Associate Director, External Manufacturing and Supply Chain
Associate Director, External Manufacturing and Supply Chain
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Description
Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Job Type
Full-time
Description
Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Marengo is driven by core values that guide our company’s mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of thinking with curiosity and imagination. With an exciting journey ahead and a tremendous opportunity for growth, now is the time to join the Marengo team and impact cancer patient care – are you ready to join the new frontier?
To learn more, visit marengotx.com.
Associate Director External Manufacturing and Supply Chain
About the Role:
We are seeking an innovative and driven Associate Director to oversee our external manufacturing and supply chain operations. In this pivotal role, you'll ensure that our cGMP technical operations run smoothly and effectively support Marengo's expanding clinical development portfolio. With your expertise, you'll develop and execute manufacturing plans that align with our dynamic program strategies, keeping us on time and on budget. This is an incredible opportunity for growth and development at a cutting-edge biopharma company dedicated to discovering and delivering novel medications to patients in need.
Who are we looking for?
- Experienced Leader: You have broad experience in clinical-stage CMC operations, with demonstrated technical expertise and successful collaboration with internal/external partners.
- Creative Thinker: You thrive on challenges, eager to think outside the box and push boundaries in biopharma innovation.
- Excellent Communicator: You articulate ideas clearly and effectively, building trust with stakeholders at all levels.
- Collaborative Team Player: You work seamlessly across various functions—clinical operations, quality, program management, finance and more—to drive projects forward.
- Adaptable Professional: You can pivot in a fast-paced environment, eager to learn and grow with the company, with the ability to determine task priority and maintain established deadlines.
What are we offering?
- Collaborative Culture: Be part of a caring and collegial community focused on innovation and shared success.
- Impactful Work: Engage with a passionate CMC team and contribute to groundbreaking science that helps patients in need.
- Growth Opportunities: Access to professional development and the chance to help shape the future of our CMC function.
Key Responsibilities:
- Provide end-to-end operational oversight and technical support to CMOs, ensuring compliance with Quality and Regulatory standards.
- Align strategic planning and manufacturing schedules with clinical trial designs and demand forecasts.
- Lead documentation authoring/review and change management efforts, proactively addressing deviations, complaints, and investigations as they arise.
- Ensure supply chain continuity through proactive management of global material transportation and storage logistics for cell banks, Drug Substance/Product, and Finished Goods.
- Conduct audits and performance reviews of external manufacturing facilities.
- Manage project timelines, budgets, and supplier contracts while identifying risks and contingency plans.
Requirements
Education and Experience:
- Advanced Degree in Biochemistry, Biotechnology, Chemical Engineering, Pharmaceutical Sciences or a related field.
- Minimum of 7+ years of progressive, relevant experience in protein biologics CMC operations.
- Broad technical depth of knowledge in areas including cGMP cell banking, cell culture, purification, fill/finish, clinical pack/label, in-process/release/stability testing, and material logistics.
- Track record of successfully executing CMC and supply chain strategies from pre-IND through clinical cGMP manufacturing.
Preferred Skills:
- Experience with clinical manufacturing of multi-specific/fusion molecules
- Detailed knowledge of product development and life cycle management
- Ability to adapt to shifting priorities, demands, and timelines
- Effective collaboration with cross-functional teams, external vendors and CMOs
- Strong project management, communication, collaboration, and problem-solving skills
- Experience progressing CMC from clinical to commercial stage
Competencies:
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, called Cambridgeport):
We are only considering candidates who are local to our headquarters in Cambridge, MA, as this role requires regular on-site presence
When You Join Marengo, You Will Have:
A competitive salary based on your experience before joining Marengo. In addition to the compensation, we offer the following benefits:
- Free parking, Cambridge location reachable by public transportation (Red Line)
- Customized and competitive health coverage, including medical offered through BCBS (HMO/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, and parental leave
- 20 days of vacation and one personal day, and 64 hours of sick time per year, in addition to 16 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.
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Management and ManufacturingIndustries
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