Senior Scientist Analytical Development

Job Description

Job 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.

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 CClient 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.

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 activit.

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.

Required 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.