Associate - Amgen

Onsite 100% USTO working in lab
Title: Associate #11490
Pay Rate: up to $24/hr
Location: Thousand Oaks, CA 91320
Length: 1 year contract + Possible extension

Job Description:

• The company is seeking a Process Development Associate – Attribute Sciences (analytical) to join our team and work from our beautiful company’s Thousand Oaks, CA campus. This position will be within our Pre-Pivotal Attribute Science Biologics team in Process Development.

• The focus of this position is on analytical testing and method qualification to support earlier phase clinical product development to advance the company’s portfolio. The successful candidate will perform method development, process sample testing, method qualification activities in support of early phase portfolios for the company’s pipeline.

• Key Responsibilities:

• Under general supervision, this position will perform routine procedures and testing in support of the LC-CE group (liquid chromatographic analysis using UHPLC/HPLC and capillary electrophoresis using Beckman CE instruments).

Responsibilities:

• Performing routine laboratory procedures. Execution of HPLC, UHPLC, and CE experiments for routine analytical testing of bio-therapeutic proteins

• Document, analyze, and report results following GDP and GLP requirements including routine documenting, computing, compiling, interpreting, and entering data from routine analysis.

• Maintaining and operating specialized equipment

• Transfer and qualify analytical methods under guidance of a senior member of the Attribute Sciences team.

• Author, review, and data verify technical documents and standard operation procedures.

• Must learn and comply with safety guidelines, which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks

• Support develop and optimize analytical methods utilizing HPLC/UPLC, CE, and Mass Spec technologies to support the lead candidate selections and improve method performance for different modalities at Dev MA and FIH stages with high efficiency and throughput.

• Analyses utilizing size-exclusion, cation and anion exchange, affinity, and reversed phase HPLC/UHPLC and CE techniques.

• Performing hands-on testing support of the HPLC/UHPLC and CE method development and molecule characterization activities. Investigate method performance and reliability and evaluate the impact of proposed changes.

• Generating, analyzing, and critical evaluation of analytical data to support product development characterization, investigations, and regulatory submissions

• Qualification methods to enable transfer of methods to the Rapid Analytics team and early phase GMP lab and documenting method establishment in method transfer reports.

Basic Qualifications:

• Bachelor’s degree and 0 - 2 years of experience in analytical laboratories, pharmaceutical or biotechnology industry

Preferred Qualifications

• Educational background in Chemistry, Biochemistry, or related Life Sciences

• Quick learner and with some working experience in analytical labs

• Strong organizational skills, including ability to follow assignments through to completion

• Strong word processing, presentation, database and spreadsheet application skills

• Strong communication (both written and oral), facilitation and presentation skills

• Excellent organizational skills and a great attention to detail

• Ability to make independent decisions based on system output

• Self-motivated, able to interface effectively with various levels, and able to prioritize to meet deadlines

• Team player committed to working in a quality environment

• Strong analytical lab skills and technical knowledge of proteins and peptides

• Strong organization skills and acute attention to details

• Proficient using HPLC and UHPLC. Experience with capillary electrophoresis is a plus

• Experience with EMPOWER, Chromeleon, and 32 Karat software is a plus

• Ability to follow established protocols and procedures, and ability to develop new or revise existing protocols and procedures as needed

• Strong computer and scientific skills, proficient in Microsoft Excel, Word, and PowerPoint

• Excellent communication (oral and written) skills

• Ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Top Must Have Skills:

• Good communication skills

• Have some analytical chemistry knowledge

• Well-organized and ability to multitask

• Prior lab experience