Process Development Scientist
US – Massachusetts – Cambridge
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.
1. Develop technology to deliver Amgen’s API candidates in a practical, efficient and safe manner.
2. Participate in drug substance teams and collaborate cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner.
3. Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen’s small molecule regulatory filings.
4. Work with external partners to deliver key intermediate or drug substances in support of Amgen’s small molecule pipeline.
5. Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment.
•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.
*Other functions may be assigned.
Doctorate degree or Doctorate Degree completed by June 2018
Master’s degree and 5 years of Synthetic Organic Chemistry experience
Bachelor’s degree and 7 years of Synthetic Organic Chemistry experience
•Ph.D. or equivalent in Chemistry (Organic Chemistry); post-doctoral experience preferred
•2+ years of relevant 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 are highly desirable
•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
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.
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites, social media chat and/or unsolicited emails. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application or send checks to be deposited in bank accounts. When in doubt, please check to see if the position in question is posted on the Amgen career site. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov and thank you for your assistance.