Manager/Senior Manager, CLIA and GxP Quality
- Employer
- Acrivon Therapeutics
- Location
- Watertown, Massachusetts
- Start date
- Jan 16, 2025
View more categoriesView less categories
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
Acrivon (NASDAQ: ACRV) is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner. These distinctive capabilities enable AP3’s direct application for drug design optimization for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates. Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a registrational-intent Phase 2b trial across multiple tumor types. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. Acrivon’s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The company reported positive clinical data for ovarian and endometrial cancers in April 2024, and in September 2024 it reported additional positive clinical data for endometrial cancer, including a confirmed overall response rate of 62.5% (95% CI, 30.4 - 86.5) and further validation of its prospective OncoSignature selection of patients predicted sensitive to ACR-368 by showing segregation of responders in OncoSignature-positive versus OncoSignature-negative patients (p = 0.009). The median duration of treatment was not yet reached, but the duration on study was 6 months at the time of the data cut.
In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target.
Acrivon has developed AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs.
Our global team operates out of two leading life science clusters, Watertown, MA and Medicon Village in Lund, Sweden.
Position Overview:
This position will play key role in the Acrivon Quality and Compliance department and will have responsibilities for day-to-day management of the clinical laboratory (CLIA) QMS and participate in select GxP quality functions.
Location:
This position will report to the VP, Quality and Compliance and be based out of the corporate headquarters in Watertown, MA.
Duties and Responsibilities:
- Development and quality management of the Acrivon CLIA lab.
- Day-to-day management of the electronic Part 11 compliant QMS (Training, Document Control, etc.) for the CLIA laboratory
- Lead efforts to analyze internal metrics, identify, and characterize issues, determine root cause, and plan improvement activities for the CLIA laboratory.
- Responsible for training activities (including curriculum development) and SOP generation in the CLIA laboratory.
- Leads in CLIA/CAP preparation and standardization efforts.
- Ensures compliance with licensing requirements.
- Monitor for emerging clinical laboratory regulations and evaluating regulations for impact to Acrivon.
- Contribute to development of key quality related laboratory metrics including the generation of routine and ad hoc reports.
- Participate in overall Departmental efforts to analyze internal metrics, identify, and characterize issues, determine root cause, and plan improvement activities.
- Risk assessment and analysis.
- Regularly participates in multi-discipline projects as GxP expert.
- May mentor colleagues and be viewed as a GxP quality and compliance leader/mentor.
- Monitor internal Quality Assurance and Quality Control (QAQC ) activities, including the design of standard operating procedures, method detection limits and data quantification; assure documentation and quality assessment of laboratory functions.
- Review quality systems for general compliance with the laboratory QA manual and certification/compliance requirements.
- Update quality systems when necessary, working with lab management to address issues of non-compliance and to identify and implement necessary improvements.
- Collaborate with staff to document regulatory compliance and use data collection tools to assess compliance with regulatory and accrediting agency standards.
- Assist with monitoring and coordinating documentation for proficiency testing programs.
- Serve as Laboratory Safety Officer, providing guidance and direction to ensure that overall safety and security standards are followed and amended in response to federal and state regulations, audits, or other directives.
- Maintain documentation and assist with implementation of staff education, including safety and security, follow-up of incident reports/corrective action reports, and quality assurance.
Required Skills/Abilities:
- Minimum of B.S. in a scientific area
- Minimum of five years of CLIA quality clinical diagnostic laboratory experience including CLIA lab management experience and prefer (although not required) experience in GxP quality areas.
- Academic and practical/working knowledge of CLIA/CAP, and NYS CLEP.
- Experience with audit/inspection certifications inclusive of preparation, host, and support roles, conducting root cause investigations, and CAPA through to confirming effectiveness.
- Acrivon prefers the candidate have experience (although not required) in at least two GxP disciplines with experience regarding the regulatory and compliance aspects associated with those disciplines. GxP disciplines in scope include GCP, CDx, CSV/IT, GLP, GMP, and PV.
- Advanced subject matter expert in the relevant technical and regulatory areas.
- Serves as quality expert within job function.
- Has conceptual understanding of all applicable functions and business areas.
- Considers and incorporates required compliance, regulatory and quality perspectives, and requirements into daily and ad hoc work projects.
- Demonstrates adaptability.
- Effective written and verbal communications.
- Express self clearly and accurately in written and verbal form.
- Balances diplomacy and respectfulness with assertiveness.
- Drives execution.
- Focuses on achieving objectives within specified timeframe and to meet quality expectations.
- Fosters teamwork.
- Ability to participate constructively on cross-functional and diverse teams.
- Willingness and ability to identify and investigate areas of potential risk.
- Promotes open communication and can build consensus.
- Ability to leverage negotiation and conflict management skills in appropriate situations.
- Ability to use critical thinking when problem solving.
- Ability to transition from strategic thinking to operational execution.
- Engagement planning and management toward timely and quality completion of objectives.
- Training and coaching skills.
- Ability to lead cross functional and diverse teams and participate constructively in multi-discipline teams.
Acrivon Therapeutics is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation, or genetics. In addition to federal law requirements, Acrivon Therapeutics complies with applicable state and local laws governing nondiscrimination in employment.
Company
Acrivon is a clinical stage oncology company leveraging our unique precision medicine platform, called Acrivon Predictive Precision Proteomics (AP3), for development of our drug pipeline. AP3 is used to generate proprietary OncoSignature® companion diagnostics to identify the patients who will benefit from our medicines.
The name Acrivon (derived from Greek for “accurate”) embodies how our OncoSignature® tests link the patient’s active tumor-driving mechanisms with the drug’s mode-of-action to accurately match our therapies with patients who will benefit independent of underlying genetic tumor alterations. Our pipeline includes the advanced Phase 2 lead program, ACR-368 (prexasertib), a clinically active CHK1/2 inhibitor, as well as preclinical programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation.
Acrivon’s team is a rare blend of leading scientific pioneers and highly accomplished executives. The team is located at two Centers of Excellence in Boston and Lund/Copenhagen in Scandinavia leveraging regional expertise, infrastructure, and capabilities.
In addition to learning from some of the field’s greatest minds, our committed team members are encouraged to realize their full potential in work and life. We’re a passionate group that values openness, creativity, fresh perspectives, transformative ideas, and a positive can-do attitude. We value diversity, integrity, and passion for scientific excellence, and care deeply about our patients.
If you have the drive and passion to build the future with us, please see our current open positions.
- Website
- https://acrivon.com/
- Location
-
480 Arsenal Way
Watertown
MA
02472
US
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