Sr. Scientist​/Engineer - TS​/MS Lab Downstream

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Full Time Branchburg, NJ, US

5 days ago Requisition

Salary Range: $87,000.00 To $ Annually

This position is responsible for laboratory-based technical support of manufacturing operations. This includes the design and execution of downstream laboratory experiments involving continuous improvement, process validation and technology transfer. It is required to have an understanding of recombinant biologic production process and an in-depth knowledge of the science behind the molecule and the process.

• Responsible for providing laboratory-based experiments involving process support, process improvement and technology transfer.
• Transfer laboratory-scale downstream models for late-stage clinical and commercial manufacturing, ensuring robust and scalable methods are adopted.
• Apply scientific and technical knowledge to optimize purification processes and enhance service delivery.
• Present process data and analyses in various internal meetings.
• Demonstrates strong business and technical expertise by developing and implementing effective solutions for products and processes across multiple business areas. Actively influences decision-making and drives progress within their area of responsibility, project teams, and functional groups.
• Collaborates with R&D and Manufacturing to define, develop, transfer, and implement fit-for-purpose downstream process control strategies.
• Authors/reviews laboratory reports for all studies performed. Participate in data integrity review for laboratory study documentation. Reviews of technical documents for content and accuracy.
• Address and resolve unforeseen issues in purification processes, making decisions that impact standard and non-standard projects.
• Make decisions that impact a range of standard and non-standard projects. Accountable for quality, interpretation and reporting of immediate work activities and outcomes.
• Manage projects and provide leadership to small teams focused on downstream purification.
• Understands and performs all job responsibilities under Good Laboratory Practices (GLP) guidelines, meeting safety requirements. Understands cGMP guidelines and regulatory expectations.

• Identifies internal and external customer requirements and develops solutions to meet customer’s needs.

• May direct or advise experimentation of junior colleagues.

• Experience in protein purification manufacturing processes.
• Strong data-driven decision-making and problem-solving capabilities specific to downstream purification.
• Demonstrating strong interpersonal skills for working in cross-functional teams.
• Demonstrate strong communication skills, both oral and written.
• Technical writing expertise, including reports, study designs, protocols, and SOPs related to downstream purification.
• Demonstrate ability to participate in and facilitate decision-making.

• Process development and validation experience.
• Process and equipment knowledge of cell culture or purification functions.
• Thorough understanding of GMP requirements for a large-scale manufacturing facility

• B.S. or M.S. in Biology, Biochemistry, Engineering or related science with a minimum of 2-7 years’ experience in a cGMP biopharmaceutical manufacturing environment.
• Position is a banded position; education and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be…