Senior Scientist I Analytical Development

BioSpace; South San Francisco (CA); On-site; USD 112,000 - 135,000; Full time

Benefits offered by this job

Stock options

Annual bonus

Health insurance 90% employee

Genentech bus & ferry

Cell phone stipend

Unlimited PTO

Onsite gym

Job summary

Alumis Inc. in South San Francisco, CA, is hiring a Sr. Scientist I of Analytical Development to bolster our small molecule CMC group.

You will support method development, validation, and transfer at CMOs/CTLs from preclinical through late-stage clinical development. The ideal candidate holds a BS/MS in chemistry or pharmaceutical sciences and 5+ years in analytical development, with hands-on experience in UPLC/HPLC, LC-MS, KF, and dissolution testing, plus CMOs/CTLs and regulatory knowledge

Qualifications

• BS/MS in chemistry or pharmaceutical sciences with at least 5 years in analytical development.
• Experience with analytical techniques for small drug molecules and oral solid formulations (UPLC/HPLC, LC-MS, KF, dissolution).
• Experience with CMOs/CTLs and regulatory requirements (ICH, cGMP).
• Strong communication and cross-functional collaboration.
• Ability to thrive in a fast-paced small company environment.

Responsibilities

• Support development, validation, and transfer of analytical methods for starting material, intermediates, drug substance and drug product at CMOs/CTLs.
• Execute and/or support in-house method development using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation from Phase 1 to late-stage development.
• Review CMO/CTL analytical data, protocols and reports.
• Trend stability and release data using statistical methods.
• Assist in investigations of non-conformance events at CMOs/CTLs.
• Collaborate with CMC team, QA and CMOs/CTLs to generate and approve documents.
• Communicate scientific results within cross-functional teams, orally and in writing.
• Author technical reports and regulatory submission documents (IND, IMPD, NDA).
• Assist in preparation of CMC documents for regulatory submissions.

Skills

Analytical development

Cross-functional teamwork

Regulatory awareness

Education

BS/MS in chemistry or pharmaceutical sciences

Tools

UPLC/HPLC

LC-MS

KF

Dissolution testing

IR

Particle size analysis

Solid-state characterization

Job description

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to support the analytical development and quality control activities from the preclinical phase through late-stage clinical development. Having analytical development expertise and experience in working with CMOs/CTLs, coupled with thorough understanding of the associated quality and regulatory awareness are key assets.

Responsibilities

• Support development, validation, and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs
• Execute and/or support the in-house method development activities using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation and techniques for Phase 1 to late-stage drug development
• Review CMO/CTL analytical data (in-process, release, and stability data), protocols and reports
• Trend stability and release data using statistical methods
• Assist in investigation for various non-conformance events at CMOs/CTLs
• Collaborate with CMC team, QA and CMOs/CTLs towards timely generation and approval of documents
• Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
• Author technical reports and documents in support of regulatory filing
• Assist in preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)

The Ideal Candidate

• BS/MS in chemistry or pharmaceutical sciences with 5+ years of experience in analytical development
• Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization techniques
• Proven track record in applying analytical techniques to solve challenging problems
• Experience in working with CMOs and CTLs
• Experience in early to late-stage drug development
• Strong organizational and communication skills
• Comfortable in a fast-paced small company environment and a strong team player
• Experience and knowledge in ICH, cGMP and regulatory requirements

This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.

The salary range for this position is $112,000 USD to $135,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other Benefits Include

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire to elevate, challenge and nurture one another along the way.

Alumis Inc. is an equal opportunity employer.