Associate II, Manufacturing

Associate II, Manufacturing

Location: Bothell, WA

Duration: 3-4 Months with possible extension

Description:

Duties :

The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations.

Key Role And Responsibilities:

Execute the Day-to-Day Manufacturing Processing

Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.

Adhere to the current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs).

Escalate manufacturing operations issues to management and quality assurance in a timely manner.

Maintain production facilities at a high standard of cleanliness and organization.

Perform equipment maintenance and calibrations as required.

Complete and review GMP documentation in a timely manner.

Maintain appropriate level of training for assigned responsibilities.

Assist with inventory management of supplies in the manufacturing facility.

Assist with daily tasks and support manufacturing. Collaborate Effectively

Be a team player, offer assistance, and respond well to requests for help from team members.

Use strong communication and build relationships.

Demonstrate technical acumen, operational understanding, and GMP compliance.

Support operational excellence initiatives.

Support a culture of safety and GMP compliance.

Identify opportunities for continuous improvement.

Skills:

A Minimum of 2 years' experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.

Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).

Experience with electronic systems such as MES and ERP.

Role Description Knowledge, Skills And Abilities:

Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.

Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.

Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.

The desire and ability to work in a fast-paced, start-up environment.

Education :

BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) with a minimum of 2 years' experience.Our Client, a Clinical-Stage Cell Therapy company, is looking for an Associate II, Manufacturing for their Bothell, WA location.

Responsibilities:

• Execute the Day-to-Day Manufacturing Processing
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Adhere to the current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs).
• Escalate manufacturing operations issues to management and quality assurance in a timely manner.
• Maintain production facilities at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Assist with inventory management of supplies in the manufacturing facility.
• Assist with daily tasks and support manufacturing. Collaborate Effectively
• Be a team player, offer assistance, and respond well to requests for help from team members.
• Use strong communication and build relationships.
• Demonstrate technical acumen, operational understanding, and GMP compliance.
• Support operational excellence initiatives.
• Support a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.

Requirements:

• A Minimum of 2 years' experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
• Experience with electronic systems such as MES and ERP.
• Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
• Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
• Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
• The desire and ability to work in a fast-paced, start-up environment.
• BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) with a minimum of 2 years' experience.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities