Full-Time

Executive Director

Regulatory Science, CMC

Posted on 10/1/2024

Tessera Therapeutics

Tessera Therapeutics

201-500 employees

Develops gene editing technology for genetic medicine

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required, Ph.D. desirable.
  • Minimum of 16 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC‐focused regulatory science role.
  • Recent experience in successfully leading CMC‐related regulatory interactions, and in IND/CTA or BLA/MAA regulatory submissions and approvals.
  • Proven success in delivering effective global regulatory CMC strategies and in leading a regulatory CMC team.
  • Excellent written and oral communication and interpersonal skills.
  • Thorough understanding of CMC drugs and biologics regulations and guidelines including ICH, FDA and EMA guidelines. Strong knowledge of current Good Manufacturing Practices (GMP).
  • Being well-versed in regulatory and technical writing.
  • Retaining optimism and energy in the face of change and challenges; eagerness to problem‑solve and influence outcomes.
  • The ability to incorporate multiple viewpoints to create optimal strategy forward.
  • Being independently motivated, detail oriented and scientifically rigorous.
  • Experience as a hands-on, roll-up-the-sleeves-when-necessary leader who understands the need for involvement within a growing company environment while recognizing when to delegate and empower the team.
  • Prior subject matter expertise and work experience in a CMC technical role to develop advanced therapy or biologics preferred such as gene therapies, oligonucleotides, or biologics.
  • Experience in projects involving scale-up, comparability, and expedited pathways.
Responsibilities
  • Developing robust CMC regulatory strategies for all Tessera development programs and anticipating phase-appropriate and future commercial requirements, in close collaboration with Technical Operations and Quality colleagues.
  • Communicating CMC regulatory program strategies with functional heads and executive team members.
  • Leading discussions with regulatory agencies to resolve CMC issues as well as shepherding proactive interactions with regulators globally to refine CMC development strategies.
  • Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers; this will require a good understanding of the underlying science.
  • Providing regulatory CMC guidance to internal teams and leading cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
  • Assessing regulatory impact of proposed manufacturing process changes.
  • Tracking regulatory CMC commitments; managing on-going regulatory submissions and future reporting requirements, including annual reports.
  • Effectively building, maintaining, and motivating a high-performing regulatory CMC team- including hiring, developing, coaching, and mentoring a diverse, talented and driven staff.
  • Actively participate in building an outstanding regulatory team, leveraging operational excellence to efficiently implement innovative regulatory strategies.
  • Maintaining knowledge of global regulatory CMC environment and applicable regulations and guidelines. Leading reg-CMC intelligence activities.
  • Support Quality and CMC teams during GMP inspections.

Tessera Therapeutics focuses on genetic medicine, specifically through a technology called Gene Writing, which enables precise modifications to the human genome. This technology allows for permanent changes to genetic material in any cell, aiming to cure diseases at their source. Tessera's Gene Writing can perform both small and large genetic alterations, making it applicable to a wide range of genetic disorders. The company primarily serves research institutions, pharmaceutical companies, and healthcare providers seeking to develop new treatments for genetic diseases. Unlike its competitors, Tessera Therapeutics emphasizes the versatility of its Gene Writing platform, which can address previously untreatable conditions. The company's goal is to advance genetic medicine by rewriting the genetic code to cure diseases, supported by significant funding to further develop its technology.

Company Stage

Series C

Total Funding

$518.2M

Headquarters

Cambridge, Massachusetts

Founded

2018

Growth & Insights
Headcount

6 month growth

-8%

1 year growth

-10%

2 year growth

14%
Simplify Jobs

Simplify's Take

What believers are saying

  • Tessera secured $300 million in Series C financing in April 2022.
  • Partnership with Gates Foundation supports development of sickle cell disease treatment.
  • Increased interest in RNA-based therapies benefits Tessera's platform development.

What critics are saying

  • Potential competition from CRISPR-based gene editing technologies.
  • Regulatory challenges in obtaining approval for novel gene editing therapies.
  • Ethical concerns could impact adoption of Gene Writing technology.

What makes Tessera Therapeutics unique

  • Tessera Therapeutics is pioneering Gene Writing, a novel genetic medicine technology.
  • Gene Writing allows precise, permanent genome alterations, unlike traditional gene editing methods.
  • Tessera's technology can target a wide range of genetic disorders effectively.

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