Senior Scientist - Biologics Analytical Development (CMC)

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

Essential Duties & Responsibilities

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.