Senior Scientist, Bioanalytical Sciences
Job Description

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company’s pipeline is based on its platform technology addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio.

Desired Candidate Profile

We are seeking a highly motivated and experienced Senior Scientist to join the bioanalytical team. Qualified candidates must have extensive experience developing and implementing ligand binding (ELISA, MSD) assays for PK, ADA, and biomarkers that support preclinical and clinical programs. Cell-based assay experience is highly desirable. The ideal candidate will have experience at a level to provide scientific leadership to bioanalytical staff scientists in assay development, troubleshooting, and data interpretation. Broad experience with other technologies such as SPR (Biacore), and strategies for electronic data capture and laboratory automation is highly desirable. The candidate will work as part of broader, highly collaborative, interdisciplinary team in a fast-paced research & development environment. In addition, the candidate should have a solid understanding of the drug development paradigm from research through clinical development, experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of drug development programs. Experience with all aspects related to the bioanalytical flow from discovery to production including technology transfer and oversight of the Sponsor-CRO relationship is highly desirable.

Responsibilities

• Independently develop highly specific, sensitive, and accurate assays on MSD or other platforms for measuring biologic molecules in nonclinical and clinical matrices
• Optimize robust methods that will move from research to clinic assay status with a clear leaning toward long term program support and the regulatory requirements for BLA filing
• Identify and develop novel bioanalytical approaches to answer key scientific questions in support of the discovery and development of biologic drug candidates.
• Serves as the liaison between Annexon and the Contract Research Organization (CRO), providing oversight of assay transfer and continued support as the Subject Matter Expert (SME) for Annexon programs
• Assist with Vendor CRO management related to timelines, priorities, and approaches
• Monitor data quality in real time, eliminating gaps and/or issues that may surface downstream where course correction becomes difficult
• Assist with building an electronic document repository that holds all relevant information related to bioanalytical support used for clinical and nonclinical studies. This includes procedures, method validations, and sample analysis reports. Effort includes creating a map in terms of history, version, study use and method performance in preparation for BLA filing (Sections 2.6.6, 2.7.1, 5 and life cycle management).
• Maintain accurate and timely records of experimental designs, assay development, experimental results, data analysis, and interpretation.
• Author bioanalytical Test Methods, and Standard Operating Procedures for method qualifications, validations, study reports, reagent preparation, and equipment maintenance
• Generate and compile qualification and validation data to support use of the methods and set assay acceptance criteria

Key Qualifications

• PhD with 5-8 years of relevant experience or a BS or MS with 4-10 years industry experience
• Proven experience working with a variety of experimental technologies/platforms, developing novel methods and data analysis routines
• Ability to formulate scientifically sound approaches for bioanalytical support of Annexon programs
• Ability to thoroughly analyze data, summarize and drive interpretations
• Excellent problem-solving skills and ability to take on new challenges, with excellent personal and scientific communication skills.
• Ability to work well in a collaborative fast-paced team environment is essential.
• Experience with biomarker methods, biomarker fit for purpose validations and analysis
• Experience with GxP requirements related to bioanalytical support of biologics
• Experience developing assays on different platforms (MSD, Gyros, Luminex, etc.) with an understanding of the advantages and disadvantages of different platforms is expected
• Expected to work independently as well as collaboratively within a team, with excellent laboratory skills in immunological, cell-based and/or functional assays.
• Excellent oral and written communication skills
• Annexon’s Senior Scientist, Bioanalytical Sciences will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.