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Manufacturing Scientist

Astrix
Middlesex, NJ Full Time
POSTED ON 1/24/2025
AVAILABLE BEFORE 2/21/2025

We are currently hiring for a Upstream 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!


Essential Duties & Responsibilities

  • Collaborate with a team of manufacturing associates and engineers to execute upstream batches.
  • Perform cell culture and bioreactor operations (single-use fed-batch bioreactors) at various scales.
  • Conduct harvest clarification processes using centrifuges and depth filters at multiple scales.
  • Ensure timely execution of engineering and clinical batches.
  • Develop operating equipment specifications and improve manufacturing techniques.
  • Utilize programs to collect and analyze operating data for real-time adjustments to products, instruments, or equipment.
  • Interpret and follow instructions provided in written, oral, diagram, or schedule form.
  • Adhere to GMP standards in the manufacturing area and lead compliance with environmental health and safety policies.
  • Review executed manufacturing and packaging batch records, along with associated supporting documents.
  • Coordinate investigations and implement corrections for issues identified during batch execution.
  • Perform additional tasks as required or assigned.
  • Comply with all company policies and standards.


Requirements

Education and Experience

  • Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with a minimum of 3 years of related experience in the biopharmaceutical industry.
  • Expertise in independently designing, executing, analyzing, and documenting all stages of process development.
  • Strong foundational knowledge and subject matter expertise in executing engineering and clinical batches.
  • Experience working in GMP and aseptic manufacturing environments.
  • Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.

Specialized Knowledge and Skills

  • Strong ability to work independently and collaboratively with team members; excellent interpersonal skills.
  • Effective verbal and written communication skills, along with strong computer and organizational skills.
  • Attention to detail and proficiency in basic computer programs, such as Word, Excel, and spreadsheets.
  • In-depth knowledge of GMP batch manufacturing and packaging documentation, including audit and review processes.
  • Familiarity with cleaning verification and validation processes.

Salary : $80,000 - $100,000

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