QUALITY GxP SYSTEMS ANALYST
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 department in a GxP Systems Analyst role.
Responsibilities
- Responsible for the maintenance, configurations, and reliable operation of TrackWise Digital, Veeva Vault Instances and related GxP systems or applications.
- Troubleshoot common software errors.
- Documenting and prioritizing problems and assessing impact of issues and resolutions.
- Provide customer support to system users; work with vendor customer support to resolve problems in a timely manner; create reports and dashboards as needed.
- managing user accounts and executing administrative change requests.
- Support computer system validation activities, as needed.
- Includes identify user requirements, execute validation protocols, and ensure validated state of systems.
- Work cross functionally with Quality Assurance, Information Technology, Validation, and core system users.
- understand the needs and system requirements of the business units to recommend process improvements.
- Create Change Controls and write up as needed.
- Provide routine updates to SOPs and Work Instructions of GxP systems.
- Assist in organizing project deliverables and coordinating project meetings.
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
- BA/BS Degree in Computer Science, System Administration or a closely related field, or equivalent experience required.
- 1-3 years of related experience in the GxP environment.
- Some Knowledge of 21 CFR Part 11 compliance and GAMP 5
- Previous administrative experience with Salesforce or Veeva.
- Have worked on Computer System Implementation projects in the past and have written SOPs/WIs for these projects or related systems.
- Understanding of how to write basic SQL Statements and Excel Formulas.
- Simple coding knowledge (HTTP, Javascript or Python) as well as how an API is developed and used by the system is considered a plus.
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 and annual restricted stock unit and stock option awards 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.