Scientist Biologics Developability

Description

• The Biologics CMC Developability team is an integral part of the Biologics CMC Drug Product Development organization. The team is responsible for identifying biophysical and chemical liabilities in discovery-stage biologic drug candidates to guide lead selection and characterizing key CMC attributes important for biologic drug development.
• We are seeking a Scientist III to support biologic drug product development through advanced analytical characterization of therapeutic biologic molecules. This role focuses on LC-MS and chromatography-based analytical characterization, preparation of analytical packages for downstream stakeholders, and assessment of critical quality attributes and molecular characteristics of biologic candidates. The successful candidate will work in a collaborative laboratory environment, generate high-quality analytical data, and contribute to development-stage biologics programs using cutting-edge analytical techniques.

Top 3 Required Skills

• Biologics characterization using Liquid Chromatography–Mass Spectrometry (LC-MS).
• Liquid chromatography methods (SEC, IEX, RP-HPLC).
• BS/MS/PhD in Biochemistry, Biology, Chemistry (or equivalent) with relevant biopharmaceutical industry experience.
• Must Haves
• BS or MS in Biochemistry, Biology, Chemistry, or equivalent (Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline), with:
• 3–5 years of biopharmaceutical industry experience (Bachelor's), OR
• 1–2 years of biopharmaceutical industry experience (Master's), OR
• PhD with 0+ years of biopharmaceutical industry experience.
• Hands-on experience with protein mass spectrometry, including:
• Subunit analysis
• Peptide mapping
• Disulfide mapping
• Strong experience with LC-MS-based characterization of biologic molecules.
• Experience with liquid chromatography methods commonly used for biologic protein characterization, including:
• Size Exclusion Chromatography (SEC)
• Ion Exchange Chromatography (IEX)
• Reverse Phase HPLC (RP-HPLC)
• Experience with LC-MS data processing and analysis.
• Experience supporting biologics analytical characterization in a pharmaceutical or biopharmaceutical industry environment.
• Experience preparing analytical packages and reports for downstream stakeholders.
• Proficiency in MS Excel and GraphPad.
• Ability to independently execute experiments, analyze data, and deliver high-quality scientific results.
• Strong written and verbal communication skills.
• Excellent collaboration and teamwork skills.

Day to Day

• Perform in-depth LC-MS-based characterization of therapeutic biologic molecules and evaluate post-translational modifications (PTMs).
• Conduct liquid chromatography-based characterization using Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), and Reverse Phase HPLC (RP-HPLC).
• Execute experimental protocols, collect results, and perform data analysis independently.
• Perform chromatography-based analytical testing to support biologics development programs.
• Prepare analytical packages for downstream stakeholders, including Analytical Research & Development (ARD) and Product Research & Development (PRD).
• Analyze experimental data and prepare scientific reports and presentations.
• Maintain electronic laboratory notebooks, protocols, and scientific documentation.
• Support operation, maintenance, calibration of laboratory equipment, and routine laboratory operations.
• Collaborate with cross-functional research and development teams to achieve project goals.
• Build strong relationships across teams supporting biologics development.
• Follow laboratory safety procedures, corporate code of conduct, and documentation compliance standards.

Plusses

• Experience with Waters Empower software.
• Experience with Protein Metrics software.
• Experience with liquid handling robotic systems and workflow automation.
• Experience with Hamilton or Tecan liquid handling platforms.
• Experience supporting biologic drug development and CMC activities.
• Demonstrated record of independent thinking, creativity, scientific innovation, publications, or technical achievements.
• Strong problem-solving and experimental troubleshooting skills.
• Experience working in downstream biopharmaceutical development environments.

Ideal Candidate

• Strong biologics analytical characterization experience.
• Hands-on expertise with LC-MS and chromatography-based analytical workflows.
• Experience supporting development-stage biologics or Biologics CMC programs.
• Strong industry experience preferred over primarily academic experience.
• Self-motivated with the ability to independently plan and execute experiments.
• Comfortable performing routine analytical laboratory workflows with minimal supervision.

Key Screening

• Biologics analytical characterization experience.
• LC-MS / Mass Spectrometry experience.
• Liquid Chromatography experience.
• Size Exclusion Chromatography (SEC) experience.
• Ion Exchange Chromatography (IEX) experience.
• Reverse Phase HPLC (RP-HPLC) experience.
• Peptide Mapping experience.
• Protein Mass Spectrometry experience.
• Experience with Waters Empower.
• Experience with Protein Metrics.
• GraphPad and MS Excel proficiency.
• Experience supporting biologics characterization workflows.
• Downstream biopharmaceutical development experience.
• Experience preparing analytical packages for downstream stakeholders.
• Experience limited to small molecules without biologics exposure.
• No liquid chromatography experience.
• Primarily academic experience without relevant biopharmaceutical industry experience.
• PhD candidates with significantly more than approximately 2 years of post-PhD industry experience.
• Master's candidates with approximately 12+ years of experience who may be overqualified.