Process Development Sr Scientist - Thousand Oaks

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Process Development Sr Scientist

What you will do
Let's do this. Let's change the world. In this vital role you will join Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organization's focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers, and live oncolytic viruses.

Located at our Thousand Oaks, CA office, the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

Supervise and provide technical support for a team that provides analytical support for late stage product development
Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program
Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
Manage activities at contract manufacturing and testing sites
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development
Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

Additional Qualifications/Responsibilities

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree
OR
Master's degree and 2 years of directly related life science experience
OR
Bachelor's degree and 4 years of directly related life science experience
OR
Associate's degree and 8 years of directly related life science experience
OR
High school diploma / GED and 10 years of directly related life science experience

Preferred Qualifications:

Doctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry or equivalent.
Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.
Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics.
Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF
Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.
Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
Strong problem solving and effective multi-functional interpersonal skills.
Ability to develop, validate,…