Associate Scientist

About the role

In this vital role you will contribute to our diverse early-stage portfolio projects that support different therapeutic modalities (bispecific/multispecific, fusion proteins, mAbs, ADCs and oligonucleotides). The candidate is expected to have hands-on experience in formulation development and stability characterization of large molecule drug candidates to assess their critical quality attributes supporting diverse therapeutic areas. The candidate will be responsible for drug product formulation and process development by providing scientific and technical expertise to advance the pre-pivotal portfolio.

Responsibilities

• Routinely plan, design, complete, and document stability studies related to FIH formulation development and fill/finish process development, in support of product commercialization.
• Responsible for design and execution of in-use compatibility studies for clinical to mimic clinical dose preparation and administration.
• Conduct stability studies to support liquid and lyophilized formulations; requires knowledge of ultrafiltration-diafiltration and other buffer exchange processes.
• Complete development of multi-modality protein drug formulations and analytical characterization of proteins via HPLC/UPLC/2-D HPLC methods, subvisible particle analysis, viscosity characterization, mass spectrometry, capillary electrophoresis, biophysical analysis.
• Actively participate and represent the drug product process development group in cross-functional project teams across the organization.
• Maintain continuous adherence to compliance and quality while meeting organizational goals and priorities.
• Author or review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions.
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs.
• Ensure meticulous data collection and documentation using electronic data capture systems.
• Work effectively in a matrixed team and present data cross-functionally.

Requirements

• Masters degree OR
• Bachelors degree and 2 years of Scientific experience OR
• Associates degree and 4 years of Scientific experience OR
• High school diploma / GED and 6 years of Scientific experience

Qualifications

• Masters degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, or related field with a minimum of 3+ years of industrial experience in pharmaceutical/biotechnology or related field.
• Understanding of physical/chemical stability of proteins and how process-related stress impacts product quality.
• Experience in antibody characterization, stability, and development of parenteral controlled-release delivery systems.
• Sophisticated understanding of predictive methods, protein stability and solubility.

Preferred Skills

• Preferred experience in biophysical analysis (light scattering, DSF, AUC, FFF), mass spectrometry (peptide mapping), high-throughput screening and data analytics.
• Preferred understanding of drug delivery and devices related to product development.
• Proficiency in statistical software (such as JMP), experience with data visualization tools or packages (Tableau or Spotfire).
• Strong independent problem-solving skills.
• Ability to learn and act on dynamic information at a rapid pace; hard-working and collaborative attitude.
• Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, cross-functional environment.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.