Process Development Scientist
As part of the pre-pivotal synthetic technologies team, the candidate will be responsible for the technology to prepare Amgen's small molecule API candidates through early phases of development (late discovery to mid-phase clinical trials).
The ideal candidate will participate in drug substance development teams that develop innovative solutions to prepare small molecule drug candidates.
Develop technology to deliver Amgen's API candidates in a practical, efficient and safe manner. Serves as a technical expert and keeps current in catalysis-based synthetic technologies in chemistry and pharmaceutical development including literature and technology development for cutting edge activities. Assess, assimilate and execute new chemosynthetic and enzymatic transformations through internal innovation and from the external scientific community. Develop technology to deliver Amgen's API candidates in a safe, practical and, efficient manner. Manage catalysis-based projects from discovery through commercialization through internal and external resources applying innovative technology in a phase-appropriate manner. Provides significant contributions to drug substance development teams by providing drug substance updates, documentation, data interpretation. Improve the technical or scientific capabilities of the department and routinely answers questions on or resolves scientific/technical issues. Collaborate in cross-functional teams to develop Amgen's pipeline. Deliver processes amenable to cGMP operation and carry out deliveries of drug substance/key intermediates in a cGMP manufacturing environment. Efficiently execute mechanistic investigations including detailed kinetic analysis for process and novel catalyst design. Safe handling of pressurized and/or reactive gasses.
*Leads departmental or functional group activities related to a development project
*Effectively leads or participates on drug substance development teams as a team leader, team member, or primary department representative
*Identifies resources and develops timelines for project activities
*Collaborates with scientists outside the department
Oral and Written Communication
*Independently prepares technical reports and regulatory submissions
*Conveys information and makes recommendations on scientific issues to senior management
*Effectively organizes and conducts meetings
*Effectively communicates in individual and group situations
*Consistently demonstrates facilitation and listening skills
*Effectively disseminates information to and from staff
*Other functions may be assigned.
Master's degree and 4 years scientific experience
Bachelor's degree and 6 years scientific experience
Ph.D. in Chemistry (Organic Chemistry) and post-doctoral experience
2 years experience in the pharmaceutical, biotech, or related industry which includes participation and contribution to scientific project teams
A track record of demonstrated scientific accomplishments the field of synthetic organic chemistry will distinguish the successful candidate
Advanced scientific writing, problem solving skills and abilities to bring in new technologies
Excellent interpersonal and communication skills and demonstrated an ability to work effectively in a team environment
Experience solving issues in the development of a commercial large-scale chemistry process
Familiarity with the use of design of experiments (DOE) and Process Analytical Technology (PAT) techniques
An external scientific track record which may include 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