Biopharmaceutical Device Engineer
Alpine Immune Sciences is applying our platform discovery technology to bring innovative new therapies to people living with serious or life-threatening illnesses or conditions, such as cancer and autoimmune/inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
This role will lead the packaging development activities for multiple biologic projects at Alpine. The primary responsibility will be to design, develop, and implement packaging solutions from early phase biologics up to product launch. The candidate will work with cross-functional project team members that include Regulatory, QA/QC, Analytical, Process Development, and Manufacturing, etc. to implement packaging solutions that meet user needs, satisfy regulatory requirements, and fulfill the target product profile. The candidate will lead the evaluation and oversight of 3rd-party packaging suppliers and participate in tech transfer/new product introduction at drug product manufacturers. The candidate will support drug product process validation plans and provide oversight for shipping validation studies.
Primary Responsibilities:
- Apply design principles to develop and implement primary, secondary, and tertiary packaging solutions for sterile biologic solutions.
- Experience with biologics development, pre-filled syringes and autoinjectors.
- Develop proposal requests and participate in site selection of prefilled syringe filling lines, contribute to new product introduction and tech transfer activities for selected PFS filling sites.
- Oversee site packaging activities, including oversight of line trials to qualify primary, secondary, and tertiary packaging configurations.
- Provide technical support for root cause investigations for packaging related deviations or customer complaints. Coordinate with vendors and fill/finish sites to implement any necessary CAPAs.
- Establish and approve specifications related to packaging components.
- Establish phase appropriate approaches to shipping qualification and shipping validation including DS and DP (bulk and last mile shipments).
- Design product compatibility/functionality studies to guide the selection of new packaging configurations.
- Coordinate changes to packaging materials, including the evaluation of product quality, regulatory, and quality assessments. Design and oversee appropriate lab testing and line trials to support packaging changes.
- Oversee technical transfer activities from clinical to commercial DP manufacturing sites including from clinical packaging to commercial packaging sites.
- Effective communication skills and an established track record working within a multidisciplinary project team.
- Review and approve packaging labels and artwork.
- Develop and commercialise drug-device combination products and medical devices with a focus on drug device interactions
- Serve as primary container expert on technical development teams to provide the best-in-class containers and drug delivery devices for our medicines
- Forecast and plan resource demands for device development projects. Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices
- Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure drug containers and devices maintain the required level of performance throughout the life of the product
Preferred Experience, Special Skills, Knowledge:
- B.S. Degree in Packaging, Mechanical, or Materials Engineering or related engineering field of study >5 years of industry experience.
- Advanced degree in the Pharmaceutical, Biologics, or Medical Device fields of study and >3 years of industry experience.
- Experience with Design Control and Combination Products and familiarity with the regulatory requirements for biologic combination products.
- Apply your knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
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.
Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. 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.
We take care of our employees with competitive benefits package which includes premium medical, dental, and vision coverage for employees and their dependents, wellness programs, FSA and 401(k) plans. We believe that quality time outside the office is vital to our employees’ satisfaction at work. That’s why our flexible PTO plan encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
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.
As a condition of employment, Alpine requires that employees are up to date with COVID-19 vaccination. In order to be considered up to date, employees must have completed a primary series of a SARS-CoV-2 vaccine, followed by a booster dose, as recommended by the CDC. Employees can submit requests for medical or religious exemption so that Alpine can consider possible accommodations.
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 during the COVID pandemic. 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!