Associate Director, Analytical Development
- Employer
- Nektar Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Jan 15, 2021
View more
- Discipline
- Information Technology, Business/Data Analytics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Nektar is seeking a talented, experienced, and highly motivated scientific expert to join our Analytical Development department in support of the company's growing pipeline of therapeutic biologics drugs.
Nektar is seeking a talented, experienced, and highly motivated scientific expert to join our Analytical Development department in support of the company's growing pipeline of therapeutic biologics drugs. The successful candidate will have important leadership roles in the company's growth, with respect to the development of both products and the organization, through expertise in product characterization, analytical method development/validation and IND/BLA document preparation. The position, which will be located at the company's San Francisco, CA headquarters, will also have a significant amount of direct interactions with staff at our Huntsville, AL site, and also with our contract laboratories and contract manufacturing facilities. The individual in this position will serve as a collaborator and a scientific and technical leader on a variety of teams within the company and will represent the company in the same roles during interactions with regulatory agencies, corporate partners and collaborators.
Essential Duties and Responsibilities
Scientific oversight of analytical development for recombinant DNA-derived biologics products (process intermediates, protein intermediate, PEGylated drug substance and drug product), including activities performed internally and at contract facilities:
- Product characterization
- Analytical method development, optimization, transfer, and qualification/validation
- Quality control testing, especially cGMP
Minimum Qualification Requirements
A minimum of a Bachelor's degree in a life sciences, chemistry, or engineering discipline is required; an advanced degree is strongly preferred. A minimum of 10 years of experience in the biotechnology and/or pharmaceutical industry is required. A minimum of 8 years of experience in the analytical development of therapeutic proteins or other biologics, with a proven track record of managing and advancing both groups and projects, is required. Expertise in biopharmaceutical cGMP is essential. In-depth familiarity with state-of-the-art analytical techniques to elucidate protein structure and function is required. Experience in developing recombinant DNA-derived therapeutics from both microbial and mammalian sources is highly desired, as is experience in the development of biologics modified with PEG or other molecular entities. A track record in collaboration with representatives across multiple technical functions, including (but not limited to) Process Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs, is required. Prior experience with technology transfer and providing oversight to contract manufacturing organizations and contract testing laboratories is essential. Prior experience with authorship in regulatory filings and regulatory agency interactions is required; experience with BLA/NDA/MAA filings is advantageous. Experience in setting business-appropriate expectations for staff and project teams is required. A proven ability to develop and manage to a budget is a must. Excellent verbal and written communication and teamwork skills are required. Strong project management skills are essential, especially the ability to negotiate proper milestones and track progress against them. Demonstrated ability to develop successful relationships with and influence stakeholders, both internal and external, is essential. The ability to change the thinking or to gain acceptance of others in sensitive situations, using strong negotiation and influencing skills, is essential.
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.
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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