Senior Scientist – Biologics Analytical Development (CMC)

Integrated Resources, Inc ( IRI ); United States; On-site; USD 110,000 - 185,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) seeks a Senior Scientist, Biologics Analytical Development to drive analytical method development and protein characterization for biologic therapeutics.

The role involves supporting upstream/downstream process development, technology transfer to CROs/CMOs, and contribution to GMP regulatory documents. Strong leadership and cross-functional collaboration are essential.

Qualifications

• PhD in a scientific or engineering discipline is required.
• Minimum 5 years' experience in biotechnology/pharmaceuticals, preferably in process development.
• Experience in FDA-regulated environments is preferred.
• Excellent written and verbal communication and collaboration skills.

Responsibilities

• Develop analytical methods for biologic products and qualify them.
• Characterize recombinant proteins and conjugates using LC-MS, SEC, IEX, CE-SDS, and biophysical techniques.
• Support upstream and downstream process development and tech transfer to CROs/CMOs.
• Prepare regulatory documentation and contribute to GMP manufacturing support.
• Lead projects, mentor team members, and provide training as needed.

Skills

Biologics development

Analytical method development

HPLC

Mass spectrometry

Protein characterization

Process development

Regulatory documentation

CMC/regulatory submissions

Team leadership

Education

PhD in a scientific or engineering discipline

Job description

The Senior Scientist, Biologics Analytical Development, supports the development of recombinant protein production processes and analytical strategies for biologic therapeutics. This role is responsible for analytical method development, product characterization, and analytical support for process development activities involving microbial and mammalian expression systems. The position contributes to the advancement of innovative therapies addressing unmet medical needs.

Key Highlights:

• Analytical method development and optimization
• Protein and conjugate characterization using HPLC, CE, Mass Spectrometry, and biophysical characterization techniques
• Support of upstream and downstream process development
• CRO/CMO oversight and technology transfer activities
• GMP manufacturing support and regulatory documentation contributions
• Support extended characterization studies of recombinant proteins and protein conjugates using a variety of analytical techniques including LC-MS peptide mapping, U/HPLC, SEC, IEX, CE-SDS, iCIEF, GC/GC-MS, and biophysical techniques
• Process and review analytical data utilizing modern chromatographic and mass spectrometry CDS/MS software platforms
• Write and approve technical reports, SOPs, and method protocolsDevelop, optimize, and qualify analytical methods for biologic products.
• Characterize and quantify product and process related impuritiesSupport upstream and downstream process development programs.
• Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.
• Review analytical data and reports supporting GMP manufacturing activities.
• Author and/or review CMC sections of regulatory submissions.
• Independently design, execute, and analyze laboratory experiments.
• Evaluate complex scientific data and apply sound technical judgment.
• Collaborate with cross-functional teams and external partners.
• Author and approve technical reports, protocols, and scientific documentation.
• Maintain compliance with applicable regulatory and quality requirements.
• Support resource planning, equipment identification, and organizational initiatives.
• Lead projects, mentor team members, and provide training as needed.

Skills:

• Minimum 5 years of experience within the biotechnology or pharmaceutical industry, preferably in process development. Applicable postdoctoral experience may be considered toward the experience requirement.
• Demonstrated technical expertise, scientific creativity, and independent thinking.
• Strong problem-solving, organizational, and analytical abilities.
• Excellent written and verbal communication skills.
• Ability to effectively communicate scientific concepts to both technical and non-technical audiences.
• Strong interpersonal and collaboration skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to work effectively in a fast-paced, team-oriented environment.

Preferred Qualifications

• Experience working in an FDA-regulated environment.
• Knowledge of current GMP requirements and laboratory practices.
• Experience contributing to regulatory submissions.
• Prior leadership or management experience.

Education:

• PhD in a scientific or engineering discipline required.
• Equivalent experience may be considered.
• Exceptional candidates without a PhD may be considered based on demonstrated capabilities and significant relevant experience.