Head of Bioanalytical Sciences

2 weeks ago

Jackson, Mississippi, United States Vera Therapeutics, Inc Full time

Position Title:
Director, Bioanalytical Sciences

Location:
Remote

Company Overview:

Vera Therapeutics (Nasdaq:
VERA) is a pioneering biotechnology firm dedicated to developing innovative therapies for severe immunological disorders.

Our objective is to enhance treatment options that address the underlying causes of immunologic diseases, thereby transforming the standard of care for patients.

Our flagship product candidate, atacicept, is a fully humanized fusion protein designed for self-administration at home via a weekly subcutaneous injection, effectively inhibiting both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL).

Additionally, we are advancing MAU868, a monoclonal antibody aimed at neutralizing BK Virus infections.

For further details, please visit:
.

Our core values are fundamental to our culture and influence every aspect of our operations—from recruiting exceptional talent to collaboratively pursuing our mission.


Role Overview:
We are in search of a Director, Bioanalytical Sciences, to become part of a skilled, dynamic, and collaborative team.

This role will report to the Executive Director of Analytical Sciences and will oversee all facets of bioanalytical assay development for our antibody and fusion protein products.

The successful candidate will be responsible for establishing robust bioanalytical methodologies to support clinical trials and facilitate global regulatory approvals.

Key Responsibilities:


Collaborate with the clinical research team to design and implement bioanalytical studies (e.g., PK, ADA, and other biomarkers) that support clinical trials.

Engage with Contract Research Organizations (CROs) to develop, validate, and uphold bioanalytical methods that support Vera's clinical initiatives.
Review validation protocols, testing procedures, raw data, and technical reports to ensure scientific accuracy and adherence to GLPs/GDPs.
Work closely with Clinical Operations, Clinical Data Management, and Biostatistics to guarantee the timely collection of high-quality data.
Draft memos, protocols, reports, and analytical sections for regulatory submissions.
Lead the selection of CROs and oversee timelines, budgets, shipments, and inventory management.
Assist with quality audits, deviations, and troubleshooting activities.

Required Qualifications:


PhD in Chemistry, Biochemistry, or a related field with at least 8 years of experience in biopharmaceuticals, or a Master's/Bachelor's degree in Chemistry, Biochemistry, or a related field with a minimum of 10 years of experience.

Proven expertise in designing and managing bioanalytical studies for protein therapeutics.
Experience in developing, validating, troubleshooting, and maintaining bioanalytical methods for recombinant protein therapeutics.
Demonstrated proficiency in establishing assays for PK, ADA, Nab, and biomarkers.
Strong technical knowledge in ligand-binding assays, LC-MS, and other bioanalytical techniques.
Experience in authoring and reviewing methods, validation protocols, and regulatory submissions.
Expertise in interpreting and applying international regulatory guidelines for bioanalytical methods.
Experience in managing CROs is essential.
Familiarity with recombinant protein characterization is highly desirable.
Exceptional interpersonal skills and a proven ability to thrive in a team-oriented environment.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to equitable compensation practices. The anticipated base pay range for this role is $196,000 - $225,000, with the exact base pay depending on various factors, including the candidate's qualifications, skills, and experience.
At Vera, base pay is just one component of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also provides a variety of benefits, including medical, dental, and vision insurance, 401k matching, and flexible time off.

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