Associate II, Manufacturing

TalentBurst, Inc.

Bothell, WA

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JOB DETAILS

SALARY

$35–$35 Per Hour

SKILLS

Cell Cultures, Change Management, Communication Skills, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Drug Products, Equipment Maintenance/Repair, Fermentation, GMP (Good Manufacturing Practices), Interpersonal Skills, Inventory Management, Manufacturing, Manufacturing Operations, Manufacturing Operations Management, Manufacturing Requirements, Operational Support, Physical Demands, Quality Assurance, Quality Management, Safety Compliance, Standard Operating Procedures (SOP), Startup, Team Player, Testing, Time Management, Visual Information

LOCATION

Bothell, WA

POSTED

1 day ago

Title: Associate II, Manufacturing
Location: Bothell, WA
Duration: 6+ Months

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.

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.

PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and drug product. A vision test will be required. Use of corrective lenses is acceptable.
Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns.
Work inside the processing facility for extended hours, and gowning into and out of Grade A and B environments.

SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

About the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/

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