Manufacturing Scientist

We are currently hiring for a Downstream Manufacturing Scientist to join a dynamic and growing biopharmaceutical company. If you are passionate about working in the biotechnology field and have experience in manufacturing processes, we want to hear from you!

Shift: Second Shift (2 pm -10pm)

Location: Middlesex County, NJ

Pay: 80-100k Salary

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 4-5 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.