Senior Manager or Associate Director, Analytical Science & Technology
South San Francisco, CA, USA
Posted on Wednesday, May 3, 2023
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.
This posting is for a position within the Analytical Science and Technology (AST) group. The level of the position will be dependent on candidate’s education and experience. This role is based in Alameda, CA and regular on-site presence is required and some travel to the company’s SSF (or other external sites) as needed.
The Sr. Manager/AD role provides global support for the company’s cell/gene therapy GMP operations, including: analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation. As cell therapy is still an emerging/fast progressing field, passion for continuous learning and capability to work in a highly dynamic, fast pace, collaborative environment is key to the success of this role.
- Design and perform lab experiments with minimal guidance.
- Serve as subject matter expert and represent AST in cross-functional teams (CMC, Regulatory, Quality, Manufacturing, MSAT, and Tech Ops, etc.)
- Oversee method transfer, qualification/validation, trending across analytical network (internal and external).
- Collaborate with MSAT/Manufacturing on process control and testing strategy requirements, and advise on analytical plan for extended process optimization and characterization studies.
- Lead technology transfer of analytical assays into the Alameda GMP facility
- Work closely with Analytical Development groups (internal and external) to transfer/co-qualify new methods.
- Collaborate with contract testing labs to ensure successful completion of projects to the standards of Senti.
- Author experimental protocols/reports and regulatory submissions related to analytical optimization, qualification/validation, and trending.
- Lead assay troubleshooting and projects to improve method performance across network.
- Support or lead OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions.
- Contribute to specification, comparability setting strategy.
- Response to agency questions related to analytical methods/specification.
- Provide technical support and guidance for the use and maintenance of scientific equipment and instrumentation, computer systems.
- Working in and leading cross-functional matrixed teams
- Experience partnering with project management to set schedules, goals, and deliverables
- Ability to synthesize information across scientific, operational, and business needs to make and recommend decisions to meet company objectives
- BS with 6+, MS 4+, Ph.D. 2+ years biopharmaceutical experience recommended
- Knowledge of general protein/nucleic acid/cell biology chemistry/biochemistry
- Knowledge of molecular biology concepts and technologies
- Understanding of GMP requirement and regulations (FDA/EMA/ICH etc.)
- Experience with Cell based bioassay (potency, infectious titer assay etc.), Flow cytometry, PCR (qPCR, dPCR, etc), Protein analysis (ELISA, multiplex methods, MS, etc), Genomic Sequencing (Sanger, NGS), Spectroscopy (UV, fluorescence, FTIR), Chromatography (RP, SEC, IEX, HILIC etc.), Particle analysis
- Strong critical thinking and problem-solving skills
- Experience with method development, transfer, qualification and validation.
- Experience working in QC and/or a GMP environment.
- Experience in gene/cell therapy field.
- An excellent and persuasive communicator.
- Energetic, flexible, collaborative and proactive.
- Strong communication, scientific writing and presentation skills
Salary and Benefits:
- Compensation for this role includes base salary, annual target bonus and equity
- The base salary range for this role is $XXX-XXX. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
- Significant growth opportunity as the company expands
- Empathetic, supportive and collaborative colleagues and work environments
Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.
We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.
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