About Senda Biosciences
Senda Biosciences, Inc. is uniquely positioned to transform human health by harnessing millions of years of evolution to program targeted, potent and tunable medicines. Nature has provided the codes to program human cells – both from within (mRNA) and from outside – from what surrounds them. The trillions of non-human cells in the human ecosystem have evolved natural nanoparticles that precisely shuttle biomolecules into human cells, providing the missing pieces to fully unlock programmable medicines. Senda’s proprietary platform includes the first-ever atlas of nature-derived programmable systems at the molecular level and across all kingdoms of life – accessing the entire code provided by nature required to program cells. With this platform, Senda is developing a new class of SendRNA™ medicines. The unique properties of these medicines create new frontiers for mRNA therapeutics and vaccines for infectious, genetic, autoimmune, and metabolic diseases and oncology indications – with further potential to transform the gene editing and protein-based therapy landscapes as well. Based in Cambridge, MA, Senda was founded by Flagship Pioneering. For more information, visit sendabiosciences.com or follow us on Twitter and LinkedIn.
The Process Development and Manufacturing Sciences (PDMS) department at Senda Biosciences is responsible for development, manufacturing and establishing CMC of Senda’s Drug substance and Drug products. We are seeking to hire a highly motivated and strategic thinker to join the PDMS department at Senda Biosciences as Director of Technical Operations.
The successful candidate will be responsible for process transfer and manufacturing of Senda’s drug substance and drug products and managing Senda’s network of external suppliers.
- Direct / oversee contract manufacturing, packaging and labeling operations for the company’s drug substances and drug products.
- Responsible for preparation of RFP’s, SOW, evaluation and selection of CDMO’s, establishing production plans and maintaining clinical materials inventory
- Working closely with Senda’s process development team, ensure successful tech transfer, process scale-up, optimization, qualification and validation of activities related to all manufacturing operations.
- Review and approve Master Service Agreements, Quality Agreements, Batch records, manage Non conformances and Investigations.
- Partner with Senda’s clinical operations team to ensure an adequate supply of clinical materials and on time delivery to clinical sites.
- Establish the manufacturing organization and build a high functioning team.
- Develop Senda’s internal manufacturing strategy and execution plan.
- Review CMC sections of IND filings and associated regulatory documentation
- Active participation in external conferences
- Occasional nonstandard work hours and travel to CDMO sites required
- Ph.D in Pharmaceutics, Life Sciences, Chemical Engineering or related discipline with 10 years’ experience or BS / MS with 12 years’ experience in technical operations and GMP Manufacturing.
- Prior experience working with scale-up of complex manufacturing processes and managing CDMO’s
- Working knowledge of Quality systems, GMP-related requirements and regulatory requirements for CMC and ICH guidelines is required
- Prior experience in preparation of IND’s or IMPD’s, addressing regulatory questions
- Demonstrated creativity and problem-solving skills
- Ability to work independently, as well as part of a team
- Organized, detail-oriented, and demonstrated independent thinker who continuously seeks innovative solutions
- Effective verbal and written communication skills
Senda Biosciences is an Equal Opportunity Employer. Senda 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.