Sr. Scientist

ImmunoGen, Inc. Waltham, MA
Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology. ImmunoGen's lead product candidate, mirvetuximab soravtansine, is being advanced to a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about ImmunoGen can be found at www.immunogen.com.

The Opportunity:

Under the direction of the Senior Director, Chemical Process Development (ChPD), ensure successful development, technology transfer and execution of ImmunoGen's small molecule manufacturing processes as part of our Antibody Drug Conjugate platform. This role encompasses responsibilities in internal process development, technology transfer to external CMOs and oversight during development phase, regulatory documentation support and CMC team representation. Focus of this position will be on technical and CMC strategic aspects pertaining to internal and external activities and supporting the establishment of late stage development capabilities.

* Conduct and oversee laboratory work to define and characterize chemical routes and processes to produce phase appropriate material leading eventually to process validation

* Design and carry out PAR studies, crystallization studies, etc.

* Partner with External Manufacturing and Manufacturing Sciences teams as a subject matter expert for outsourced projects. Specific activities include:

* Conduct scientific oversight of CMO activities

* Manages project timelines and budget

* Vet potential CMOs for technical ability in small molecule manufacture

* Co-author RFPs for manufacture of payload and linkers

* Travel to CMO sites for technical inspection

* Prepare, sign and archive all relevant characterization/manufacturing documentation that pertain to assigned projects (such as PAR reports and characterization reports, including impurity fait mapping)

* Serve as ChPD representative on project CMC teams and ensure all stake holders are informed

* Author IND and BLA (e.g., small molecules sections)

* Interface with regulatory department and define clear expectation of final work product

* Serve as ChPD subject matter expert on IMGN partner teams

* Ensure information flow and excellent interface connectivity

* Ability to travel, as required (10–15%).

Who You Are:

* PhD in organic chemistry or chemical engineering background in the pharmaceutical sciences plus at least 8 years of experience in the biopharmaceutical industry to include GMP manufacturing experience.

* Process Chemistry development skills from bench to CMO

* Proven track record of process characterization, technical transfer and support of manufacture under the GMP setting

* Understanding of DoE is preferred or highly recommended

* Experience in working in a matrix team setting

* Strong customer orientation and excellent communication skills are required

* Ability to set or determine clear expectations between interfaces

* Work in a collaborative manner, understanding the end goal

Personal Characteristics:

* Results Oriented: Consistently delivers. Has flexible and creative problem solving skills.

* Strategic Thinker: Is able to see the big picture and understand the interrelationships of complex manufacturing processes.

* Approach to Problem Solving: Thinks logically, develops and evaluates options, and identifies pros and cons.

* Communications: Strong, clear communicator. Able to communicate across functions and bring people together around a common goal.

* 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.

* Innovation: Drives and supports new ways of thinking and embraces change.

* Patient Focus: Work with urgency, and go the extra mile. The patient is waiting.

Physical Requirements:

* 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.

* Must be able to lift and carry up to 10 lbs

* Must be able to talk, listen and speak clearly on telephone

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

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. 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.

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