Associate Manager, Preclinical Manufacturing
About Sail:
Sail Biomedicines is harnessing evolutionary and artificial intelligence to revolutionize programmable medicines. Sail’s platform combines first-in-class programmable RNA technology (Endless RNATM or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.
The Role:
Sail Biomedicines is seeking a self-starter for the role of Associate Manager, Preclinical Manufacturing to be a hands-on supervisor of internal production operations related to preclinical eRNA, and lipid nanoparticles (LNPs). As a leader within the Technical Operations department, you will play a key role in the preclinical supply of drug substances and drug products for Sail’s pipeline of internal and partnered programs. You will closely collaborate across TD&O, particularly with the pre-clinical manufacturing team and process development as well as with members of applications and platform teams.
Responsibilities
- Support activities related to production of preclinical supply of eRNA and LNPs for the evaluation of Sails product pipeline
- Support outsourcing of RNA supplies from external vendors
- Aid in the scheduling and execution of biomolecule production in alignment with corporate priorities and project timelines
- Review and monitor process and operational performance activities to ensure target quality profiles are achieved and metrics are met.
- Work closely with the process development, automation, pilot operations and supply chain teams to ensure highly efficient operations.
- Aid in the implementation of new processes / procedures within preclinical manufacturing facility
- Participate in documentation, investigations and resolutions of product/process issues and general continuous improvement activities
- Maintain scientific and technical expertise through familiarity with scientific literature and developing relationships with thought leaders.
- Perform batch record reviews for manufacturing records
Qualifications:
- MS and 6+ years, or BS 8+ years industry experience or equivalent in bioengineering, chemical engineering, or internal manufacturing operations
- Experience leading teams in production operations, including some aspects of resource scheduling, budgeting, supply chain activities, related to proteins or nucleic acids.
- Demonstrated ability in working with highly skilled teams in a fast-paced, entrepreneurial, and technical environment.
- Strong verbal, written communication, and problem-solving skills.
- Ability to work independently and manage multiple projects concurrently.
Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.
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