Manufacturing Scientist

Opportunity for an experienced Upstream Manufacturing Scientist (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
• Terms: Direct Hire
• Salary: $80-100k/yr.

What you will be doing:

• Work closely with manufacturing associates and engineers to execute upstream batch processes.
• Perform cell culture and bioreactor operations (single-use fed-batch bioreactors) across various scales.
• Carry out harvest clarification processes using centrifuges and depth filters at multiple scales.
• Ensure timely execution of engineering and clinical batches.
• Develop equipment specifications and optimize manufacturing techniques.
• Leverage programs to collect and analyze operational data, making real-time adjustments to products, instruments, and equipment.
• Interpret and follow instructions in written, oral, diagrammatic, or scheduled formats.
• Adhere to GMP standards in the manufacturing area and lead compliance with environmental health and safety regulations.
• Review completed manufacturing and packaging batch records and supporting documentation.
• Coordinate investigations and implement corrective actions for any issues identified during batch execution.
• Perform additional duties as assigned.
• Comply with all company policies and standards.

What you bring to the company:

• Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences, with at least 3 years of relevant experience in the biopharmaceutical industry.
• Proven expertise in independently designing, executing, analyzing, and documenting all phases of process development.
• Strong foundational knowledge and subject matter expertise in executing both engineering and clinical batches.
• Hands-on experience in GMP and aseptic manufacturing environments.
• Familiarity with single-use manufacturing consumables, such as bags, tube sets, columns, and process manifolds.  Proven ability to work both independently and collaboratively within a team; excellent interpersonal skills.
• Strong verbal and written communication skills, with advanced computer and organizational abilities.
• High attention to detail and proficiency in basic software, including Word, Excel, and spreadsheets.
• In-depth understanding of GMP batch manufacturing and packaging documentation, including audit and review procedures.
• Knowledge of 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**