Analytical Development Senior Scientist

Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

Alpine Immune Sciences is seeking an experienced and dedicated Analytical Development Senior Scientist to support liquid chromatography (LC) and capillary electrophoresis (CE) based analysis and characterization of biotherapeutic proteins for CMC development. The ideal candidate has a strong Analytical Development background and is passionate about bringing new therapies to patients suffering from autoimmune and inflammatory diseases. Position responsibilities include execution of U/HPLC and CE-based test methods, development and qualification of drug substance and drug product release and stability methods, and management of external CDMO test method development, qualification, and validation. Opportunities exist for leadership roles, professional career development, and flexible hybrid work schedules.

Duties and responsibilities

•Analytical biochemistry subject matter expert and main point of contact for CMC related analytical testing requests

•U/HPLC and CE maintenance and operation

•Experimental design, analysis, and reporting of data in a lab notebook

•Characterization method development and suitability evaluation

•Development and qualification of LC and CE based methods for QC release and stability testing

•Apply industry standard analytical technologies and explore emerging technologies

•Management of CDMO Analytical Development related activities (e.g. method development, qualifications, and data review)

•Authoring of CMC related sections of regulatory filings (i.e., IND, IMPD, BLA)

•Education: PhD in Chemistry, Biochemistry, Engineering, or other relevant field with 2+yrs of relevant industry experience (BS with 7+yrs or MS with 5+yrs)

•Prior experience developing LC and CE-based methods for biopharmaceutical size, charge, and/or hydrophobic variants

•Mass spectrometry experience is a plus

•ELISA and/or cell-based bioassay experience is a plus

•Prior experience qualifying analytical methods for QC release and stability testing preferred

•Familiarity with industry, pharmacopeial, and regulatory guidance documents (e.g., ICH, USP, EP, FDA, EMA) preferred

•Experience authoring test methods, technical documents, external peer-reviewed publications, or regulatory documents

•Proficient at presenting complex technical data to cross-functional teams and external audiences

•Team oriented and collaborative experience working with internal functional area stakeholders (e.g. Research, Quality, Regulatory) and with external partners (e.g. CDMOs, CTLs, and partner organizations)

#LI-Hybrid

At 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 Technicial level position, with a compensation range of $135,000 - $147,000. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA. 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.

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.

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!