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!