Analytical Development Analyst

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.