Quality Control Biochemistry Associate II

Location: Durham, NC

Schedule: Standard EST Business Hours

Duration: 6 month contract

Pay Rate: $33-38/hour

Position Summary

The Quality Control Biochemistry Associate II is responsible for supporting key functional, operational, and strategic activities within the QC Biochemistry laboratory, focusing on large molecule testing. This role supports in-process, release, method transfer, and validation testing activities while ensuring compliance with GLP, GMP, and site quality systems.

The successful candidate will perform biochemical testing, support investigations, maintain laboratory systems, and collaborate with Quality, Manufacturing, and cross-functional teams to ensure product quality and regulatory compliance.

Key Responsibilities

Biochemistry Testing & Laboratory Operations (85%)

• Perform in-process and release testing for large molecule products.
• Execute method transfer and method validation testing activities.
• Conduct routine biochemical analyses, including:
  • pH Testing
  • Appearance Testing
  • Osmolality
  • Protein Concentration Testing (UV, RI, and SoloVPE)
• Generate, review, and document analytical results in accordance with GMP requirements.
• Support laboratory investigations, including testing activities related to deviations and quality events.

Manufacturing & Process Support (10%)

• Support QC Biochemistry operations aligned with manufacturing and business schedules.
• Assist with process validation initiatives and related testing activities.
• Interface with Manufacturing and Quality teams to support production and release timelines.
• Contribute to continuous improvement efforts within the laboratory.

Quality Systems & Compliance (5%)

• Maintain effective laboratory systems to ensure the integrity, accuracy, and reliability of analytical results.
• Ensure compliance with all applicable GLP, GMP, and site quality requirements.
• Apply Biogen Quality Systems principles in daily laboratory operations.
• Support audit readiness and inspection preparedness activities.

Required Qualifications

Education

• Bachelor's Degree in a scientific discipline required (Biology, Biochemistry, Chemistry, Biotechnology, or related field preferred).

Experience

• Minimum of:
  • 2+ years of relevant experience with an MS degree, or
  • 3+ years of relevant experience with a BS degree.
• Experience working in a GMP-regulated laboratory environment.
• Experience performing analytical testing within Quality Control, Biochemistry, Pharmaceutical, Biotechnology, or related industries.

Preferred Qualifications

• Experience supporting large molecule or biologics testing.
• Experience with method transfer and method validation activities.
• Familiarity with laboratory investigations and deviation management.
• Experience working with electronic laboratory systems and GMP documentation practices.

Desired Skills & Competencies

• Strong understanding of GLP, GMP, and quality system requirements.
• Knowledge of biochemical testing methodologies and laboratory best practices.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to effectively collaborate across Quality, Manufacturing, and cross-functional teams.
• Strong attention to detail and commitment to data integrity.
• Ability to manage multiple priorities in a fast-paced laboratory environment.

Ideal Candidate Profile

The ideal candidate is a QC laboratory professional with experience in biochemistry testing within a pharmaceutical or biotechnology environment. They have hands-on experience performing release and in-process testing, understand GMP requirements, and are comfortable supporting investigations, method transfers, and validation activities. Experience working with biologics or large molecule products is highly desirable.

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