Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Operations Team in Heidelberg, Germany, we are looking for a full-time

Senior Manager CMC (f/m/d)

Reference No. OP2216

You will be involved in front-line and challenging research and development projects on novel technologies in the fields of therapeutic antibodies and cell therapy that enables the development and characterization of our product candidates.

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Responsibilities

  • Facilitate the CMC project-planning process, drive execution of CMC development plans and CDMO manufacturing and monitor progress
  • Coordinate and monitor product development (therapeutic protein and/or NK cell therapy encompassing cell line, USP, DSP, formulation and analytical development, packaging and labeling, clinical supply) for cell therapies and compounds from Affimed’s proprietary ROCK® platform through the entire development cycle from enabling IND, clinical supply up to regulatory filing
  • Plan, coordinate and manage phase-appropriate cGMP-compliant manufacturing activities at CDMOs starting from IND-enabling production to late-stage clinical supply and validation
  • Support and enhance the clinical supply chain function by ensuring timely availability of clinical trial material in close coordination with quality and clinical operations
  • Manage the identification and selection of adequate service providers for development, manufacturing, and supply activities
  • Drive identification, evaluation, and implementation of new technologies for manufacturing, formulation, protein analysis and supply
  • Lead the preparation of CMC project budgets, facilitate appropriate review, and maintain forecasts
  • Regularly interact with functional areas beyond CMC and Clinical Supply Chain, such as Research, Non-Clinical Development, Regulatory, Quality and Clinical; member of a cross-functional project team
  • Ensuring delivery of high-quality data, presentations and reports including required documentation for regulatory filings (IND/BLAs)

Requirements

  • Graduate degree (e.g. Ph.D., master, diploma) in chemistry, biochemistry or related life sciences with at least 3 years of CMC management experience, including later-stage (phase III) projects
  • Knowledge of guidelines/monographs related to CMC (more specifically biologics/parenteral products)
  • Understanding of other functions (e.g. what´s required in terms of non-clinical studies for an initial IND filing, how is a clinical trial generally conducted)
  • Need to understand both the technical specificities of CMC (e.g. process, data interpretation) and the larger picture (company strategy, business objectives, other functions)
  • Strong technical expertise in analysis, development and manufacturing of biologicals including technology transfers
  • Experience in clinical supply management
  • Experience working with supply chain technologies (i.e. IRT, CTMS, IWRS integration rules and principles)
  • Strong team collaboration skills as well as ability to work independently
  • Ability to lead through example and to establish an environment fostering effective and collaborative working relationships in multi-disciplinary teams
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively towards solutions in a challenging, milestone-driven environment
  • Proficient in managing budget, timeline, and alignment
  • Execution-driven mindset
  • Profound communication skills in English and German, both written and oral

We Offer

  • Multifaceted and responsible position, working on innovative projects in an international environment with strong team spirit
  • Space for commitment and personal initiative with the possibility for personal and professional growth
  • Attractive, performance-related compensation package and further benefits:
    • Employee financial participation in form of stock options
    • Attractive pension allowance from employer
    • Low-cost use of local public transportation (Jobticket)
    • Free parking spaces
    • Bike Leasing
  • Flexible working time, possibility to partially work remotely (depending on function)
  • Regular company events such as Culture Day, Summer Get-Together, participation in charity events

For any queries, please contact Susanne Hering (Tel: +49 6221 6743 675, e-mail: s.hering@affimed.com).

We are looking forward to receive your application (incl. motivation letter and salary expectations).

October 2022

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