Senior Manager/Associate Director, Quality Control
About Clade Therapeutics
Clade Therapeutics is a well-funded, early-stage cell therapy company developing novel cell-based medicines for the treatment of cancer and other devastating diseases. The company, located in Kendall Square, was recently founded by an exceptional group of academic leaders and successful bioentrepreneurs. The Company works at the convergence of stem cell biology, immunology, regenerative medicine, and gene editing to create the next-generation of stem cell-derived medicines.
We are passionate about delivering on the promise of cellular therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients.
We are looking for a Senior Manager of Quality Control to join our Clade Quality Team to lead the Quality Control group. The Senior Manager, Quality Control will have responsibility for the safety, compliance, development and continuous improvement of the QC organization at the Clade. Testing responsibilities include oversight of drug product, drug substance, in process, raw materials, investigational samples and product stability. The candidate is expected to effectively collaborate with key customers internally and externally (e.g. Research, Product Development, CMOs, and CTOs to strategically manage and prioritize testing plans and schedules. The candidate will partner with CMC and Regulatory Affairs to ensure timely and accurate responses to Health Authority questions and review of submissions supporting clinical products and ultimately commercial products. This individual will work with the QA leadership and peers at Clade to define the QC strategy and objectives. We are looking for someone who understands clinical development in an early-stage company, is not afraid to take risks, will work within the laboratory and collaborate cross-functionally. If you are interested in helping Clade achieve new milestones and continue to grow, this may be the role for you.
- Responsible for leadership of QC functions that include: Analytics, Raw Materials, Sample Management, Data Management, and Stability. Provide strategic and tactical leadership to the QC organization ensuring the execution of responsibilities within the Quality System.
- Ensure the testing of products is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGMPs as well as local Health and Safety requirements. In achieving this responsibility, assess local processes for compliance to Clade Standards and Regulatory Standards as they are updated and amended.
- Manage a team of 2-3 direct reports with potential for growth.
- Recruit, retain and develop QC talent responsible for the testing of drug substance, drug product, and raw materials in support of manufacturing operations.
- Develop performance objectives for QC and direct reports; monitor performance against objectives.
- Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve.
- Drive compliance throughout the function and represents QC during regulatory inspections.
- Write and/or review assigned CMC sections for new and amended regulatory submissions.
- Develop and maintain strong and effective relationships with stakeholders.
- Lead QC team in strategy and oversight for addressing laboratory and site investigations and reports in response to OOS, invalid assays, aberrant trends/results, and studies.
- Bachelor’s degree in Life Sciences or related field required; preference given to candidates with advanced degrees and degrees in Chemistry or a biological science.
- A minimum of 7-10 years of biopharmaceutical experience with accountability for cGMP QC Operations and Product Quality in a manufacturing plant.
- Thorough knowledge of cGMPs, EU/ICH and global regulatory requirements.
- A minimum of 2-3 years direct experience managing a Quality Control function and team members.
- Deep knowledge of regulatory requirements and current guidance documents for cell-based therapies and associated analytical testing in support of biopharmaceutical products/facilities.
- Planning and organizational skills are required to plan, execute and track commitments of the QC laboratory and to adjust to changing priorities.
- Good interpersonal skills, ability to influence and communicate well, both verbally and written
- Technical experience in flow cytometry, PCR and/or genetics analysis required.
- Experience in analyzing gene edited cells highly desirable.
- Patients First – Proactively and constructively engage to deliver results for those in need. “Begin with patient’s success in mind”
- Communication and Respect – Foster open exchange with colleagues and collaborators. Seek to understand and treat people with courtesy. “Better together”
- Integrity & Excellence – Act honestly and ethically to seek the truth. Courageously doing the right thing – take smart risks and make tough decisions in pursuit of exceptional outcomes. “Get it done right”
Clade Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, gender, age, religion, national origin, disability, veteran status, sexual orientation or any characteristic protected under applicable law.