Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development
AbbVie · CA, US
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About the Role
AbbVie is seeking a Senior Scientist 1 to join the Bioassay Development team within CMC Biologics, Analytical Research & Development. This role is crucial for developing innovative medicines and solutions to address serious health issues and future medical challenges, particularly in immunology, oncology, neuroscience, and eye care.
Responsibilities
- Develop and optimize complex bioassays and target-binding potency assays for biotherapeutic development.
- Collaborate with analytical teams to understand structure/function relationships.
- Interact cross-functionally with Discovery, CMC, QC, and QA teams to support drug development and IND submissions.
- Qualify, validate, and transfer potency methods to external partners.
- Author technical documents, including test methods, protocols, and reports for regulatory submissions.
- Develop new techniques and explore novel approaches and technologies.
- Perform troubleshooting and optimization experiments.
- Present work to various cross-functional teams.
Requirements
- Must possess a MS degree in biology, biochemistry, cell/molecular biology, or a related field and 1 year of academic research or industry work experience as a development scientist.
- Must have 1 year of experience in developing binding potency assays (ELISA, TR-FRET, Octet, flow cytometry, other cell-based formats) to characterize and test protein therapeutics (monoclonal antibodies, ADCs, and/or other biologic modalities).
- Must have 1 year of experience in developing cell-based functional potency assays (cytotoxicity assays, reporter gene assays, proliferation assays, effector function activity assays (i.e. ADCC, CDC)) to characterize and test protein therapeutics (monoclonal antibodies, ADCs, and/or other biologic modalities).
- Must have 1 year of experience in performing cell-based target binding potency assays, non-cell-based target binding potency assays, and/or functional potency assays to characterize drug mechanism of action.
- Must have 1 year of experience using GraphPad PRISM, PLA, Softmax Pro, or similar data analysis software.
- Must have 1 year of experience optimizing and troubleshooting potency assays to improve performance and/or resolve performance issues.
- Must have 1 year of experience working in a matrixed organization within a cross-functional scientific environment within a (CMC) organization.
- Must have 1 year of experience authoring technical reports, drafting SOPs, writing CMC sections of regulatory filings, and giving scientific presentations to peers and management.
- Alternatively, a BS Degree in biology, biochemistry, cell/molecular biology, or a related field and 5 years of academic research or industry work experience as a development scientist is acceptable.
- If BS degree, must have 5 years of academic research or industry work experience in each of the listed areas (i) through (vii).
- Work experience may be gained concurrently.
- Combination of education, training, and work experience will be accepted.
Skills
- Bioassay development
- Potency assay development
- ELISA
- TR-FRET
- Octet
- Flow cytometry
- Cell-based assays
- Protein therapeutics characterization
- Monoclonal antibodies
- ADCs
- Biologic modalities
- Cytotoxicity assays
- Reporter gene assays
- Proliferation assays
- Effector function activity assays (ADCC, CDC)
- Drug mechanism of action
- GraphPad PRISM
- PLA
- Softmax Pro
- Data analysis
- Assay optimization
- Assay troubleshooting
- Matrixed organization
- Cross-functional scientific environment
- CMC organization
- Technical report writing
- SOP drafting
- Regulatory filing (CMC sections)
- Scientific presentations
Location
- South San Francisco, CA
Work Type
- Onsite (5 days per week)
Experience Level
- Senior Scientist
- 1 year post-MS experience
- 5 years post-BS experience
Education Level
- MS degree in biology, biochemistry, cell/molecular biology, or related field
- BS degree in biology, biochemistry, cell/molecular biology, or related field
Salary/Compensations
- $143,067.06 - $162,000.00 per year
Benefits
- Comprehensive package of benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Eligible to participate in short-term and long-term incentive programs
About the Company
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Equal Opportunity
- AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
- It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
- AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html