ImmunoGen, Inc. DEVELOPMENT ASSOCIATE II/III, ANALYTICAL DEVELOPMENT in Waltham, Massachusetts
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 Technical Operations team as a Development Associate, Analytical Development. The successful candidate will be responsible for supporting analytical method lifecycle activities at contract testing laboratories (CTL) and contract manufacturing organizations (CMO) for late-phase antibody-drug conjugate (ADC) development. The candidate will support CMC activities to enable filing and commercialization of multiple ADC programs.
Supporting validations, re-validations, transfers, trending/monitoring, optimization, troubleshooting, etc. for large and small molecule methods (release, stability, and in-process control) maintained at CMOs and CTLs
Supporting reference standard management for small molecules and biologics, including qualification and re-qualification activities
Authoring and reviewing all documentation (protocols, reports, test methods) related to the activities above; collaborating closely with QA to ensure applicable requirements are met (GMP, ICH, compendial)
Authoring change controls for analytical-related changes and supporting deviation/excursion management
Authoring and reviewing regulatory filings (BLA, MAA, PAS), and drafting responses to questions from health authorities during review
Supporting specification setting (release and stability) for drug product, drug substance, and drug substance intermediates (monoclonal antibodies and small molecules)
Serving as analytical representative on CMC team and working closely with process development, formulation development, manufacturing sciences, quality assurance, regulatory CMC, and supply chain to support program objectives
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.
BS or MS in chemistry, biochemistry, or closely related discipline
At least 4 years of experience in analytical development or quality control supporting antibody or ADC therapeutics in a GMP environment
Strong knowledge of GMP requirements, ICH guidelines, and compendia (USP and Ph. Eur.)
Excellent verbal and written communication skills
Experience working with contract organizations (CTLs and CMOs) preferred
Experience with statistical software (e.g., JMP, Minitab) preferred
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 and annual restricted stock unit and stock option awards for all employees
3:2 office workday for flexible working arrangements
Stipends for learning opportunities
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.
Requisition ID: 2023-1546
External Company Name: ImmunoGen, Inc.
Street: 830 Winter Street