Process Development Scientist

Category: Process Development
Job ID: R-48586
Location: US – Massachusetts – Cambridge
Posted Date: December 12, 2017

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.

KEY RESPONSIBILITIES*:

SCIENTIFIC/TECHNICAL

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.

Team Experience

•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.

BASIC QUALIFICATIONS:

Doctorate degree or Doctorate Degree completed by June 2018

OR

Master’s degree and 5 years of Synthetic Organic Chemistry experience

OR

Bachelor’s degree and 7 years of Synthetic Organic Chemistry experience

PREFERRED QUALIFICATIONS:

•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.

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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.

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