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Full-Time

Executive Director

Regulatory Science, CMC

Confirmed live in the last 24 hours

Tessera Therapeutics

Tessera Therapeutics

201-500 employees

Develops gene editing technology for genetic medicine

Healthcare
Biotechnology

Senior, Expert

Cambridge, MA, USA

Category
Genomics
Biology Lab & Research
Biology & Biotech
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.
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, utilizing a technology called Gene Writing to make precise changes to the human genome. This technology allows for permanent alterations to genetic material in any cell, which can potentially cure diseases at their source. The Gene Writing platform can perform both small and large genetic modifications, making it applicable to a wide range of genetic disorders. Tessera Therapeutics collaborates with research institutions, pharmaceutical companies, and healthcare providers to develop new treatments for genetic diseases. Unlike many competitors, Tessera's approach emphasizes the ability to address previously untreatable conditions through its proprietary technology. The company's goal is to advance the development of Gene Writing to ultimately cure diseases by rewriting the genetic code.

Company Stage

Series C

Total Funding

$581.7M

Headquarters

Cambridge, Massachusetts

Founded

2018

Growth & Insights
Headcount

6 month growth

-10%

1 year growth

-6%

2 year growth

21%
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Simplify's Take

What believers are saying

  • Tessera's innovative Gene Writing technology has the potential to cure previously untreatable genetic conditions, offering a transformative impact on healthcare.
  • The company's strategic partnerships and licensing agreements with major pharmaceutical firms and research institutions can drive significant revenue growth and market penetration.
  • Recent leadership appointments, including a new General Counsel and Chief Regulatory Officer, bring extensive industry experience that can guide the company through regulatory and commercial milestones.

What critics are saying

  • The highly competitive biotechnology sector requires continuous innovation to maintain Tessera's market position.
  • Regulatory hurdles and the complexity of clinical trials for genetic therapies could delay product development and commercialization.

What makes Tessera Therapeutics unique

  • Tessera Therapeutics' Gene Writing technology offers a unique capability to make precise and permanent genetic alterations, setting it apart from traditional gene editing methods.
  • The company's focus on a wide range of genetic disorders, from phenylketonuria to sickle cell disease, showcases the versatility and broad applicability of its platform.
  • Securing $300 million in Series C financing highlights strong investor confidence and provides substantial resources for advancing their groundbreaking technology.