Job Description

Opportunity for an experienced Downstream Manufacturing Technician (multiple levels) to continue their career in downstream/upstream manufacturing. This role will be with our client who has a global footprint in both R&D and manufacturing within the biopharma industry.

Location: Middlesex County NJ

Direct Hire: 60,000-90,000 DOE

Schedule: M-F 1st shift (needs to be flexible to 2nd & 3rd Shift)

Column Chromatography experience required

Essential Duties & Responsibilities

• Perform downstream processing at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
• Provide technical guidance in the execution and development of purification processes.
• Utilize systems to collect and analyze operational data and make real-time adjustments to products, instruments, or equipment.
• Ensure timely execution of engineering and clinical batches.
• Develop equipment operating specifications and enhance manufacturing techniques.
• Collaborate with other teams and external vendors to address technical challenges and maintain production equipment.
• Follow GMP guidelines in the manufacturing area and lead efforts to uphold environmental health and safety policies.
• Oversee investigations and corrective actions for issues identified during batch execution.
• Perform additional tasks as assigned.
• Comply with all company policies and operational standards.

Requirements

Education and Experience

• Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with 1-3 years of relevant experience in the biopharmaceutical industry.
• Experience working in GMP and aseptic manufacturing environments.
• Proficiency in operating systems like AKTA Process skids (or similar) and familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.
• Knowledge and experience in executing engineering and clinical batches, as well as familiarity with GMP documentation.

Special Skills

• Ability to collaborate with team members and work independently; strong interpersonal skills.
• Excellent verbal and written communication skills; strong organizational skills and attention to detail.
• Basic computer proficiency, including knowledge of Word, Excel, and spreadsheets.
• Expertise in GMP batch manufacturing and packaging documentation, including auditing and review processes.
• Familiarity with cleaning verification and validation processes.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Job Tags

Similar Jobs