Job Details
Posted 9 September, 2026
Job Id: 630758
Remote Senior Scientist, Biologics Analytical Development
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.
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.
- 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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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