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Sr. Scientist II, Monoclonal Antibodies
455 Mission Bay Boulevard South San Francisco, CA 94158 US
Job Description
- FDA
- ANTIBODY
- PROBLEM SOLVING
- ANTIBODIES
- MONOCLONAL
- PRODUCT DEVELOPMENT
- PROCESS DEVELOPMENT
- DOCUMENTATION
- GMP
- PROJECT PLANS
This position will work on the process development of monoclonal antibodies to be used for clinical study involving complex problems in which analysis of situations or data requires an in-depth evaluation of various factors and contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
- Leads projects related to the execution of process and/or product development activities of monoclonal antibodies and participates in planning and strategy.
- Applies scientific principles and concepts to potential products and problems.
- Interfaces with various internal and external teams.
- Maintains broad knowledge of state-of-the-art principles and theories.
- Design, develop, and support activities related to upstream/downstream process development and manufacture of monoclonal antibodies.
- Lead multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks.
- Review and approve technical protocols, reports, and GMP batch documentation.
- Author and review regulatory sections in support of IND submissions.
- Defines complex problems, develops approaches and develops experimental plans with sound judgment.
- Exercises judgment within broadly defined practices and policies in selecting, and may recommend new methods, techniques and evaluation criteria for obtaining results throughout antibody production processes.
- May independently represent the Company to outside organizations.
- A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted.
- A minimum of 8 years work experience in a research and/or development environment focused on monoclonal antibody production is required.
- Post-doctoral work may serve as experience.
- Exceptional non-PhDs with demonstrated capabilities and/or significant experience across mAb upstream, downstream, and formulation development may also be considered.
- 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.
- 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.
- Must be able to demonstrate problem solving capabilities.
- Experience working in an FDA regulated environment and knowledge of current GMPs is highly desired.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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