Manager - Manufacturing (FT) Job at Access to Advanced Health Institute
Manager - Manufacturing (Formulation and fill/finish)
Access to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it’s unfair that where a person lives or how much money they make dictates their access to life-changing medicine. We’re looking for people who want to join us in increasing accessibility to tools that harness the immune system and allow a healthy life, free of illness and disease, regardless of geography or socio-economic status - from compassion and collaboration come change.
Access to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it’s unfair that where a person lives or how much money they make dictates their access to life-changing medicine. We’re looking for people who want to join us in increasing accessibility to tools that harness the immune system and allow a healthy life, free of illness and disease, regardless of geography or socio-economic status - from compassion and collaboration come change.
We will serve as a center for innovation and collaboration in vaccine and cancer immunotherapy research and development, early-phase GMP manufacturing, and training the next generation of scientists and manufacturing teams to achieve our mission. This is where the high-quality science of an academic research organization and the product-development capabilities of a biotech company meet.
Summary:
This position is responsible for planning, scheduling, and managing AAHI production processes for adjuvant formulations, RNA vaccines, and other GMP products. The Manager supervises Manufacturing Associates in job performance.
Responsibilities:
- Formulation and fill/finish of adjuvants and RNA formulations for clinical trials.
- Maintenance of cGMP manufacturing facility, including cleaning of cleanrooms.
- Assist in developing and executing manufacturing and facility validations.
- Write and/or revise cGMP documents related to production and materials management (SOPs, CAPA's, IQ/OQ/PQ's, etc.).
- Remain on-call after hours (on rotating basis) to monitor and respond to equipment alarms as needed.
- Work with clients, partners, upper management and peripheral departments to schedule manufacturing runs.
- Manage MFG department employees, equipment and facilities.
- Train new operators working in GMP manufacturing.
- Evaluate and implement manufacturing strategies for new products.
- Implement process improvements and corrective actions.
- This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.
Requirements:
- BA/BS or equivalent in a biological science, chemistry, or related discipline, and 5-10 years’ experience in cGMP manufacturing.
- Experience with fill and finish operations for small volume parenterals, clinical or commercial product.
- Experience with cGMP qualifications/validations (IQ/OQ/PQ) of facilities, equipment, and manufacturing processes.
- Experience with cleaning and sterilization methods and validations (i.e. automated and manual wash methods, clean in place, steam sterilization, depyrogenation, etc.).
- Experience with pharmaceutical inventory/supply chain management.
- Experience with shipping GMP products and shipping regulations.
- Experience with GMP facility management.
- Working knowledge of FDA GMP regulations and industry standards for production of sterile drug products.
- Must be a self-starter, able to work under minimal supervision, and willing to perform hands-on operations of production activities.
- Excellent communications, both written and verbal.
- Proven history of problem-solving and critical thinking.
- Strong attention to detail.
Benefits:
We offer a comprehensive compensation plan which includes:
- Medical, Dental, Vision
- Up to 6 weeks' Vacation & Sick pay
- Group Life, AD&D, Short & Long-term disability, Hospital Indemnity, Accident
- Flexible Spending Accounts (HSA and Dependent Care)
- Matching 401(k) Retirement Plan
- Commuter benefits
- Employee Assistance Plan (EAP)
- Flexible work schedule
- Mindfullness/Fitness App Subscription
- Voluntary & Lifestyle Benefits
Vaccination Requirement:
Due to the threat of more infectious and deadly COVID-19 variant strains emerging, we recently announced a new mandatory vaccination policy requiring our employees to be fully vaccinated against COVID-19 as a condition of employment. We will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, AAHI joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of employees and the community.
We do not discriminate. We are an equal opportunity employer and are committed to inclusion and encourage everyone to bring their full selves to work. We are an E-Verify Employer.
About Access to Advanced Health Institute:
AAHI is a nonprofit biotech research institute, bringing together the best experts, technologies, and platforms to create accessible, high-quality products and solutions for harnessing the immune system to alleviate disease. We are building a world where every person has access to tools that harness their immune system and allow them to live a healthy life, free of illness and disease.
Please Note :
blog.nvalabs.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blog.nvalabs.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.