- Lead drug substance team through preclinical and clinical development to commercialization. The role will have end to end responsibility of drug substance process development and technical support.
- There is potential for the role to assume leadership within CMC.
- Drive, build, and enhance strategic relationships with CDMO and other partners to advance drug development pipeline.
- Provide strategic and operational oversight, content creation of all regulatory documents and request for information.
- Partner broadly throughout the organization including program teams, research, clinical development, medical affairs, new product planning, regulatory affairs, and corporate communications.
- Represent drug substance holistically internally and externally as needed. Activities include due diligence, regulatory interactions, indication expansion, technology and innovation opportunities, project team and portfolio review committee.
- Develop, own, and execute against the operational budget pertaining to drug substance including manufacturing and process development.
- Provide mentorship and guidance to colleagues within the organization.
- PhD in Organic Chemistry with 15+ years of industry experience in process chemistry leadership roles with a demonstrated track record of success.
- Strong understanding of the legal, regulatory, and compliance environment, including a strong understanding of guidelines and best practices for drug substance development.
- Experience in regulatory filings.
- Highly collaborative with an ability to successfully develop and maintain strong working relationships cross-functionally with key internal stakeholders and external CMDO vendors and partners.
- Self-driven and demonstrated ability in working with a diverse team in a fast-entrepreneurial setting.
- An extensive track record of presentations, publications, and patents.
- Excellent communication and presentation skills.
- Extensive experience leading CMC teams and representing CMC in broader project teams.
- Strengths in the following areas: creativity, problem-solving, and managing relationships within a matrix project team environment.
- A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases.
- Push Boundaries: We create a legacy with breakthrough science in service of patients.
- Inject Energy: We build strengths from different perspectives and tell it like it is
- Own it: We transcend our job descriptions and relentlessly follow through on our commitments.
- Go all out: We work quickly and with conviction.
-
Senior Manager, Regulatory CMC Lead
2 weeks ago
Biogen Cambridge, United StatesJob Description · About This Role · Please make sure you read the following details carefully before making any applications. · This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and plan ...
-
Senior Manager, Regulatory CMC Lead
2 weeks ago
Biogen Cambridge, United StatesJob Description · About This Role · This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation ...
-
Senior Manager, Regulatory CMC Lead
1 week ago
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Respon ...
-
Vice President, Td and Cmc Strategy Lead
1 week ago
Moderna Norwood, United States**The Role**: · This pivotal role is divided into two primary functions within the organization: · **Technical Development Initiatives Leader**: Directs the governance of Technical Development (TD) initiatives, focusing on strategy development and coordination across project team ...
-
Sr. Director, CMC Finance, Drug Substance
3 weeks ago
Moderna, Inc. Norwood, United States Full timeThe Role: · This role is an exciting opportunity to be a critical part of the talent engine fueling a high growth organization that has rapidly developed and commercialized Spikevax and, has the potential to launch up to twenty-two products by 2028.Moderna is looking for a Sr. D ...
-
Head, Clinical Pharmacology
2 weeks ago
Leap Therapeutics Cambridge, United States**Head, Clinical Pharmacology**: · **Company Summary**: · **General Responsibilities**: · ***The Head of Clinical Pharmacology will be responsible for developing and executing the clinical and non-clinical pharmacology strategies for compounds from the pre-clinical stage through ...
-
Recovery Specialist
1 week ago
Bay Cove Human Services Somerville, United States Part timeBay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, menta ...
-
Recovery Specialist
2 weeks ago
Bay Cove Human Services Somerville, United States Part timeBay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, menta ...
-
Biogen Cambridge, United States**Job Description** About This Role** · Biogen is seeking a motivated and creative process chemist to join our small molecule development team in Cambridge, MA. This individual will provide support for chemical process research and development of Biogen's small molecule programs ...
-
Safety Officer
2 weeks ago
Bay Cove Human Services Boston, United StatesBay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, menta ...
-
Director, Regulatory Affairs Vaccines Cmc
2 weeks ago
ARIAD Boston, United States**Pay Range**: · $169, $266,200.00 · **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169, $266,200.00**About the role**: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transfor ...
-
Sr. Scientist, Process Research
1 week ago
Takeda Pharmaceutical Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Associate Fellow, Process Research
1 week ago
Takeda Pharmaceutical Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Drug Substance Business Standards Lead
1 week ago
Moderna, Inc. Norwood, United StatesThe Role: · The Drug Substance Business Standards Lead is responsible for driving standardization of business processes and systems across the Global Drug Substance Network, with an emphasis on simple, robust solutions that fit the organization's broad mission. This role involves ...
-
Manager, Employee and Labor Relations
1 week ago
Mass General Brigham Somerville, United States**Manager, Employee and Labor Relations** · **This is a hybrid role that requires at least 1x/week onsite at Assembly Row. Travel to other Mass General Brigham sites is required when necessary for completing employee investigations.** · As a not-for-profit organization, Mass Gene ...
-
Vice President, TD and CMC Strategy Lead
5 days ago
Moderna, Inc. Norwood, United States Full timeThe Role: · This pivotal role is divided into two primary functions within the organization: · Technical Development Initiatives Leader: Directs the governance of Technical Development (TD) initiatives, focusing on strategy development and coordination across project teams. This ...
-
Drug Substance Business Standards Lead
3 weeks ago
Moderna Norwood, United StatesDrug Substance Business Standards Lead page is loaded · Drug Substance Business Standards Lead · Apply · locations · Norwood, Massachusetts · Drug Manufacturing · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · R15407 · The Role: · The Dru ...
-
Drug Substance Business Standards Lead
1 week ago
BioSpace Norwood, United StatesJob Details · The Role: · The Drug Substance Business Standards Lead is responsible for driving standardization of business processes and systems across the Global Drug Substance Network, with an emphasis on simple, robust solutions that fit the organizations broad mission. This ...
-
Drug Substance Business Standards Lead
1 week ago
Moderna Theraputics Norwood, United StatesThe Role: · The Drug Substance Business Standards Lead is responsible for driving standardization of business processes and systems across the Global Drug Substance Network, with an emphasis on simple, robust solutions that fit the organization's broad mission. This role involves ...
-
medical assistant/med secretary
3 weeks ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · RegularScheduled Hours: · 40Work Shift: ...
Head of Drug Substance/CMC Lead - Somerville, United States - Cellarity
Description
What if you could join a rapidly growing company and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way?
What this position is all about: Cellarity is seeking a highly motivated and innovative Director/Senior Director with expertise in the field of small molecule process chemistry to play a vital role in the company's efforts to advance the company pipeline into clinical development. This role will oversee all drug substance process development for the company and will play a key role in driving the portfolio forward from late discovery and early process development through late stage, including process characterization, validation, and commercialization. The Head of Drug Substance will have a pivotal role in providing strategy, shaping future organizational design, and innovation for the organization. This senior leadership position requires a strategic thinker with a deep understanding of transitioning molecules from late discovery into clinical development, extensive experience in early phase clinical development and preferably late stage and commercialization experience. We are seeking someone with exceptional relationship building, technical skills, and the ability to collaborate cross-functionally to ensure efficient and effective development. This role will report into to the Head of Integrated Drug Creation.
What you would be responsible for:
What experiences will you need:
What sets you apart:
What it's like to work at Cellarity
At Cellarity, we
