Quality Product Manager Jobs

Work Location: US Headquarters, Waltham, MA (3 Days / Wee k 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 team. Under the direction of the Director of Quality Assurance, ensure end-to-end product quality for designated products. This encompasses all aspects associated with manufacturing and testing of designated product(s) components (antibody, payload and linker), drug substance and drug product. Provide Quality oversight to ensure manufacturing and testing is conducted in compliance with all applicable filings, regulations and cGMPs. Serve as the primary Quality representative and product quality expert for designated product(s) in relevant forums including CMC teams and Supplier Relationship Teams.
Responsibilities

• Partner with relevant teams to highlight potential quality issues during development, manufacturing and testing and identify/execute strategies to effectively manage them.
• Collaborate with key CMC stakeholders on development of the overall control strategy (e.g., in-process, release, stability testing and respective acceptance criteria (i.e., limits)). Approve the sampling and test plan that defines the testing requirements at each manufacturing step.
• When establishing a new CMO or CTL, serve as a member of the assessment team to determine if the prospective supplier has the necessary and sufficient quality system capabilities to ensure product quality.
• Lead the risk management process for designated product(s). This includes the conduct of quarterly risk assessment reviews, creation of a relevant risk reduction plan, track progress of actions to mitigate risk and justify acceptance of residual risk. Partner with other Quality Product Steward(s) to assess risk at the CMO/CTL level.
• Review and approve process validation protocols and reports, as well as master batch records for use by CMO and partners.
• Monitor compliance to respective Quality Agreements and escalate issues to respective Supplier Relationship Manager and senior management, when necessary.
• Assist in the disposition all batches of antibody, payload, linker, drug substance and drug product.
• Acquire and maintain end-to-end product knowledge enabling a contextual understanding of designated product(s) from development through current day.
• Coordinate development of Annual Product Reviews and FDA metrics for designated product(s) and ensure completeness including lifecycle management commitments.
• In partnership with SMEs from Technical Operations , review trended product data (as prescribed by the designated product(s) monitoring plans) and assess impact of process changes and effectiveness of CAPAs and change controls on product quality.
• Review and approve all relevant change controls, deviations, investigations and associated CAPAs.
• Participate in Stability Review Committee and Specification Review Board meetings. Review/Approve product specifications.
• Lead complaint investigations and recalls, as necessary.

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
Basic Qualifications

• Knowledge of cGMP and regulatory requirements for ADC manufacturing and testing.
• Self-directed: Able to work effectively with limited direction in a complex, fast-paced environment.
• Preferable to have experience working with third party manufacturers.
• BS/MS in relevant scientific or engineering discipline.
• Demonstrated effectiveness in problem solving, decision making and managing a diverse set of activities across multiple stakeholders.
• Results Oriented: Establishes clear goals and expectations and effectively allocates resources. Consistently delivers. Has flexible and creative problem solving skills.
• Positive Energy: Brings energy into the room and is a strong collaborator.
• Ability to travel, as required, to support partner execution.
• Communications: Strong, clear communicator who recognizes that new ideas and approaches require a great deal of communication. Able to communicate across functions and bring people together around a common goal.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• 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.
• Preferable to have experience in both small molecules and biologics, as well as involvement in process development of ADCs.
• Demonstrated effectiveness in partnership relationships in the areas of communication, influence and negotiation.
• Must be able to talk, listen and speak clearly on telephone
• Minimum of 8 years of relevant experience in the pharmaceutical industry, including time spent in a Quality role in a GMP environment.
• Working knowledge of batch release processes and associated accountabilities (assessment of batch data, deviations, investigations, change controls, complaints, etc.).
• Innovation: Drives and supports new ways of thinking and embraces change.
• Team Leader: Able to manage, lead, and nurture talent. Encourages team to present and debate their best ideas and holds the team accountable for results.
• Patient Focus: Work with urgency and go the extra mile. The patient is waiting
• Must be able to lift and carry up to 10 lbs

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

• Company matching 401K and retirement savings plans
• Comprehensive package of benefits plans
• Generous paid holidays, time off, and parental leave
• Stipends for learning opportunities
• Tuition reimbursement
• New hire and annual stock option awards for all employees
• Competitive salary and bonus plans
• Top-tier health, vision, dental, and life insurance
• 3:2 office workday for flexible working arrangements

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