Title: Associate Director/Director, Manufacturing
Location: Cambridge, MA
Reports to: Vice President, Manufacturing
The Role:
Vedanta is looking for a highly skilled biopharmaceutical Manufacturing Associate Director/Director for their Cambridge, MA manufacturing site. The position will be a key element to establish and operate Vedanta’s in-house CGMP manufacturing capabilities for Cell Banks, Drug Substance and Drug Product. This role will support the CGMP production of Vedanta’s Live Biotherapeutic Products (LBP), and will oversee a team of 3+ manufacturing supervisors and 12+ manufacturing operators. Applicants should be self-motivated, have strong communication skills, and be capable of working in a dynamic startup environment.
Here’s What You’ll Do:
- Manage the production schedule and the daily tasks of the manufacturing team to ensure the successful manufacture of Cell Banks, Drug Substance and Drug Product in a CGMP environment.
- Coordinate concurrent manufacturing operations in multiple manufacturing facilities.
- Assist with the facility startup and equipment qualification of a new late-phase clinical manufacturing suite.
- Author and revise SOPs and Batch Records.
- Support Tech Transfer activities for new processes and products.
- Own Manufacturing-related Deviations, CAPAs, and Change Controls.
- Coordinate across functional areas to obtain production materials.
- Manage and implement continuous improvement initiatives within the manufacturing department.
- Conduct department trainings.
- Represent manufacturing in cross-functional projects.
- Hire, train, and mentor a high-performing manufacturing team.
Requirements:
- BS in a scientific discipline or engineering.
- 7+ years of hands-on experience with CGMP manufacturing.
- 5+ years in a supervisory role.
- Direct experience with cell banking, cell culture, fermentation, cross-flow filtration, lyophilization, and/or capsule filling.
- Strong project management and organization skills.
- Strong communication and technical writing skills.
- Strong interpersonal and team building skills.
- Previous experience with technology transfer to a CGMP manufacturing environment.
- Previous experience with process validation.
- Ability to work in a fast-paced setting and adjust to a changing environment.
- Ability to work in a cleanroom environment where gowning and PPE are required.
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.
