Analytical Development Analyst - Hopewell, United States - Randstad Life Sciences

Description

Job Description

Title: Analytical Development Analyst

Duration: 12 Months

Pay Rate: $48/hr on W2

Location: Hopewell, NJ

Duties:
Perform analytical tests to support process development and transfer analytical methods to QC department.

Essential Functions of the job:

· Write SOP, experimental methods, and reports. Perform routine analytical tests (e.g., SEC, CE, ICIEF, Protein A) to support the upstream and downstream process development.

· Support the development and transfer of analytical methods of biologics drugs (including monoclonal antibodies, bispecific antibodies, ADC).

· Understand CMC process of biologics drugs, and operation specification for QC and QA.

· Understand the quality requirement of biologics drugs application, cooperate with the application to the complete the experiments or reports.

· Support sample preparation, reagent management, stable sample management.

Skills:

Required

· Antibodies

· HPLC

· Elisa

· Analytical chemistry

· Biochemistry

Core Competencies, Knowledge, and Skill Requirements

· Working experience in an FDA-regulated biotechnology, pharmaceutical company are required.

· Proficient in analytical chemistry or biology background, skilled in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) analysis methods, including but not limited to HPLC, UPLC, CE, Elisa.

· Credible and confident communicator (written and verbal) at all levels.

· Strong analytical and problem-solving ability.

· Ability to prioritize, demonstrating good time management skills.

· Self-motivated, with the ability to work proactively using own initiative.

· Committed to learning and development.

Computer Skills:

· Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Travel:

· Must be willing to travel approximately 10%

· Ability to work on a computer for extended periods of time

Significant Contacts: Interacts with all levels of employees.

Education:

· Minimum/at least 2+ years working experience with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline.

Company Description