Sr. Scientist Biologics Analytical Development PHD

Role: Sr. Scientist Biologics Analytical Development (PHD)

Location: Remote

Summary

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, optimization, and validation Protein and conjugate characterization using HPLC, CE, icIEF, and UV Spectrometry
• Support of upstream and downstream process development
• CRO/CMO oversight and technology transfer activities
• GMP manufacturing support and regulatory documentation contributions
• Review analytical data supporting GLP and GMP manufacturing activities.

Essential Duties & Responsibilities:

• Develop, optimize, and qualify/validate analytical methods for biologic products.
• Characterize recombinant proteins and protein conjugates using a variety of analytical techniques.
• Support upstream and downstream process development programs.
• Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.
• Review analytical data supporting GLP and GMP manufacturing activities.
• Review CMC sections of regulatory submissions.
• Contribute to patent application activities as appropriate.
• Independently 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.

Qualifications and Skills:

• 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.
• Proficiency with Waters Empower software or other appropriate analysis software
• 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.

Minimum Professional Experience:

• 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.

Education Requirements:

• 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.

Thank You,

Satya

Satya@itengagements.com