Head of Drug Substance/CMC Lead

3 weeks ago

Somerville MA, United States Cellarity Full time

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:

  • 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.

What experiences will you need:

  • 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.

What sets you apart:

  • 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.

What it’s like to work at Cellarity

At Cellarity, we

  • 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.

#J-18808-Ljbffr

  • Head of Drug Substance/CMC Lead

    1 month ago

    Somerville, United States Cellarity Full time

    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...

  • Head of Drug Substance/CMC Lead

    1 month ago

    Somerville, United States Cellarity Full time

    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...

  • Head of Drug Substance/CMC Lead

    2 weeks ago

    Somerville, United States Cellarity Full time

    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...

  • Head of Drug Substance/CMC Lead

    1 month ago

    Somerville, United States Cellarity Full time

    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...

  • Head of Drug Substance/CMC Lead

    1 week ago

    Somerville, United States Cellarity Full time

    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 ...

  • Director, CMC Bioconjugation

    2 months ago

    Waltham, MA, United States Dyne Tx Full time

    Director, CMC Bioconjugation & External Manufacturing With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular...

  • Regulatory CMC Director

    3 weeks ago

    Boston, MA, United States Dennis Partners Full time

    Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC,...

  • Head of Process Development CMC

    3 weeks ago

    Boston, MA, United States EPM Scientific - Phaidon International Full time

    Head of Process Development Greater Boston Area | East Coast Competitive Compensation + excellent bonus/benefits Duties and Responsibilities: To be successful in this role, deep understanding of Process Development is required. You should be able to drive continuous improvement initiatives across biopharmaceutical process development stages. Provide...

  • Chief Technical Officer

    3 weeks ago

    Boston, MA, United States Kennedy Bond Full time

    We are partnering with a cutting edge Biotech still operating in stealth mode, on a Chief Technical Officer search. As the CTO/ Head of CMC, you will be responsible for establishing the formulation platform for our lead discovery Program and provide strategic direction, technical leadership, and operational execution for all CMC development activities of...

  • Senior Director BIS G&A/CMC

    3 weeks ago

    Waltham, MA, United States Blackwomenintech Full time

    For the expansion of our BIS team, argenx is looking for a Senior Director BIS G&A/CMC. The Senior Director BIS G&A/CMC is the single point of accountability for strategy and implementation for all information, processes and systems to address the business needs and challenges of the CMC, Manufacturing, Supply Chain, Legal, Finance and Human Resources...

  • Regulatory Affairs Manager

    2 months ago

    Somerville, United States Gan & Lee Pharmaceuticals Full time

    Job DescriptionJob DescriptionSummaryThis position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain...

  • Regulatory Affairs Manager

    2 weeks ago

    Somerville, United States Gan & Lee Pharmaceuticals Full time

    Job DescriptionJob DescriptionSummaryThis position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain...

  • Regulatory Affairs Manager

    2 months ago

    Somerville, United States Gan & Lee Pharmaceuticals Full time

    Job DescriptionJob DescriptionSummaryThis position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain...

  • Research Scientist – CMC – Trauma Neuroscience

    2 weeks ago

    Somerville, United States Cambridge Health Alliance Full time

    CHA has a vibrant academic community with strong education, training and research programs. We are proud to have 700 providers on the faculty at Harvard or Tufts University School of Medicine. The Research Scientist will be responsible for developing his/her own independent research career and assisting with the day-to-day management of multiple research...

  • Research Scientist – CMC – Trauma Neuroscience

    2 weeks ago

    Somerville, United States Cambridge Health Alliance Full time

    CHA has a vibrant academic community with strong education, training and research programs. We are proud to have 700 providers on the faculty at Harvard or Tufts University School of Medicine. The Research Scientist will be responsible for developing his/her own independent research career and assisting with the day-to-day management of multiple research...

  • Senior Director, Drug Product

    2 months ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Senior Director, Drug Product (Technical Operations) position is a key leadership role responsible for antibody drug product development and manufacturing. The Senior Director, Drug Product is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer. This role provides the opportunity to...

  • Senior Vice President, Drug Design and Preclinical Development

    3 weeks ago

    Somerville, United States Generate Biomedicines Full time

    About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine...

  • Senior Vice President, Drug Design and Preclinical Development

    2 weeks ago

    Somerville, United States Generate Biomedicines Full time

    About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine...

  • Lead Teacher

    3 weeks ago

    Somerville, United States Community Action Agency of Somerville Full time

    Job DescriptionJob DescriptionJob Title: Lead Teacher (Preschool)Supervisor: Center Director/Education DirectorHours: 35-40 hours per weekSalary: $25.24/hr plus $2,000 hiring bonus and opportunities for additional bonusesFLSA: Non-ExemptStatus: Full-Time, Union OVERVIEWThe Community Action Agency of Somerville, known as CAAS, is changing lives for our...

  • Director/Senior Director, Analytical Development

    2 months ago

    Boston, MA, United States Scorpion Therapeutics Full time

    Job Description The position is responsible for technical leadership of analytical development within the CMC function across Scorpion’s portfolio. Analytical Development has responsibility for analytical activities from late-stage Discovery (lead optimization, development candidate nomination) through early-stage clinical development for small molecule...