Address
Form of workTitle: Manufacturing Investigator
Location: Cambridge, MA
Reports to: Director, CMC Operations
The Role:
The Manufacturing Investigator will play a key role in supporting in-house CGMP manufacturing operations and ensuring the timely release of Vedanta Bioscience's Live Biotherapeutic Products. The successful candidate should be self-motivated, have strong technical writing and project management skills, and be capable of working in a highly dynamic start-up environment.
Here's What You'll Do:
Requirements:
Why join Vedanta Biosciences:
Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology.
We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.
Our Vision:
We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia
Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.
Location: Cambridge, MA
Reports to: Director, CMC Operations
The Role:
The Manufacturing Investigator will play a key role in supporting in-house CGMP manufacturing operations and ensuring the timely release of Vedanta Bioscience's Live Biotherapeutic Products. The successful candidate should be self-motivated, have strong technical writing and project management skills, and be capable of working in a highly dynamic start-up environment.
Here's What You'll Do:
- Lead CGMP investigations, including root cause analysis, impact assessments, and CAPA planning
- Manage the closure of CGMP deviations, investigations, CAPAs, and change controls related to manufacturing operations
- Lead cross-functional investigation teams for complex/critical events
- Establish robust technical writing and investigation guidelines and training materials
- Facilitate review forums for deviations, investigations, and CAPAs
- Manage and communicate deviation and investigation metrics to identify trends and continuous improvement opportunities
- Collaborate with key stakeholders to improve existing quality systems workflows
- Support system maturity projects for global late-phase clinical manufacturing
Requirements:
- Bachelor's degree in a scientific discipline, engineering, or a related field
- 5+ years of experience in Quality Assurance, Manufacturing, or a technical support role
- Strong communication and technical writing skills
- Prior experience authoring deviations, CAPA, and change controls preferred
- Solid understanding of relevant FDA/EMA/ICH quality requirements
- Experience with Veeva Vault QMS or similar software
- Strong analytical, organizational, and critical thinking skills
- Robust communication and technical writing skills
- Ability to work in a fast-paced setting and adjust to a changing environment
Why join Vedanta Biosciences:
Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology.
We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.
Our Vision:
We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia
Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.
