 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 candidate 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. The candidate must have excellent interpersonal and communication skills and demonstrated ability to work effectively in a global team environment.
- Develop technology to deliver multi-kilogram quantities of drug substance candidates in a safe, practical and efficient manner.
- Provide 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. Track record of successful application of said technology complying to current and emerging regulatory requirements (FDA, EMA, ICH, etc).=Improves the technical or scientific capabilities of the department and routinely answers questions on or resolves scientific/technical issues.
- Collaborates as synthetic drug substance subject matter expert in cross-functional teams.
- Work cross-functionally to author CMC regulatory documents and documentation in support of Amgen's regulatory filings.
- Develop processes amenable to cGMP operation and leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity.
- Effectively participates on drug substance development teams as a team member or team lead.
- Works cross-functionally with discovery and late-stage development chemistry teams to manage in-coming and out-going programs.
- Works effectively in a multi-disciplinary team of chemists, engineers and attribute scientists.
- Collaborates with other scientists and professionals outside the department including external suppliers as needed.
- 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
- Effectively organizes and conducts meeting
- Communicates effectively in individual and group situations and disseminates information to and from staff.
LEADERSHIP AND INFLUENCE
- Plans, coordinates and conducts work associated with process development studies for batch and continuous processes.
- Negotiates and collaborates interdepartmentally.
- Participates in departmental committees to address departmental and interdepartmental problem solving, and activities.
Supervising Others [May have direct report(s)]
- Ensures that safe laboratory practices are followed.
- Provides mentoring and expertise to less-experienced staff
- Trains staff and provides opportunities for the development of others
- Achieves work in a matrix organization through others who may or may not report directly to them, internally or externally.
- Organizes, facilitates, and analyzes key scientific data related to the identification or synthetic routes and the scale-up and manufacture of Amgen's clinical candidates
- Motivates, develops, and coaches staff while promoting team collaboration
- Applies effective management practices in the direction and development of others
DECISION MAKING AND JUDGMENT
- Anticipates, proactively detects and addresses problems related to department and interdepartmental activities
- Informs and consults management appropriately
Doctorate degree in Chemistry (Organic chemistry) and 2 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
Master's degree and 5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
Bachelor's degree and 7 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
- Ph.D. or equivalent in Chemistry (Organic Chemistry) and typically 5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
- A BS Scientist with a minimum of 14 years pharmaceutical industry or MS scientist 10 years experience 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.
- An external scientific track record of peer reviewed publications, scientific conference participation or participation in industry working groups or panels
- 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