Manufacturing Scientist

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.