Company Overview
Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.
This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
Summary
This role will report to the Director of Quality and operate across departments, supporting regulated activities and studies. This new role will support CMC development and clinical disposition activities for Tango’s development programs. Tango works in a matrixed, outsourced model where compliance and inspection readiness are key to our programs as we advance through the development cycle.
The Manager, Quality Assurance will provide GMP QA oversight for Tango’s CMC development programs and clinical supply activities. This role partners cross-functionally with Technical Operations, Regulatory, and external manufacturing partners to ensure compliance with global GMP requirements while supporting the advancement of investigational therapies through clinical development.
Your Role:
- Review batch documentation and dispositions materials for use in clinical trials
- Lead & manage strategic GMP QA activities associated with Tango CMC development programs
- Ensure compliance with regulations related to manufacturing, testing, packaging & distribution of investigational drug product and active pharmaceutical ingredients. Identify compliance gaps and propose solutions
- Execute and lead implementation of phase-appropriate quality guidance, review, and approval processes for product development programs across Phases 1–3
- Oversee projects independently, identifying, evaluating, and resolving product quality concerns in compliance with GMP requirements
- Identify trends related to development compounds, operations, etc.
- Ensure timely review, approval, and archival of GMP documentation and quality records
- Participate in GMP audits of CMOs, contract laboratories, and other vendors, providing recommendations regarding vendor qualification and continued use
- Mentor and support internal teams on GMP documentation, quality practices, and regulatory compliance
- Additional duties and responsibilities as assigned
What You Bring:
- Bachelor's Degree in Chemistry, Biology, Engineering or related field plus 5 years pharma manufacturing, packaging or laboratory experience
- At least 5 years of direct QA/compliance experience working in biotechnology, pharmaceutical, laboratory, CRO or CMO environment
- Strong knowledge of global GMP regulations (FDA, EMA, ICH) applicable to investigational drug development
- Experience providing QA oversight of drug product development across the pharmaceutical lifecycle Thorough understanding of creation/ review/approval of GMP documents such as specifications, test methods, stability protocols, batch records, and investigations
- Ability to collaborate effectively in a matrixed, cross-functional, and global environment
- Strong oral/written communication skills
- Capable of analyzing a wide variety of information and data to make management decisions regarding potential risks associated with product quality or regulatory compliance
- Able to establish professional relationships and rapport with internal and external peers and experience working collaboratively with teams in a complex, matrixed and global environment
- Strong attention to detail and commitment to maintaining high quality and compliance standards
- Strong project management and organizational skills, with the ability to manage multiple concurrent priorities
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Top Skills
What We Do
Tango Therapeutics is a biotechnology company discovering and developing novel medicines targeting cancer vulnerabilities to deliver transformational new therapies for patients. Tango was launched in 2017 with a $55 million Series A investment from Third Rock Ventures. The company has established a robust product engine that leverages advances in DNA sequencing and CRISPR-based target discovery to generate breakthrough medicines that have the potential to provide deeper, more sustained benefit than today’s targeted therapies, and extend the benefit of available immuno-oncology agents. Tango Therapeutics is focused on three areas of drug development, each in well-defined patient populations currently lacking effective treatment options, and each with hallmarks of cancer that have not been targeted yet. These include: loss of tumor suppressor gene function; multiple oncogenic drivers; and immune evasion. What fuels each of Tango’s programs is an increasingly sophisticated ability to utilize synthetic lethality - the interaction between two genes that causes cell death when both are inactivated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. This approach leaves normal cells largely unaffected, with the potential to greatly enhance anti-tumor efficacy and reduce associated toxicity. Tango’s success will be driven by its depth of understanding of the genetic subtypes of cancer, and corresponding insights into novel drug targets and combinations uniquely relevant to each subtype. By shaping discovery efforts in this way, Tango has the potential to reach the clinic quickly, and with a clear plan for identifying the patients most likely to benefit from each new treatment, an approach that could increase both speed and probability of success in translating novel target discoveries into transformational new medicines for patients.
