Title: VP Quality
Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and other diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, Marengo’s proprietary Selective T Cell Activation Repertoire (STAR) platform leverages an extensive biological understanding of T cell function and receptor signaling to create a world in which everyone’s immune system can defeat cancer. To learn more, visit marengotx.com.
STAR0602 is Marengo’s lead program, the first selective T cell activator generated from Marengo’s STAR platform; a library of antibodies targeting non-clonal variable (V)ß regions of the TCR fused to different co-stimulatory moieties. STAR0602 selectively targets a common Vb T cell subset present in all cancers and, by combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule, promotes expansion of a new population of clonally enriched, effector memory Vb T cells that turbo-charge immune system and promote a durable anti-tumor immune response. STAR0602 has undergone extensive preclinical testing, which demonstrates potent anti-tumor activity in both mouse and human ex vivo tumor models attributed to a distinct mechanism of action from existing cancer immunotherapies.
Role: VP Quality
Purpose of the role:
Reporting to the Chief Development Officer, this position plays a key strategic leadership and management role for Marengo’s Quality organization. Vice President, Quality is responsible for establishing, enhancing, and managing the quality and compliance activities within Marengo and across a network of outside contractors (CRO, CDO, CMO) accountable for the development, ongoing manufacturing, and eventual commercialization of Marengo’s products. This role will be responsible for defining the strategy for product quality management at Marengo across both early-stage and late-stage clinical products. The primary responsibilities of the position are to prepare the company for inspection and later commercialization while simultaneously developing and refining quality systems and building/leading a small organization to prepare for inspection and oversee product quality at all 3rd party contractors while ensuring high levels of quality and service to internal customers, positive experience of staff, and meeting departmental initiatives. The ideal candidate for this role is an experienced, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and who can communicate effectively with executive leaders and key leaders from external partners and customers.
Who are we looking for?
· You are an energetic and passionate quality professional who likes to think outside of the box, challenge the norm, and is passionate about the company’s mission of discovering and developing new medications
· You are a resourceful self-starter and team player with a strong result orientation
· You consider yourself a guru in all the corporate quality (GxP) in a clinical-stage organization
· You can develop trusting relationships to gain support and achieve results at all levels of the organization
What are we looking for?
· A driven professional who knows how to work and contribute to an ever-changing working environment
· A collegial individual who enjoys working in close collaboration with leaders in the research, development, quality, clinical, and administrative areas of the company
· A willingness to learn new things, adapt to new ways and go with the flow
· A person who thrives in a small company atmosphere
· Ability to determine task priority and maintain established deadlines
What are we offering?
· Membership within a growing, CARING, and collegial organization
· Being part of a passionate, involved, and cutting-edge Development Team
· Exposure to pioneering science and the discovery of drugs to help treat patients with cancer
· Enhance and mature the vision for corporate quality at Marengo as an emerging biotech. Act as a key strategic driver in integrating the role of quality into the business with the Executive Leadership Team (ELT).
· Lead a cross-functional group and establish an industry standard quality system that supports preclinical to commercial phase programs and products ensuring GxP compliance.
· Collaborate with internal functions and align goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP, and GLP compliance and realization of other value-added guidelines and best practices.
· Develop and oversee the development of a nimble, risked-focused quality system architecture that can flex across different clinical stage products, risk profiles, and sources/CMOs via continued improvements in Quality Systems to reduce complexity; improve effectiveness, efficiencies, and productivity, supporting sustainability and harmonization. Develop a roadmap for inspection and execute key activities needed to achieve business goals.
· Drive Quality by Design (QbD) initiatives into product development to help enable best practices in building manufacturable products.
· Represent Marengo quality in all partner/customer interactions.
· Interfaces directly with the FDA, EMEA, and other regulatory authorities, ensuring the company is appropriately represented in communications with the health authorities.
· Define quality policy and cross-company RACI matrix. Develop a best-in-class program for supplier management and auditing, as well as internal audit management.
· Oversee and provide ongoing management of the Quality Document Control and the sourcing, design, and implementation of a comprehensive Quality Management system to support critical drug development activities as well as our vendor relationships with external CROs or CMOs.
· Enhance, drive, and report on the CAPA/OOS/OOT and investigations programs.
· Accountable for the development of QA departmental budgets supporting the corporate and departmental goals and objectives and responsible for controlling the budget during the fiscal year.
· Mature the quality governance system that tracks the business with internal and external KPIs and holds departments/CXOs accountable for deliverables.
· Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
· Monitor, communicate, and act on any emerging compliance trends that may potentially impact product quality. Oversees function product issues and commits resources to understand root cause root and appropriate corrections.
Education and Experience:
- Bachelor's degree in a scientific discipline (Biology, Chemistry, Engineering), MS/Ph.D. would be an additional attribute but not mandatory requirement
- 15+ years minimum experience in the Quality/Supplier Quality field in life sciences, pharma, or biotech, including 10 years in leadership roles in increasing responsibility
- Excellent working knowledge, understanding, and experience with the practical implementation of FDA and EMEA (or equivalent) regulations and guidelines in GLP, GCP, and GXP environments.
- Successful experience with FDA, EMA, other regulatory bodies, and/or equivalent regulatory inspections, audits, and/or due diligence. Global experience is required.
- 8+ years’ experience in a senior/direct-line position at an organization that underwent PAI and/or regular audits by customers/regulatory agencies required.
- The candidate should be capable of operating with a high level of autonomy but get into the operational details as required. This is a strategic but “hands-on” role.
Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.
Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.
Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high-quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.
Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.
Location: Cambridge, MA (We are located in Lower Cambridge)
When You Join Marengo, You Will Have:
• Free parking, Cambridge location reachable by public transportation (Red Line)
• Customized and competitive health coverage, including medical offered through BCBS (PPO), dental, and vision
• Flexible Spending Accounts for medical and dependent care expenses
• Eligible from the first day for 401K, no matching
• A robust package of Marengo-paid insurance coverage, including life insurance, short-term and long-term disability
• 20 days of vacation and one personal day per year, in addition to 13 company holidays
TO ALL AGENCIES: Please, no phone calls or emails to any employee of Marengo about our openings. All resumes submitted by search firms/employment agencies to any employee at Marengo via email, the internet or in any form and/or method will be deemed the sole property of Marengo unless such search firms/employment agencies were engaged by Marengo for this position and a valid agreement with Marengo is in place. In the event a candidate who was submitted outside of the Marengo agency engagement process is hired, no fee or payment of any kind will be paid.
Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.