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Manufacturing Associate II
2525 223rd Street Southeast, Bothell, WA 98021 US
Job Description
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.
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.
Education:
? BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) with a minimum of 2 years’ experience.
Pay Rate Range: $25-38/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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