HEAD of EXTERNAL MANUFACTURING

Location
02451, Waltham
Posted
Mar 16, 2018
Ref
(#5821)
Required Education
Bachelors Degree
Position Type
Full time

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 VP, Technical Operations, ensure successful execution of the ImmunoGen manufacturing strategy and plans.  This encompasses all elements of Antibody Drug Conjugates (antibody, payload, linker, drug substance and drug product, including manufacturing and testing) and spans activities from early development through product commercialization.  Given the external nature of the manufacturing network, ensure partnerships are established and maintained with suppliers that meet ImmunoGen’s strategic goals, balance cost and risk, all without compromise to quality or compliance. 

  • Provide strategic vision, leadership and direction to the External Manufacturing organization to deliver against ImmunoGen’s operational and long-term objectives.
  • Establish criteria for potential suppliers, coordinate assessments and RFPs and make recommendations for inclusion into the ImmunoGen external manufacturing network.
  • Identify and recommend partnership/contract terms that provide the appropriate balance of flexibility and cost to align with the strategic assessment of program risk.
  • Oversee contract negotiations and engage with supplier senior leadership as required to ensure that ImmunoGen’s strategic interests are being satisfactorily addressed.
  • Oversee and guide Supplier Relationship Teams and Technical Product Stewards towards the successful installation of new assets into selected suppliers (i.e., timely and efficient technology transfer of processes and methods).Provide person-in-plant and/or technical support as needed during technology transfer as well as routine manufacturing.
  • Oversee and guide Relationship Managers in communicating demand, scheduling of production and testing, and balancing tradeoffs to ensure necessary inventory levels are maintained and supply is uninterrupted.
  • Oversee and guide Relationship Managers in monitoring supplier compliance to contract terms.
  • Participate in Business Review sessions with suppliers to reinforce expectations for performance, convey strategic interests and demonstrate commitment to cooperation in an effort to maximize value across the relationship (e.g., sharing of goals and priorities, joint improvement efforts, etc.).
  • Perform periodic risk assessments of supplier network, communicate findings to senior leadership and initiate actions as necessary to maintain a satisfactory risk profile. Collaborate with Quality Product Stewards to ensure manufacturing and testing is conducted in compliance with all applicable filings, regulations and cGMPs.
  • Establish functional priorities and goals and identify performance improvement targets and metrics ensuring capabilities are in place to effectively deliver on all commitments and performance targets.
  • Prepare annual and multi-year financial budgets and forecasts. Manage headcount and expenses to meet approved spending plans while delivering on commitments.
  • Ability to travel, as required, to support partner execution.

Who You Are

BS, MS or PhD in relevant science or engineering discipline.

  • At least 15 years of experience in the biopharmaceutical industry to include leadership of an external manufacturing organization and associated activities overseeing a diverse set of suppliers providing GMP services.
  • Solid record of accomplishment in building alliance relationships with external manufacturing partners and building and managing an external manufacturing network.
  • Experience in successfully negotiating competitive supplier contracts.
  • Experience in effectively managing cross-functional teams in a matrix organization.
  • Experience in both small molecules and biologics, as well as involvement in process development of ADCs is preferred.
  • Strong knowledge of global regulatory environment. Experience with supporting regulatory filings, such as facility validation and compliance related aspects, is a plus.
  • 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. 
  • Team Leader: Able to manage and lead a group of diverse individuals and assess and nurture talent.  Encourages team to present and debate their best ideas and holds the team accountable for results   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. 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.  Drives and supports new ways of thinking and embraces change.
  • Patient Focus:  Work with urgency, and go the extra mile.  The patient is waiting.

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.