Manufacturing Associate II

Pride Health is seeking a Manufacturing Associate II for a company developing next-generation T-cell reprogramming technologies.

Job Title: Manufacturing Associate II

Location: Bothell, WA 98021

Job Type: Contract

Length: 12 Months

Hours:

Front Half Schedule - Sunday-Wednesday 7am-5:30pm - 2 openings

Back Half Schedule - Wednesday-Saturday 9am-5:30pm - 3 openings (however this shift doesn't exist yet, new hires will initially work 7am-5:30pm, once all new team members are trained and they are ready to split into two shifts they plan to implement the new hours within the next 2-3 months)

Pay Rate: $33.00 - $38.46 per hour

Overview:

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

This role will work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations..

KEY ROLE AND RESPONSIBILITIES:

• Startup Facility and Operations
• Work collaboratively with the MSAT, Quality, Process Sciences and Vector Sciences on all aspects of facility qualification and start-up.
• Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations. Execute the Day-to-Day Manufacturing Processing
• Assist in development and implementation of GMP procedures and policies related to Manufacturing Operations.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Maintain production facilities at a high standard of cleanliness and organization, perform equipment maintenance and calibrations as required, and complete and review GMP documentation in a timely manner.
• Maintain appropriate level of training for assigned responsibilities.
• Work with TechOps teams to execute technology transfers and capacity building projects.
• Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.
• Collaborate Effectively
• Use strong communication and teamwork skills to build relationships across the manufacturing site.
• Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
• Support operational excellence initiatives, and the implementation of new technologies and systems.
• Ensure a strong culture in safety and GMP compliance

Requirements:

• 0 - 2 years of 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).
• BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)
• A Minimum of 4 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.
• BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) with a minimum of 5 years' experience
• MA II candidates must have 2–4 years of experience.
• Cell therapy experience is ideal, but we are open to candidates with any GMP manufacturing background.
• 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 product. A vision test may 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.

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.

Benefits that Pride Health offers:

Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Apply Today! If you are interested in the position, please email your resume to rob.vanriet@pridehealth.com for immediate consideration.