Associate Director, Analytical Chemistry (A.S.) @ Metagenomi - Emeryville, CA
2 months ago
Associate Director, Analytical Chemistry (A.S.)
Metagenomi - Emeryville, CA
At Metagenomi, we are accelerating innovation in cell and gene therapy with a wave of proprietary CRISPR-based systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful therapeutic tools that can be leveraged by partners and fuel our own pipeline of potentially curative medicines. Our goal is to revolutionize gene editing and unlock its power for the benefit of patients around the world.
About the Role
We are seeking an experienced and motivated Associate Director, Analytical Sciences (AnalyticalChemistry) to support Metagenomi’s new and growing Analytical Sciences team within the TechnicalOperation group. Reporting to Senior Director of Analytical Sciences, this position is a senior member of the Analytical Sciences team and will play a crucial role, including managing the analytical chemistry team in day-to-day operations (method development, transfer, qualification and validation) and material and lot release testing. The ideal candidate would have experience in building a new team, developing and validating a small molecule, lipid and RNA/oligonucleotide assay, performing a Design ofExperiments (DoE) study and collaborating with contract testing laboratories for method transfers and material testing. This role works in both QC and analytical development labs and supports both the GMPManufacturing and Process Sciences/Development teams. This position is a combination of office based(40%) and laboratory based (60%), and includes data analysis and experimental design, supporting all drug modalities (both in vivo and ex vivo therapies) at Metagenomi.
The exact level of this position will be based on experience and qualifications, and as such, we encourage all interested candidates to apply. If you have relevant experience or knowledge that is not reflected on your resume, we welcome you to include a comment explaining any additional details you would like us to consider when reviewing your application.
By the end of your first year, you will have a chance to demonstrate your ability to:
- Act as the subject matter expert on small molecule, lipid and RNA/oligonucleotide assay development and validation to support potency, impurity, identity and other characterization testing
- Build and oversee the analytical chemistry team to support all modalities at Metagenomi, manage team goals and expectations, and maintain efficient utilization of resources
- Manage small molecule, lipid and RNA/oligonucleotide test method development, transfer, qualification and validation for in-process materials, lot release and stability, as needed, to support the Process Development and Manufacturing teams, oversee the execution of routine testing (inhouse and outsourced)
- Establish inhouse infrastructure for the analytical chemistry team e.g., analytical instrument procurement/qualifications, determination and control of critical reagents etc.
- Design and execute DOE studies using statistical tools e.g., JMP to generate optimal and robust analytical tests
- Author and/or review SOPs or work instructions, study design and protocols, technical protocols and reports, method transfer plan and reports
- Maintain accurate and complete documentation of any scientific experimental plan, data and report
- Support QC and manufacturing personnel in the identification of root cause analysis and provide technical advice on small molecule-, lipid- and RNA/oligonucleotide-related topics
- Ensure that all work follows the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)
- Provide analytical control assessments and continuous improvement opportunities
- Lead laboratory investigations, deviations, OOS/OOT, CAPAs, Change Controls and risk assessments related to small molecule, lipid and RNA/oligonucleotide tests
- Present analytical data reports clearly and concisely to senior management, including small molecule, lipid and RNA/oligonucleotide test performance metrics and trends.
- Assist in the preparation of CMC dossiers and data packages for interactions between Metagenomi and regulatory agencies
- Keep current on Environment, Health & Safety policies, ensure safe environmental and working conditions in the lab
- Requires MSc/PhD degree in Organic chemistry, analytical chemistry, or other closely related life sciences discipline, with at least 8+ (for PhD) or 17+ years (for MSc) of relevant experience along with previous supervisory roles in an analytical development lab and/or a GMP QC analytical laboratory
- In depth understanding and hands-on experience in small molecule, lipid and RNA/oligonucleotide assay, and in one or more of the following areas: separation methods (CE, SEC, RP, FFF, affinity chromatography), residual solvent and small molecule impurities, mass spectrometry (qToF for lipid and RNA/oligonucloeitde, intact mass analysis, lipid and RNA modification), light scattering methods (SEC-MALS, DLS), thermal stability (DSF, DSC), RI, ELSD, CAD, NMR, slope spectroscopy etc.
- Experience with small molecule, lipid and RNA/oligonucleotide test method development and validation is required
- Experience with gene and cell therapy, mRNA/LNP, CRISPR/Cas technology is desirable
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) for pharmaceutical and biopharmaceutical drugs, including specific review or preparation of INDs, BLAs, IMPDs, or supplements
- In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations
- Familiar with QbD principles and DOE approaches for method development and optimization
- Experience with electronic systems such as ELN, LIMS, Trackwise, Veeva, etc., is an advantage
- Flexible to meet changing demands to support process development and manufacturing activities
- Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity
- Ability to prioritize project work and make effective use of available resource to meet agreed timelines
- Ability to communicate at all levels and across various functions
- Handle issues appropriately and with a sense of urgency
- Ability to problem solve and identify root cause
- Completes tasks where judgment is required in resolving problems and recommendations
- Frequent use & general knowledge of industry practices, techniques and standards
- Strong interpersonal and communications skills; written and oral
- Able to quickly learn and adapt to new software tools (ex: Google Suite, Slack, etc.)
- Highly collaborative, team-oriented, and considerate of the needs of others
- Thrives in a fast-moving, results-oriented startup environment with urgent deadlines
- Independent and self-sufficient, but knows when to ask questions or seek support
- Self-motivated, passionate about your work, and eager to continuously learn more
About the Company
- We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating disease
- We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun
- Metagenomi offers competitive salary, annual target bonus, equity in an early-stage startup, and a comprehensive benefits plan, including 401(k) matching, a retirement safe harbor plan, and other perks
At Metagenomi, we know that our people drive our success. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We are an equal opportunity employer and believe in and value diversity and inclusion. All employment is decided on the basis of qualifications, merit, and business need.
If you need assistance or accommodation due to a disability, you may contact us at [email protected] and we would be happy to help.