BioSpace
Senior Scientist 1, Biophysical Characterization
BioSpace, San Rafael, California, United States, 94911
Senior Scientist 1, Biophysical Characterization
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. With our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science.
Key Responsibilities
Strategic Leadership in Biophysical Characterization
Lead biophysical characterization strategies for protein-based therapeutics (enzymes, antibodies, fusion proteins) and, as appropriate, other modalities such as nanoparticles and/or small molecules.
Apply bioconjugation chemistry expertise to optimize critical product attributes such as half‑life, specificity, and developability.
Assay Development & Innovation
Develop, optimize, and validate fit‑for‑purpose and high‑throughput assays to assess higher‑order structure, aggregation, stability, and binding interactions.
For bioconjugates, evaluate conjugation efficiency, site occupancy, DAR/DPR, linker/payload stability, degradation profiles, and serum/matrix stability.
Deliver well‑documented, phase‑appropriate analytical packages suitable for internal or CRO execution (development → qualification → transfer).
Cross‑Functional Collaboration
Partner with Discovery, Therapeutic Development, Analytical Sciences, Protein Engineering, Formulation, and Regulatory teams to integrate biophysical insights and support decision‑making at key development milestones.
Technology Transfer & External Partnerships
Lead technology transfer of assays and workflows to Analytical Sciences or external partners (CROs/CDMOs), ensuring SOP completeness, acceptance criteria, comparability plans, and data integrity standards.
Scientific Innovation & External Engagement
Stay current on bioconjugation and analytical biophysics innovations (e.g., mass photometry, HDX‑MS, native/denaturing MS for DAR and site occupancy, FcRn assays).
Evaluate and implement emerging platforms to strengthen data quality and reduce program risk.
Regulatory Support
Prepare analytical reports and datasets supporting IND/CTA submissions.
Contribute to comparability assessments and respond to health authority queries in collaboration with CMC and Quality.
Mentorship & Culture Building
Act as a player‑coach, mentoring junior scientists, maintaining high data integrity standards, and promoting a culture of excellence, innovation, and accountability.
Qualifications
Education:
Ph.D. in Biophysics, Biochemistry, Pharmaceutical Sciences, or Chemical/Biomedical Engineering preferred.
M.S. or B.S. with significant industry experience will be considered.
Experience:
Ph.D. with 6+ years, M.S. with 10+ years, or B.S. with 12+ years of relevant experience in biophysical and analytical characterization of biologics.
Proven success with therapeutic protein conjugates (enzymes, antibodies, fusion proteins). Experience with small‑molecule or nanoparticle conjugates is an advantage.
Technical Expertise:
Working knowledge or hands‑on experience in at least one or two methods per category:
Size/Assembly: SEC‑MALS, FFF‑MALS, AUC, DLS, Mass Photometry
Structure/Stability: DSC, DSF, CD, FTIR, HDX‑MS (preferred)
Binding/Mechanism: SPR, BLI, ITC, MST
Chromatography/Charge/Identity: HIC, IEX, RP‑HPLC, CE‑SDS, cIEF, LC‑MS (intact mass, peptide mapping; native/denaturing for DAR/site occupancy)
Conjugation Analytics: DAR/DPR analysis, linker/payload stability, forced degradation, serum/matrix stability
Regulatory & CMC:
Experience contributing to IND/CTA filings and supporting method lifecycle management for complex biologics and conjugates.
Core Competencies
Strong experimental design, quantitative analysis, and problem‑solving skills
Clear written and verbal communication
Ability to lead and collaborate within cross‑functional, matrixed teams
Experience managing CRO/CDMO deliverables
Preferred Qualifications
Experience establishing release and stability testing panels for biologics or conjugates
Demonstrated success transferring analytical methods to/from CROs/CDMOs, including full documentation and comparability packages
Familiarity with regulatory submissions and agency interactions for bioconjugates or ADCs
Evidence of scientific innovation, such as peer‑reviewed publications, patents, or conference presentations
Note: This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#J-18808-Ljbffr
Key Responsibilities
Strategic Leadership in Biophysical Characterization
Lead biophysical characterization strategies for protein-based therapeutics (enzymes, antibodies, fusion proteins) and, as appropriate, other modalities such as nanoparticles and/or small molecules.
Apply bioconjugation chemistry expertise to optimize critical product attributes such as half‑life, specificity, and developability.
Assay Development & Innovation
Develop, optimize, and validate fit‑for‑purpose and high‑throughput assays to assess higher‑order structure, aggregation, stability, and binding interactions.
For bioconjugates, evaluate conjugation efficiency, site occupancy, DAR/DPR, linker/payload stability, degradation profiles, and serum/matrix stability.
Deliver well‑documented, phase‑appropriate analytical packages suitable for internal or CRO execution (development → qualification → transfer).
Cross‑Functional Collaboration
Partner with Discovery, Therapeutic Development, Analytical Sciences, Protein Engineering, Formulation, and Regulatory teams to integrate biophysical insights and support decision‑making at key development milestones.
Technology Transfer & External Partnerships
Lead technology transfer of assays and workflows to Analytical Sciences or external partners (CROs/CDMOs), ensuring SOP completeness, acceptance criteria, comparability plans, and data integrity standards.
Scientific Innovation & External Engagement
Stay current on bioconjugation and analytical biophysics innovations (e.g., mass photometry, HDX‑MS, native/denaturing MS for DAR and site occupancy, FcRn assays).
Evaluate and implement emerging platforms to strengthen data quality and reduce program risk.
Regulatory Support
Prepare analytical reports and datasets supporting IND/CTA submissions.
Contribute to comparability assessments and respond to health authority queries in collaboration with CMC and Quality.
Mentorship & Culture Building
Act as a player‑coach, mentoring junior scientists, maintaining high data integrity standards, and promoting a culture of excellence, innovation, and accountability.
Qualifications
Education:
Ph.D. in Biophysics, Biochemistry, Pharmaceutical Sciences, or Chemical/Biomedical Engineering preferred.
M.S. or B.S. with significant industry experience will be considered.
Experience:
Ph.D. with 6+ years, M.S. with 10+ years, or B.S. with 12+ years of relevant experience in biophysical and analytical characterization of biologics.
Proven success with therapeutic protein conjugates (enzymes, antibodies, fusion proteins). Experience with small‑molecule or nanoparticle conjugates is an advantage.
Technical Expertise:
Working knowledge or hands‑on experience in at least one or two methods per category:
Size/Assembly: SEC‑MALS, FFF‑MALS, AUC, DLS, Mass Photometry
Structure/Stability: DSC, DSF, CD, FTIR, HDX‑MS (preferred)
Binding/Mechanism: SPR, BLI, ITC, MST
Chromatography/Charge/Identity: HIC, IEX, RP‑HPLC, CE‑SDS, cIEF, LC‑MS (intact mass, peptide mapping; native/denaturing for DAR/site occupancy)
Conjugation Analytics: DAR/DPR analysis, linker/payload stability, forced degradation, serum/matrix stability
Regulatory & CMC:
Experience contributing to IND/CTA filings and supporting method lifecycle management for complex biologics and conjugates.
Core Competencies
Strong experimental design, quantitative analysis, and problem‑solving skills
Clear written and verbal communication
Ability to lead and collaborate within cross‑functional, matrixed teams
Experience managing CRO/CDMO deliverables
Preferred Qualifications
Experience establishing release and stability testing panels for biologics or conjugates
Demonstrated success transferring analytical methods to/from CROs/CDMOs, including full documentation and comparability packages
Familiarity with regulatory submissions and agency interactions for bioconjugates or ADCs
Evidence of scientific innovation, such as peer‑reviewed publications, patents, or conference presentations
Note: This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#J-18808-Ljbffr