- Manage R&D ADQC stability programs, such as but not limited to, providing sampling. volume forecast, coordinating with stability group on stability set-down and monitoring each stability pull-point.
- Manage in-house routine testing, such as stability and release testing, characterization, in-process samples analysis and reference standard qualification. Responsible for the overall quality and compliance of all the testing.
- Provide technical direction, mentorship and coaching to the analytical development team.
- Lead the design and interpretation of experiments to analyze raw materials.
- Keep accurate and detailed records of experiments in laboratory notebooks.
- Summarize data and communicate to cross functional team such as stability, PD and PM.
- Represent ADQC to attend X-Functional lab operation alignment meeting led by facility.
- Work within a team environment and provide support to further team objectives.
Requirements: - PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 8+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma/ Biotech industry required.
- Proven leadership skills.
- Outstanding organization and planning skills.
- Must be a strong scientific leader who can guide scientists with clear goals of developing analytical methods, and critically and skillfully review and assess analytical methods under development. May need to provide direction for troubleshooting various issues during method development.
- Proven track record of analytical development leadership for biologics and small molecules, experience with vaccines, carbohydrate, or conjugates is a plus.
- Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
- Knowledge of capillary electrophoresis and/or experience in use of such would be a plus.
- Experience in protein, carbohydrate, and conjugates analysis is highly desired, for example hands on experience and theoretical understanding of HPAEC-PAD, HPLC/UV/FLD, SEC-LC, SEC-MALS, and colorimetric assays are highly desired.
- Attention to detail and excellent skills in record keeping / documentation. Critical thinking and ability to analyze data.
- Strong interpersonal skills: ability to communicate effectively both verbally and in written formats.
- Ability to work with minimum supervision in a fast-paced, cross-functional environment and collaborate effectively with other team members. Eagerness and ability to learn and understand new concepts with ease.
Reports to: Associate Director, Analytical Development
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $144,000 – $162,000
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Group Leader, Analytical Development - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Looking for an energetic, talented and organized leader to join our Analytical Development team. Primary responsibility for the incumbent will be to lead a team of 4-5 to conduct RD stability studies, to perform assay control qualification and characterization testing. The leader is also responsible for overall Analytical Development lab operation including but not limited to instrument purchase, qualification, maintenance, and troubleshooting, as well as lab safety etc.
Essential Functions:
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