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
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.
- Reviews batch documentation and dispositions materials for use in clinical trials
- May lead & manage strategic GMP QA activities associated with Tango CMC development programs
- Ensures compliance with regulations related to manufacturing, testing, packaging & distribution of investigational drug product and investigational active pharmaceutical ingredients. Identifies compliance gaps and proposes solutions
- Will execute and lead other staff to implement robust Phase-Appropriate guidance/review/approval for Product Development projects in Phase 1, 2 and 3
- Independently manages projects & makes sound decisions related to product quality issues
- Identifies any trends related to development compounds, operations, etc.
- Ensures timely submission of GMP-related documentation and archival
- May participate in GMP quality audits of vendors as necessary. Make recommendations to management concerning use of vendors based on audit findings
- Support team members regarding best practices in GMP document and records compliance
- Additional duties and responsibilities as required
What You Bring:
- Bachelor's Degree in Chemistry, Biology, Engineering or related field plus 8 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
- Comprehensive knowledge of international GMP regulations and subsequent applications to pharma drug development
- Experience in QA of drug product through the lifecycle of pharmaceutical product development
- Thorough understanding of creation/ review/approval of GMP documents such as specifications, test methods, stability protocols, batch records, and investigations
- Demonstrated teamwork, initiative and problem-solving skills
- Strong oral/written communication skills
- Demonstrated project management 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.
- Excellent attention to detail and organizational skills are critical
- Ability to regularly work collaboratively with other team members
- Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
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.