Senior Scientist, Biologics Analytical Development
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 Mass Spectrometry
- Support of upstream and downstream process development
- CRO/CMO oversight and technology transfer activities
- GMP manufacturing support and regulatory documentation contributions
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.
- Author and/or review CMC sections of regulatory submissions.
- Contribute to patent application activities as appropriate.
- 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.
Qualifications and 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.
- 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.
- Experience contributing to regulatory submissions.
- Prior leadership or management experience.
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.
ADDITIONAL INFORMATION
Nektar currently anticipates the base salary for the Associate Director, Clinical Pharmacology to range from $160,000 to $180,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion. The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical/Dental/Vision)
- Disability Insurance
- Holiday Pay
- Paid Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
For general information on company benefits, please go to https://www.nektar.com/careers.