Amgen

Process Development Scientist

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 29, 2019
Ref
R-73773
Required Education
Doctorate/PHD/MD
Position Type
Full time
Within Amgen's Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Thousand Oaks, CA, is seeking a highly motivated, and team-oriented individual for the position of Process Development Scientist. The SET group serves as a key Drug Product Technology interface with the partners in Process Development and Research & Discovery. Its main responsibilities include:

• Solid state form selection and characterization support for DS and DP process development for synthetics and biologics programs.

• Generation of fundamental knowledge to establish form development strategy and Target Product Profile.

• Synthetics molecule assessment (developability assessment) and preclinical formulation support.

• Biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.

• Early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP) process.

In this role, the scientist will play a proactive role in the solid-state form evaluation and characterization and the application of innovative materials science approaches to guide the DS and DP development.

Responsibilities:

• To design and execute screening experiments to help identify polymorph, salt & co-crystal forms of various APIs and intermediates as well as to determine relative stability & conversion relationships among different forms.

• To recommend a suitable solid-state API form, identify any gaps/risks associated with process development and provide mitigation strategies to the pre-clinical and early formulation development teams.

• To assess structure-property relationships of APIs and provide material options with the desired physicochemical properties for DS/DP development.

• To support departmental activities including training staff and presenting scientific results at internal/external meetings.

• To build and maintain strong working relationships with internal and external partners.

• To contribute to regulatory and intellectual property filings.

• To keep track of new technology in the field of pharmaceutical materials science and collaborate with external groups.

Basic Qualifications:

Doctorate or Doctorate degree completed by July 2019

OR

Master's degree & 4 years of scientific experience

OR

Bachelor's degree & 6 years of scientific experience

Preferred Qualifications:

• Doctorate Degree in one of the following areas: Materials Science, Chemical Engineering, Organic Chemistry, Physical Chemistry, Pharmaceutical Science or a related scientific discipline with 1+ years of post-doctoral or industry experience

• Strong background in pharmaceutical materials science and solid-state chemistry is required with a successful track record of peer-reviewed journal publications and presentations

• Hands-on experience and expertise in form screening and crystallization to assess polymorphism, salt/co-crystal formation and solvate/hydrate formation

• In-depth experience in solid-state analysis and instrumentation (DSC, TGA, XRD, crystallography, microscopy, DVS, particle characterization, Raman, IR, etc.)

• Good understanding in crystallographic in-silico and informatics tools

• Knowledge in amorphous material characterization

• Working knowledge in preformulation techniques such as HPLC analysis, physicochemical evaluation (solubility, pKa, LogP, etc.)

• Excellent written, verbal, and presentation skills: ability to distill, craft and present key messages relative to diverse audience requirements

• Problem solver with proactive attitude and ability to collaborate and work in a cross-functional and multidisciplinary environment

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 committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.