Scientist II, Biologics Product Development
Posted on Apr 6, 2021 by Nektar Therapeutics
Nektar has an exciting opportunity for a Scientist II, Biologics Product Development to join our talented Product Development CMO team.
This position directly contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
The Scientist II's primarily responsibilities will be:
Participate in and lead formulations and process development activities for protein therapeutics.
Design and conduct pre-formulation and formulation development studies for parenteral liquid and lyophilized biologics and manufacturing feasibility for pre-clinical and clinical trials.
Prepare CMC drug product sections for Regulatory filings and provide technical oversight of clinical scale to commercial scale production.
Implements formulation development based on sound physicochemical information derived from pre-formulation studies. Designs, executes, and interprets formulation studies, planning activities to meet project timelines by working closely with project managers and senior technical team members of the biologics function.
Acts as the lead and in-house formulation development expert on programs. Plans project scopes of work internally and at contract development organizations. Plays a key role in the tech transfer of formulations into contract manufacturing organizations.
Presents and discuss the data and project progress, utilizes Design of Experiments (DoE) and statistical data evaluation techniques. Writes formulation development plans and formulation development reports. Writes and reviews appropriate technical MBR, SOPs for use internally and at CMO and/or CROs. Support cGMP manufacturing at CMOs.
Performs day-to-day planning, execution and analysis of laboratory experiments independently with minimal supervisions. Defines complex problems, develops approaches and develops experiments with sound judgment.
A PhD in a scientific or engineering discipline, or equivalent education and experience, is required. A minimum of 4 years work experience in a biotechnology/pharmaceutical industry is required, experience in biologics formulation and drug product process development is highly desired. Ability to present technical information to both technical and non-technical audiences. Post-doctoral work may serve as experience.
Working knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment. Experience with regulatory filings is a plus.
Hands-on experience with commonly used analytical and formulation production equipment is needed. Experience in design of experiments (DoE) and associated software.
Good interpersonal skills.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.