Scientist I-Protein Characterization

Delivers critical analytical characterization support across upstream, downstream, and bioconjugation groups to drive bioreactor, purification, and conjugation process development through verification, development, and conformance runs. Formulates experimental plans, technical reports, and scale-down models essential for client IND and BLA regulatory submissions. Collaborates closely with the cross-functional MSAT-PD team to resolve complex technical deviations and evaluate long-term protein formulation stability.

location: Fort Lauderdale, Florida
job type: Permanent
work hours: 9 to 5
education: Bachelors

responsibilities:
Specific Duties:

- Regulatory & Compliance: Applied deep working knowledge of FDA, EMA, and ICH guidelines to ensure all activities align with rigorous GLP and cGMP compliance standards.

- Analytical Characterization: Executed complex biochemical and biophysical characterization assays, including ELISA, CE-SDS, icIEF, HPLC, Western Blot, BCA, and cell-based methods, to analyze the primary, secondary, tertiary, and quaternary structures of recombinant proteins and monoclonal antibodies (mAbs).

- Formulation & Stability: Partnered with cross-functional teams to design and execute complex data analysis for the formulation development and long-term stability assessments of therapeutic proteins.

- Operational Readiness: Established robust Bills of Materials (BOM) for novel processes while managing laboratory inventories, equipment maintenance, and up-to-date supply procurement.

- Controlled Substances: Demonstrated strict adherence to safety and compliance protocols when handling and processing controlled substance molecules.

- Cross-Functional Collaboration: Collaborated effectively as a technical liaison across Upstream (Cell Culture), Downstream (Purification), Bioconjugation, Quality, Regulatory, and Manufacturing teams to resolve process deviations and drive project timelines.

- Data Integrity: Maintained meticulous, compliant records of all laboratory execution and data analysis within official laboratory notebooks.

- Ability to perform complex data analysis.

- Effectively interact and assist other groups within the Development groups (Cell Culture, Protein Purification, and Bio-Conjugation) and the Quality/Regulatory and Manufacturing groups on process-related matters.

- Must be able to manage multiple projects.

- Maintain an up-to-date inventory of lab supplies and order materials as necessary.

qualifications:

• Masters of Science (MS): in protein chemistry, biochemistry or organic chemistry
• 3 + years relevant laboratory experience in antibody/protein characterization as it pertains to purification and bio-conjugation processes and development, particularly in the areas of immunology, molecular and cell biology, and protein chemistry.
• Bachelor of Science (BS): protein chemistry, biochemistry or organic chemistry
• 5+ years of relevant laboratory experience in Organic Synthesis/Bioconjugation, and bio-conjugation processes and development.

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skills: Cell Cultures

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.