- Apply a fundamental understanding of mammalian cell culture operations including single-use bioreactors and perfusion and harvest technologies to support technology transfer and scale-up of clinical/commercial manufacturing processes.
- Apply a good understanding of engineering principles for scale up of cell culture unit operations from bench to manufacturing scale.
- Develop process knowledge and ownership.
- Provide floor support/person-in-plant for manufacturing activities during clinical and validation campaigns (travel may be required)
- Work with external vendors (CDMO) and provide leadership/guidance in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials.
- Experience with statistical Design of Experiments and/or Quality by Design.
- Experience with risk assessments (FMEA)
- Authors technical documents, including technical reports and protocols.
- Participate in cross functional teams and represent Upstream CMC
- B.S (M.S./ Ph.
- Experience with scaling up unit operations with an understanding of cGMP requirements, FDA, and ICH guidelines.
- Experience in communicating and presenting complex technical information to internal and external teams.
- Self-motivated, ability to muti-task, and a desire to acquire new technical skills.
- Flexibility to change project objectives and enthusiasm.
- Excellent written and verbal communication skills.
- Works well independently and in teams in a highly dynamic, cross-disciplinary environment.#LI-hybridAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Professional level position, with a compensation range of $100,000 - $115,000. Note that candidates must be located in WA state. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees' satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.
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Process Engineer - Seattle, United States - Alpine Immune Sciences, Inc.
Description
Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases.
Join usAlpine Immune Sciences is seeking a highly motivated individual to join the CMC team as a Process Engineer (Upstream).
This individual will be part of a team working to design and develop upstream processes that are robust, scalable, well characterized, and economical for clinical and commercial manufacturing.
The successful candidate should have experience in cell culture process development and/or scale up of cell culture manufacturing unit operations and will interact with Alpine's network of external CDMOs.
This is a Hybrid role that will be based out of our Seattle, WA office.Duties and responsibilities:
Qualifications:
We nurture Alpine's culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle.
Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy.
Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.
Exciting challenges lie ahead-guided by our core values, we'll meet these challenges. Join us
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