Title: Head of Production
Location: Cambridge, MA
Reports to: Chief Operating Officer
The Head of Production will oversee the manufacturing of bacterial products for Vedanta Biosciences. This individual will direct, manage, and develop a multidisciplinary team within the Manufacturing, Supply Chain, Technical Operations, and Facilities departments. The successful candidate will embrace the leadership component of the role and will actively mentor their team and foster a culture of continuous improvement.
The Head of Production will operate both strategically and operationally and must be comfortable tailoring their message and communication style depending on the audience, context, and subject matter. This individual will interact with colleagues across the organization, and they must be adept at building strong working relationships across level and function. The ability to communicate clearly, genuinely, and credibly with all levels is a must.
This position requires broad expertise in all aspects of manufacturing, a thorough understanding of cGMP, and a strong working knowledge of CMC regulations in the US and EU. It is expected that the ideal candidate will lead a large GMP production team while accomplishing the timely completion of assignments and reporting of unexpected issues. This individual will lead the process validation for the company’s late-stage lead candidate. This role will closely work with the regulatory function to support the submissions of all CMC-related documentation required throughout the product lifecycle.
Here’s What You’ll Do:
- Establish, implement, and communicate a strategic direction for the organization’s technical and manufacturing functional areas.
- Develop and execute an operational strategy which encompasses the sourcing of critical raw materials through finished drug product to support the supply of drug product for clinical trials and commercial use.
- Lead manufacturing capacity planning and capital project execution to support commercial launch.
- Select, manage, and mentor a large, multi-tiered team of professionals. In particular, develop and coach people managers to ensure strong people management principles are cascaded fully into the production team
- Drive effective decision-making while proactively identifying potential risks to GMP timelines and deliverables; communicate/implement effective risk mitigation strategies.
- Develop yearly department budgets and execute activities per budget.
- Provide effective leadership and training to team members.
- Ensure that the site is properly staffed, and personnel are appropriately trained to comply with CGMP manufacturing requirements.
- Ensure a timely delivery of Drug Product required to supply new and ongoing clinical trials.
- Support internal process transfer activities from Process Development/Technical Operations to GMP.
- Drive the timely review of all CMC-relevant documents, such as technical reports, batch records, protocols, and change controls to ensure compliance with all applicable regulations and industry standards.
- Collaborate with Quality Assurance and Quality Control to work toward efforts that meet or exceed cGMP regulations and guidance.
- Identify, recommend, and implement new processes, technologies, and systems to improve and streamline organizational processes and use of resources and materials.
- Present periodic performance reports and metrics (KPIs) to the leadership team.
- Maintain knowledge of emerging technologies and trends in operations management.
- Participate in the writing and reviewing of CMC regulatory documents throughout the product development lifecycle of Vedanta’s portfolio.
- Bachelor’s Degree in Biological Sciences/Engineering, or related field with at least 15 years of relevant industry experience.
- The ideal candidate will have strong bacterial/large molecule CMC experience across multiple functional areas.
- Understanding of CMC regulatory requirements for advancing biological products from clinical development to licensure is required.
- Strong technical skills to understand and support manufacturing processes and process validation, including knowledge of upstream, downstream, and powder handling principles and practices for oral dosing form products.
- Extensive knowledge of the principles, procedures, and best practices in the industry. Specifically for late-stage validation to commercialization of products.
- Excellent verbal and written communication skills.
- Strong supervisory and leadership skills.
- Ability to work collaboratively and across different functions in a fast-paced environment.
- Excellent organizational skills and attention to detail.
- Strong analytical and problem-solving skills.
- Requires onsite presence in Cambridge and Acton, MA
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.
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.