Process Development Principal 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.

Basic Qualifications

Doctorate degree in Chemistry (Organic chemistry) and 7+ years of meaningful experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
Or

Master's degree and 10+ years of relevant scientific experience as outlined below

Or

Bachelor's degree & 13+ years of relevant scientific experience as outlined below

Job summary

Amgen's Process Development organization is seeking a highly qualified individual to join the Pre-Pivotal Drug Substance Technologies team responsible for developing creative solutions to prepare our small molecule, peptide, oligonucleotide and conjugate drug candidates. A principal scientist will lead cross-functional teams, drive technical and operational strategy for synthetic programs, provide and devise creative and phase-appropriate technology to deliver Amgen's growing synthetic portfolio. You will have a broad range of experience with synthetic processes to guide teams and junior staff toward innovative approaches toward process development. A track record of using established and novel technology that impact processes and programs will distinguish you. As an applicant, you should have excellent interpersonal and communication skills and proven ability to work effectively in a global team environment.

Scientific/technical

• 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 cross-functional product delivery teams) by delivering robust data packages supporting technical decision, regulatory documentation.
• Serves as a technical authority and keeps current in organic chemistry literature and related technology. Demonstrated successful application of said technology to large scale manufacturing in compliance with current and emerging regulatory requirements (FDA, EMA, ICH, etc).
• Improves the technical or scientific capabilities of the department and drives technology development in emergent arenas of chemical synthesis.
• 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.

Team experience

• Effectively participates on drug substance teams as a team member and team lead.
• Works cross-functionally with discovery and late-stage development chemistry teams to handle in-coming and out-going programs.
• Works effectively in a multi-disciplinary team of chemists, engineers and attribute scientists.
• Consistent record of collaboration with scientists and other professionals outside of department / company such as consortia or academic institutions.

Communication

• 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 meetings and holds staff accountable for decisions and actions held at meetings
• 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.
• Leads cross-functional committees to address departmental and interdepartmental problem solving, and activities.

Supervising Others

• Ensures that safe laboratory practices are followed.
• Provides mentoring and expertise to less-experienced staff
• Trains and seeks opportunities for staff
• 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 teamwork
• Applies effective management practices in the direction and development of others

Decision making and judgment

• Anticipates and passionately addresses problems related to department and interdepartmental activities
• Informs and consults management appropriately

Preferred Qualifications

• Ph.D. or equivalent in Chemistry (Organic Chemistry) and typically 10+ years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams
• A B.S. Scientist with a minimum of 20+ years pharmaceutical industry or MS scientist 15+ 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 dynamic team environment
• Excellent interpersonal, presentation, written and verbal skills

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.