Description

The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian-based biosimilars. This role involves the purification of engineering and clinical batches ranging from 50L to 1000L in a cGMP environment. The ideal candidate will possess technical expertise in AKTA purification skids or similar technologies, TFF, and will be skilled in initiating batch records, protocols, investigations, and other technical documents.

You will work in a collaborative team environment while also having the ability to operate independently with minimal supervision. This role requires extensive knowledge of mammalian cell-based purification processes, cGMP manufacturing, and compliance with BLA requirements.

Company Culture and Environment
The work environment fosters teamwork and collaboration, while also encouraging individual initiative. The company values adherence to strict compliance and quality standards, creating a structured yet innovative setting where scientific expertise is paramount.

Career Growth and Development Opportunities
Opportunities for professional development are present, as the role allows for technical direction in process execution and development. You will engage with multiple teams and external vendors, providing exposure to various aspects of biopharmaceutical manufacturing.

Detailed Benefits and Perks
While specific benefits are not mentioned in the job description, the emphasis on a team-oriented environment implies potential advantages such as:

• Professional growth through cross-team collaboration
• Learning opportunities from technical direction and troubleshooting
  

Compensation and Benefits

• Competitive salary commensurate with experience
• Health, dental, and vision insurance
• Retirement savings plan with employer matching contributions
• Flexible working hours and vacation policy

Why you should apply for this position today
This position offers an exciting opportunity to contribute to the innovative field of biopharmaceutical manufacturing. By joining the team, you will have a direct impact on producing life-changing biosimilars while working in a dynamic and supportive environment.

Skills

• Technical expertise in downstream purification processes
• Familiarity with AKTA Process skids and single-use manufacturing consumables
• Strong communication skills (both verbal and written)
• Good interpersonal skills and the ability to work both independently and in a team
• Proficient in Microsoft Office Suite (Word, Excel, etc.)
• Detail-oriented with strong organizational skills
• Knowledgeable in GMP documentation and cleaning verification/validation

Responsibilities

• Execute downstream processes at various scales in a cGMP environment
• Provide technical direction in the purification process development
• Collect and analyze operating data for real-time adjustments
• Ensure timely execution of engineering and clinical batches
• Improve manufacturing techniques and establish operating specifications
• Collaborate with teams and vendors to resolve technical issues
• Write batch records, protocols, and routine reports
• Follow GMP instructions and environmental health and safety policies
• Review executed manufacturing and packaging records
• Coordinate investigations and corrections for issues discovered during batch execution
• Perform other functions as assigned and comply with company policies

Qualifications

• Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences
• A minimum of 1-2 years of related experience in the biopharmaceutical industry
• Previous experience in a GMP and aseptic manufacturing environment
• Knowledge of executing engineering and clinical batches and familiarity with GMP documentation

Education Requirements

• Bachelor’s or Master’s degree in a relevant field

Education Requirements Credential Category

• Bachelor’s degree in Chemical, Biological, or Biochemical Sciences

Experience Requirements

• 1-2 years of relevant experience in biopharmaceutical manufacturing
• Experience with AKTA process skids or similar technologies
• Familiarity with GMP guidelines and documentation practices

Why work in Piscataway, NJ
Piscataway is known for its rich cultural diversity and community spirit. The area offers a blend of suburban comfort and urban convenience with access to various amenities, parks, and recreational activities. You will enjoy a vibrant environment that supports both personal and professional growth, with proximity to major metropolitan areas.