Scientist, Bioanalytical Assay Development
- Employer
- Surrozen, Inc.
- Location
- South San Francisco, California
- Start date
- Jun 3, 2023
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Surrozen is recruiting a Bioanalytical Assay Development Scientist to develop and qualify assays to support biotherapeutic drug development. She or he will also contribute to assay transfer to CRO’s to enable validated sample bioanalysis of nonclinical and clinical studies. In addition, the candidate will contribute to developing assays to support discovery and preclinical studies conducted in-house. The preferred candidate will bring enthusiasm, intellectual curiosity, scientific integrity, and a desire to understand biological principles of developing regenerative medicine therapeutics.
Responsibilities:
- Work with project teams to devise the bioanalytical strategy for lead candidate molecules to support translation from discovery-stage to clinical-stage therapeutics
- Lead the bioanalytical strategy for multiple programs to achieve required milestones
- Develop and qualify fit-for-purpose PK, PD, and immunogenicity assays that meet the needs of the program and perform subsequent analysis of study samples
- Summarize bioanalytical results, develop work processes, and write technical reports in support of
- Manage method transfer and outsourcing efforts to allow timely bioanalytical support for research and development activities
- Participate in regular cross-functional team meetings and effectively communicate key BA strategies and results business development activities and regulatory filings
- PhD in Biology, Biochemistry, Pharmacology, Immunology, or equivalent with minimum 2 years post-degree of relevant industry experience
- Master degree or Bachelor degree with relevant industry experience of 2-5+ years
- Has experience developing and/or validating pharmacokinetic, immunogenicity, and biomarker assays for protein and/or antibody-based therapeutics across the lifecycle of drug development
- Has experience developing assays for cell and/or tissue matrices, in addition to serum matrix
- Thoroughly understands the FDA’s and EMA’s regulatory guidance related to bioanalytical assays
- Has experience managing CRO’s, or experience working with assays in a GLP environment
- Highly desired but not required: successful regulatory filings for antibody-based therapeutics
- Highly desired but not required: direct experience with bispecific antibodies or fusion proteins
- Highly desired but not required: experience with cell-based assays to support mechanism of action studies
We are an Equal Opportunity Employer offering a competitive salary and benefits
Company
Repair. Restore. Renew
Surrozen is a biotechnology company focused on discovering and developing novel regenerative medicines with a focus on unlocking the powerful self-renewal properties of the body through specific control of the Wnt signaling pathway. Surrozen is at pre-clinical stage, and anticipates its first clinical trials will be underway in 2022. Surrozen (SRZN) became publicly traded in August of 2021.
Culture
Our inclusive and pioneering culture creates a sense of belonging, impact, adventure and fun. Join us and Collaborate, Lead, Innovate Motivate and be Brave, Open and Nurturing at Surrozen!
Total Rewards
Surrozen offers a competitive total rewards package that includes:
- Health and welfare benefits
- Generous vacation, sick leave, and company paid holidays
- 401k match
- Company sponsored events, adventures and weekly lunches
- Bring your dog to work Fridays
- Website
- http://surrozen.com/
- Phone
- 650-475-2820
- Location
-
171 Oyster Point Boulevard
Suite 400
South San Francisco
California
94080
United States
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