Sr. Scientist, Biologics Product Development
- Employer
- Nektar Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Jan 21, 2021
View more
- Discipline
- Marketing, Product Development/Management, Science/R&D, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Nektar has an exciting opportunity for a Sr. Scientist, 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 Sr. Scientist'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 5 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.
Additional Requirements:
- 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.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Company
Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.
Stock Symbol: NKTR
Stock Exchange: NASDAQ
- Website
- http://www.nektar.com/
- Phone
- 415-482-5300
- Location
-
455 Mission Bay Blvd South
San Francisco
California
94158
United States
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