Senior Scientist – Biologics Analytical Development

- 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 pepProduct 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 protocols.
- Develop, optimize, and qualify analytical methods for biologic products.
- Characterize and quantify product and process related impurities.
- Support 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 Client 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.