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Scientist / Sr. Manager, Downstream Development - CMC
South San Francisco, California, United States
Who we are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
Our Therapeutics team, which was established more than five years ago, has been actively identifying novel drug targets using 23andMe’s unparalleled database and developing a portfolio across several therapeutic areas, including oncology, cardiovascular and metabolic disease.
We are seeking a highly motivated Scientist / Senior Manager to join our expanding Therapeutics team. You will lead the CMC downstream process design, development and validation and work together with multiple cross-functional project teams to support product manufacturing and regulatory filing.
More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
What you’ll do
- Oversee and coordinate the CMC downstream process development including chromatography capture steps, viral clearance strategies, polishing operations, and filtrations/concentration/formulation steps at CDMOs and run in-house purification optimization experiments to ensure the timeline and quality
- Communicate and collaborate with cross-functional colleagues for successful execution/completion of project
- Design robust and scalable process operations for scale-up cGMP manufacturing and support technology transfer from pilot run to GMP
- Provide person-in-plant (PIP) support for critical manufacturing operations as needed
- Review and approve downstream CMC related protocols, SOPs, reports, and cGMP-compliant documentation
What you’ll bring
- Bachelor’s or Master’s in Biochemistry, Biochemical Engineering or related fields
- Minimum of 7 years’ relevant industry experience in large scale protein or antibody purification
- Advanced hands-on experience in biologics-related purification techniques such as column packing, different modes of chromatography, UF/DF and viral clearance
- In-depth knowledge of regulatory guidelines in cGMP activities
- Experience in authoring IND/IMPD/BLA CMC sessions is highly desirable
- Broad knowledge in cell line, upstream, formulation and analytical development is a plus
- Excellent teamwork skills and ability to build effective relationships with cross-functional teams
- Exceptional interpersonal, communication and influencing skills
Note: Job title will be commensurate with experience and academic credentials
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. The company was named by Glassdoor as one of the Best Places to Work in 2019, MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017." 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. More information is available at www.23andMe.com.
At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at email@example.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.