Title: Head of Production

Location: Cambridge, MA

Reports to: Chief Operating Officer

The Role:

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.

Requirements:

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.

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.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Are you legally authorized to work in the United States? *

Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)? *

If you'll require the company to commence ("sponsor") an immigration or work permit case in order to employ you, either now or at some point in the future, then you should select Yes. Otherwise, select No.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Vedanta Biosciences’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

Autism
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
Blind or low vision
Cancer
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or hard of hearing
Depression or anxiety
Diabetes
Epilepsy
Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
Intellectual disability
Missing limbs or partially missing limbs
Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Please reach out to our support team via our help center.