Associate Scientist/Scientist, Bioassay – Analytical Development

Description:

We are seeking an enthusiastic, goal-oriented scientist to join our Analytical Development team and develop, optimize, and implement analytical methods for novel therapeutic products, including monoclonal antibodies, bispecific antibodies, fusion proteins, and other biologics. This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package.

The role focuses on ELISA and cell-based bioassays supporting programs from early development through commercialization and product lifecycle management. The successful candidate will contribute to multiple projects supporting process development, formulation development, release testing, stability studies, and product characterization.

The position may be filled at the Associate Scientist or Scientist level, depending on relevant experience, technical expertise, and demonstrated independence.

Zylidac Bio LLC is a leading Contract Development and Manufacturing Organization specializing in the development and manufacturing of biologics, particularly antibodies. We are committed to delivering high-quality products and services that meet the evolving needs of our clients in the biopharmaceutical industry.

RESPONSIBILITIES:

• Develop, optimize, and perform ELISA and cell-based bioassays to characterize biologic therapeutics.
• Perform analytical testing to support process development, formulation development, release testing, stability studies, and product characterization.
• Support assay qualification, validation, and method transfer activities as needed.
• Analyze data, interpret results, identify trends, and troubleshoot assay performance.
• Maintain accurate documentation of experimental procedures, results, and conclusions in laboratory notebooks and analytical records.
• Present experimental results and scientific findings in team meetings and technical discussions.
• Collaborate across multidisciplinary teams to complete assigned work and meet project timelines.
• Contribute to the evaluation and implementation of new technologies, methods, and laboratory processes.
• Follow laboratory safety requirements and applicable quality systems, procedures, and regulatory requirements.
• Support laboratory operations, including instrument maintenance, reagent and sample management, and supply ordering.
• Contribute to technical documentation supporting quality and regulatory activities.
• Design and execute experiments, develop and troubleshoot assays, and own technical deliverables with increasing independence.

Requirements:

QUALIFICATIONS – SKILLS & REQUIREMENTS:

• Relevant laboratory experience in bioassay development, analytical development, or cell and molecular biology.
• Hands-on experience with ELISA, qPCR, cell-based assays, mammalian cell culture, and aseptic techniques, with preference for experience in host cell protein, leached Protein A, host cell DNA, and other bioassay/analytical methods.
• Experience working in accordance with GMP requirements, quality systems, and data integrity principles, with strong attention to data quality, accurate documentation, and compliance.
• Ability to execute experiments, analyze data, troubleshoot assays, and communicate findings, with independence appropriate to the position level.
• Strong organizational, time-management, verbal, and written communication skills.
• Ability to learn new technologies and adapt to changing project priorities.

PREFERRED QUALIFICATIONS:

• Experience with assay qualification, validation, or method transfer.
• Experience working in a biopharmaceutical development or regulated laboratory environment.
• Experience with surface plasmon resonance (SPR).

EDUCATION & EXPERIENCE:

• Associate Scientist: Bachelor's degree with 4+ years, or Master's degree with 2+ years of relevant laboratory experience.
• Scientist: Bachelor's degree with 6+ years, Master's degree with 4+ years, or PhD with 0–2 years of relevant experience.
• Degree in Biochemistry, Molecular Biology, Cell Biology, Immunology, Biotechnology, or a related scientific discipline.