Overview

Work Location: US Headquarters, Waltham, MA (3 Days / Week in Office)

About the Role

Cancer doesn’t care how it disrupts the course of lives. We do. Since our founding, we have pursued one goal: develop targeted cancer therapies to improve outcomes for cancer patients. This singular focus has positioned us as a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer. At ImmunoGen, each of us is driven by a shared conviction that by advancing precise, targeted cancer therapies, we have the power to offer more good days to patients and their families ― now. It is why we come to work each and every day, and it is what will continue to motivate and energize us in the years to come.

ImmunoGen is currently looking for an individual to join our Quality Assurance Department. This position reports to the Associate Director Quality Product Testing and will oversee compliance of GMP activities for assigned Contract Testing Laboratories (CTL)/Contract Manufacturing Organizations (CMO) as it relates to QC testing of ImmunoGen products.

Responsibilities

• Partner with Analytical Sciences to ensure ImmunoGen products are tested using phase-appropriate qualified methods are assigned adequate release and stability specifications and expiry.
• Review and approve method transfer, qualification and validation protocols/reports and test methods to ensure compliance with applicable compendia, ICH guidelines and regulatory requirements.
• Audit Product Test Data Packages from CTL/CMO (Release, Stability, Reference Standard Qualification).
• Review and approve Lab Events, Deviation, or OOS related to Product Test Data Packages from CTL/CMO.
• Own change controls, quality events, and CAPAs related to product testing events per company procedures.
• Prepare/review stability data trend analysis and present to the Stability Review Committee.
• Author, review, and approve SOPs and policies related to QC activities, including management of stability data, expiry assignments, and product specifications.
• Document and communicate review metrics for assigned CMO/CTL (e.g., data integrity issues observed, untimely data package deliveries).
• Enter or verify/authorize stability data in SLIM (Stability Lab Information Manager)
• Perform related tasks as requested by management.

Life at ImmunoGen

At ImmunoGen, we are looking for forward-thinking talent with diverse experiences and a track record of success, leadership skills, a demonstrated ability to take initiative, and a passion for improving the lives of those living with cancer. To succeed here is to care ― care about what we do, why we do it, and each other. We are working hard to bring hope to our patients and their families, which inspires our teams to aim high and honor our commitment to continuous improvement.

At ImmunoGen, collaboration is not a construct. It is at the core of everything we do and shows up in how we work every day. Here, your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment; who can think about our future and see the promise before us; who anticipate risks and opportunities; who are willing to learn and adapt to change; who are inclusive and eager.

Together, we rise to the challenge before us, advancing our programs on the strength of our deep scientific and commercial expertise and energized by the opportunity to change long-standing treatment paradigms. We pride ourselves on the work that we do, and know that it is a privilege to work in the oncology space and to dedicate our days to helping patients.

Our Unique Opportunity

It’s an exciting time for our organization. The US FDA recently granted accelerated approval for ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, marking our transition into a fully-integrated oncology company. This is just the beginning, as we embark on an exciting new chapter as a leader in the development and commercialization of innovative oncology products.Joining ImmunoGen now will give you the unique opportunity to create a lasting impact ― to make your mark on the work that we are doing by leveraging your experience to shape our first commercial launch and the go-forward organization.

Qualifications

• BS/MS in Chemistry or a closely related discipline
• Minimum 8 years of relevant GMP experience in the biotechnology or pharmaceutical industry.
• Prior experience with analytical method development and validation for small molecules and biologics/biopharmaceuticals. Experience with ADCs preferred.
• Prior experience with GMP and regulatory requirements for lab controls, stability, reference standards, and data integrity.
• Experience analyzing critical data and proactively solving problems.
• Working knowledge of quality processes, deviations, OOS investigations, change controls, and lab events.
• Knowledge of GMP and regulatory requirements for clinical and commercial products (USA and EU).
• Training and experience in statistical analysis and GMP databases (e.g., LIMS, SLIM) are pluses.
• Excellent technical writing, analytical, and verbal skills.
• Strong work ethic along with solid organizational, time, and program management skills.
• Results Oriented: Establishes clear goals and expectations and effectively allocates resources. Consistently delivers. Has flexible and creative problem-solving skills.
• Strategic Thinker: Is able to see the big picture and understand the challenging and sometimes conflicting needs within an organization. Thinks logically, develops and evaluates options, and identifies pros and cons. Constantly strives for ways to add value and improve how work is done.
• Self-directed: Able to work effectively with limited direction in a complex, fast paced environment.
• Positive Energy: Brings energy into the room and is a strong collaborator.
• Patient Focus: Work with urgency and go the extra mile.
• Willingness to travel (domestic and international) <10%

Our Benefits

We believe in the potential of our people and foster a supportive environment that develops our folks, rewards performance, and incentivizes long-term success. From excellent benefits and competitive compensation to ownership in the company, we want to inspire our employees.

Our benefits include, but are not limited to:

• Competitive salary and bonus plans
• Top-tier health, vision, dental, and life insurance
• Generous paid holidays, time off, and parental leave
• Comprehensive package of benefits plans
• 401K Retirement Savings plan offering a company matching contribution
• New Hire Equity for all employees
• Tuition reimbursement
• 3:2 office workday for flexible working arrangements
• Stipends for learning opportunities

About ImmunoGen

ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™. Learn more about who we are, what we do, and how we do it at www.immunogen.com.

At ImmunoGen, targeting a better life for people with cancer is what we do, and we believe that a diverse and inclusive team is essential to achieving this. We strive to create a workplace that reflects the communities we serve and where everyone feels empowered to bring their full, authentic selves to work. There is work to be done and with the help of our entire team — our employees, customers, partners, and community — we can deliver more good days to those who need them most.

ImmunoGen is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

ImmunoGen does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen's approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen by search/recruiting agencies not already on ImmunoGen’s approved agency list shall become the property of ImmunoGen and if the candidate is subsequently hired by ImmunoGen, ImmunoGen shall not owe any fee to the submitting agency.

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