Senior Manager CMC (f/m/d)

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