Downstream Manufacturing Associate

Downstream Manufacturing Scientist

Full-time, on-site position – New Jersey (relocation support available)

This role focuses on the execution of downstream purification operations to support the manufacture of recombinant proteins for mammalian-derived biosimilars. The successful candidate will be responsible for running engineering and clinical-scale purification processes within a cGMP manufacturing environment. The position requires hands-on expertise in downstream unit operations, GMP documentation, and cross-functional collaboration.

Key Responsibilities

• Execute downstream purification activities including harvest clarification, chromatography, and ultrafiltration/diafiltration (UF/DF) at pilot and manufacturing scale
• Prepare, set up, and operate downstream processing equipment and single-use systems in accordance with approved procedures
• Perform buffer preparation, column packing (where applicable), and filtration operations
• Accurately complete GMP batch records, logbooks, and supporting documentation in real time
• Maintain strict aseptic practices and contamination control in cleanroom environments
• Support equipment and facility readiness, including cleaning, setup, and area turnover
• Follow cGMP, SOP, and EHS requirements with a strong focus on compliance and data integrity
• Participate in shift-based operations, including potential nights and weekends on a rotational basis

Qualifications

• Associate’s or Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or a related field
• Typically 2–6 years of experience in downstream biologics manufacturing (Associate II / III level or equivalent)
• Hands-on experience with chromatography systems, filtration, and buffer preparation required
• Comfortable working in GMP cleanroom environments with full gowning requirements
• Detail-oriented, dependable, and able to work effectively in a team-based manufacturing setting

Technical Skills & Competencies

• Practical knowledge of downstream unit operations, including chromatography and UF/DF
• Ability to work independently while collaborating closely with cross-functional teams
• Strong verbal and written communication skills with good organisational habits
• Proficient in basic computer applications, including Word and Excel
• Solid understanding of GMP manufacturing documentation, batch record review, and audit readiness