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Stealth BioTherapeutics
Massachusetts, United States
30+ days ago
Stealth BioTherapeutics
Massachusetts, United States
30+ days ago

Description

Position Summary:
The Vice President (VP), Pharmaceutical Sciences and Technical Operations (PSTO) will be
responsible for leading and executing all CMC (Chemistry, Manufacturing and Controls)
and related activities from IND-enabling studies to NDA. S/he will be responsible for the
development and implementation of efficient and effective CMC strategies to ensure
excellent process and product development, including controls, in compliance with
regulatory guidance.
The ideal candidate will be a highly motivated individual with substantial CMC experience
in developing drugs from small organic drug substances, as well as have experience with
therapeutic peptides. S/he will derive motivation from working in a small, entrepreneurial
biotech environment, accepting the challenge of broad responsibilities and opportunities
in a lean, matrix-focused can-do culture. A “hands-on” operational approach in a virtual
biotech combined with the ability to effectively meet development and manufacturing
objectives through contractors addresses a core responsibility.


Responsibilities:
• Develop and implement a sustainable and adaptable CMC strategy for each clinical
candidate. Lead CMC activities from IND-enabling studies to late clinical development,
ensuring full executive management engagement in key decisions and effective
communications to all stakeholders.
• Build or adapt the operational tools, systems, and communication channels necessary
for alignment of the PSTO department with program teams, as well as finance and legal
practices, to achieve the goals and objectives of the Company.
• Provide input into the regulatory affairs strategy for the product portfolio; lead the
development, review, and approval of all CMC sections in regulatory filings. Participate
in meetings with the relevant global health authorities, conveying the appropriate
compliance with GMP and other standards.
• Through Contract Manufacturing Organizations (CMOs), Contract Testing
Organizations (CTOs), Contract Research Organizations (CROs), meet the needs of
internal customers for appropriately packaged and labeled clinical supplies and, where
applicable, commercial goods.
• Oversee the 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 for the development of drug substances and drug
products.
• Lead, coach, mentor and further develop the PSTO team of scientists and managers
and ensure alignment between individual, departmental, and corporate goals.
• Proactively identify potential risks to CMC timelines and deliverables and
communicate/implement effective risk mitigation strategies.
• Directly manage external subject matter experts in the areas of CMC regulatory
strategy, pharmaceutical development and manufacturing, and analytical development.



Requirements

Requirements and Competencies:
• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related technical
discipline, as well as a minimum of 15 years’ experience in the Biotech/Pharmaceutical
industry, with 10+ years managing a CMC function. Small, virtual biotech experience
preferred.
• Demonstrated ability to create and execute strategies for successful product.
development through effective management of CMOs/CROs/CTOs.
• Substantial experience with cGMP manufacturing and testing of pharmaceuticals from
early clinical development through product/process validation.
• Knowledge of cGMP regulations and CMC-relevant ICH guidance documents as well as experience in the preparation of CMC regulatory documents. Experience with pre-
approval and other cGMP inspections and audits a plus.

• Strong proficiency in use of software to meet the key communication and data analysis
and presentation objectives of the CMC function.

• Demonstrated general ability to apply fundamental scientific and engineering know-
how to generate innovative and practical solutions to technical challenges.

• Skilled in clearly conveying complex concepts and study results in written and verbal
form to a range of audiences, such as executive management, regulatory agencies, and
intellectual property attorneys.
• Highly motivated self-starter with strong interpersonal skills, including experience in
using influence and negotiation to successfully complete projects dependent on
collaborators.
• Ability to manage and simultaneously advance multiple tasks and projects and “flex”
between strategy and operational execution.

Job Information

  • Job ID: 63480814
  • Location:
    Massachusetts, United States
  • Position Title: Vice President, Pharmaceutical Sciences and Technical Operations
  • Company Name For Job: Stealth BioTherapeutics
  • Job Function: Pre-Clinical
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Ph.D.
  • Min Experience: Over 10 Years
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

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