Production Scientist (Column Packer)

Astrea Bioseparations Ltd is a global bioseparations company specializing in the research, development and manufacture of advanced bioseparation products including chromatography adsorbents and columns. A wholly owned subsidiary of Gamma Biosciences, Astrea Bioseparations has R&D laboratories in Cambridge, UK and manufacturing facilities on the Isle of Man, British Isles and Stoughton, Massachusetts, making the company one of the largest volume affinity adsorbent manufacturers in the world.

Astrea Bioseparations is honoured to support the biopharmaceutical industry with products and services that help bring lifesaving and improving medicines to market. Regardless of process scale, we are ready to build Purity by Design into each process to ensure quality and speed to market.

The company is now entering an exciting period of growth as we work towards enabling our customers to bring advanced therapies to market using state-of-the-art-purification nanofiber-based technology.

Role

Support Astrea in meeting its business objectives by ensuring that the Production department’s manufacturing and quality goals are met.

• Manufacture of established and development products
• Process/Product optimisation
• Contribute to team effort.

Principle Responsibilities

Manufacture of established and development products:

• Assembly and packaging of prepared SNAP and Evolve Process Columns
• Timely and accurate completion/review of production documentation and maintenance of laboratory records/notebooks
• Understand fully the components and operations of Astrea’s SNAP and Evolve Columns
• Analysis of the SNAP and Evolve Column performance
• Create column packing method forms
• Must understand the process of liquid chromatography
• Understand the workings of AKTA Purifier systems, including hardware and software
• Cleaning, testing and assembly of the multi-part housing units in a classified cleanroom environment
• Buffer and media preparation, as well as equipment and component cleaning and preparation
• Understand the formulas that are derived from performing chromatography, and use these results to perform column packing in accordance with client and Manufacturer’s specifications
• Order supplies and equipment as required to perform column packing and lab operations.

Other accountabilities:

• Be responsible for documenting costing for column packing operations to help management better understand how to price the service
• Execution of validation protocols
• Coordinate with suppliers and Customers as required to perform column packing services
• Work in compliance with all aspects of Astrea’s IS0 Quality Management System
• Maintain a safe working environment and follow all site safety procedures
• Organise the la
• Organise all chemicals and substances in the lab and generate a plan to create safety procedures to handle and deal with them including personal safety and disposal.
• Other tasks as assigned by management.

Qualifications, knowledge and experience

• BSc. in any science field (preferably chemistry).
• Experience working in a classified cleanroom, and knowledge of GMP/IS0/document-controlled processes would be beneficial.
• Demonstrable experience in process improvement methodologies and their implementation.

Working conditions

• Laboratory based; long hours standing
• Required to wear PPE
• Desk based 20% laboratory based 80% manual operations

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Canton, MA 02021: Reliably commute or planning to relocate before starting work (Required)

Language:

• English (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: In person