Senior Scientist , Biologics Analytical Development

Summary

Leads analytical characterization and product quality support for process development and manufacturing of polymer and protein intermediates (microbial and mammalian), and polymer-protein conjugated drug substance and drug product. Performs CMC analytical characterization and and structural elucidation of process and product related impurities,. Plans project scope and provides technical oversight for product characterization studies, both internally and at CMO and/or CROs. Works closely with CMC team members to author and review relevant analytical sections for BLA and IND submissions.

Essential Duties and Responsibilities

• Has experience in PEG/polymer raw material characterization, vendor/CMO oversight, GMP batch release, extended characterization, process support, comparability studies
• Characterizes polymers and polymer protein conjugates by LC-MS, MALDI-TOF, U/HPLC and standard separations techniques (IEX-HPLC, icIEF, CE-SDS)
• Develop/Qualify/Validate in-process, release, and stability methods for PEGylated bulk drug substance, and drug product
• Plays a key role in the tech transfer of development methods into contract manufacturing organizations. Present and discuss the data and project progress at those meetings.
• Writes analytical method development and qualification reports.
• Writes and reviews appropriate technical SOPs for use internally and at CMO and/or CROs.
• Supports cGMP manufacturing at CMOs. Performs day-to-day planning, execution and analysis of laboratory experiments independently with minimal supervision.
• Interfaces with various departments and partners.
• Plans and coordinates activities with other team members.
• Writes and/or approves complex reports and protocols. Maintains knowledge of regulatory compliance requirements.
• May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements. Performs other duties as required.

Minimum Qualification Requirements

• · A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted.
• A minimum of 5 years work experience in a biotechnology/pharmaceutical industry, preferably in analytical development, is required. Post-doctoral work may serve as experience.
• Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.
• Expertise in analytical method development and characterization for biologics.
• Hands-on experience with most of the commonly used analytical equipment including Mass Spectrometry. Working knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment.
• Must have a solid understanding of biologics process development and standard analytical characterization techniques.
• Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
• Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.
• Excellent written and verbal communications and teamwork skills are essential.
• Must be able to clearly communicate scientific information both written and oral.
• Must be able to compose sound written work. Must possess good oral and written communication skills.
• Ability to present technical information to both technical and non-technical audiences is required.
• Must be able to demonstrate sound judgment.
• Excellent problem solving and troubleshooting skills.
• Ability to analyze and interpret data to make business critical decisions.
• Strong organizational skills are required.
• Ability to work on several projects or initiatives concurrently, with superior time management skills and ability to prioritize appropriately.
• Good computer skills are required.
• Working knowledge of MS word, Excel, Power point is required.
• Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are a plus.
• Experience with regulatory filings is a plus.
• Previous management skills are a plus. Must be willing to work as part of a team.
• Must be able to demonstrate good interpersonal skills.

ADDITIONAL INFORMATION

Nektar currently anticipates the base salary for the Senior Drug Product Process Engineer to range from $175,000 to $190,000 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.