Downstream Manufacturing Associate Biopharma

Job Description

Job Description

Downstream Manufacturing Associate

Position Summary

We are seeking a motivated Downstream Manufacturing Associate to join our biopharmaceutical manufacturing team. This entry-level position supports the purification and processing of biologic drug substances using downstream manufacturing operations in a cGMP-regulated environment. This role is ideal for recent graduates looking to launch a career in biopharmaceutical manufacturing. Comprehensive on-the-job training will be provided.

Key Responsibilities

• Perform downstream manufacturing activities including filtration, chromatography, ultrafiltration/diafiltration (UF/DF), and bulk drug substance processing.
• Execute manufacturing processes according to batch records, standard operating procedures (SOPs), and current Good Manufacturing Practices (cGMP).
• Operate, assemble, clean, and maintain downstream processing equipment and single-use systems.
• Prepare buffers and process solutions required for manufacturing operations.
• Accurately complete batch records and manufacturing documentation following Good Documentation Practices (GDP).
• Monitor process parameters and report deviations, equipment issues, or process abnormalities.
• Maintain a clean and organized manufacturing environment while following safety and contamination control procedures.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, and Engineering teams to support production schedules and quality objectives.
• Participate in training programs and continuously develop technical knowledge of downstream bioprocessing.

Minimum Qualifications

• Bachelor's degree required in Biology, Chemistry, Biochemistry, or a closely related Life Science discipline.
• No prior industry experience required. Recent graduates are encouraged to apply.
• Basic understanding of biochemistry, protein purification, chemistry, microbiology, or laboratory techniques obtained through academic coursework or laboratory experience.
• Strong attention to detail and ability to follow written procedures.
• Excellent organizational, communication, and teamwork skills.
• Basic computer proficiency, including Microsoft Office.

Preferred Qualifications

• Academic laboratory experience with protein purification, chromatography, filtration, biochemistry, or analytical laboratory techniques.
• Exposure to cGMP principles, aseptic practices, or biopharmaceutical manufacturing through coursework, research, or internships.
• Familiarity with laboratory equipment such as balances, pH meters, pumps, filtration systems, or chromatography instruments.