Job Title: CMC Operational Planning & Capacity Manager
About the Job:As part of the CMC Operational Planning & Capacity team, the primary role of the CMC OPCM is to customize, plan and track the CMC activities in Research & Development (R&D) and in Manufacture & Supply (M&S) with their timelines and resources reflecting the operational reality and aligned with the overall global project strategy. R&D scope is from Research to Preclinical and Clinical Development, and Product Life Cycle Management post initial market approval.
Main Responsibilities:- For each assigned therapeutic project (biologic molecule) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the entered plan and regularly updated in the planning tool (Planisware solution). The CMC OPCM ensures that the CMC strategy is accurately reflected in terms of project logic with the timelines, including the CMC High Level Plan, and resource workload,
- In addition, the CMC OPCM provides workload and capacity analyses and reporting to support the CMC Project Team, and Managers in the CMC Functions if assigned as Function Business Partner. In particular, he/she develops scenarios to make recommendations on optimization of timelines and of resources, and to support decisions for site re-allocation or outsourcing if there is any bottleneck,
- The CMC OPCM also analyses the project deliverable timelines and critical path activities e.g., in support of CMC risk management assessment by the CMC Project Team,
- The CMC OPCM is also responsible for ensuring alignment of his/her CMC activities with global strategic project planning and other operational planning from Translational Medicine, Clinical Sciences and Regulatory Affairs, while ensuring proper connectivity and integration of these cross-functional dependencies within the planning tool.
- Evolving in an international environment, the CMC OPCM regularly attends CMC Project Team meetings, planning meetings and other related meetings linked to project timelines and resources management (e.g., R&D governance preparation, CMC Function review) and to OPCM business management.
Key Internal Relationships:
- CMC Project Team members covering the whole CMC development in R&D and M&S including Clinical and Commercial Supplies, Regulatory and Quality,
- Global Project Planning Managers embracing the project strategic planning,
- OPCMs working on other operational activities like preclinical, clinical development and regulatory,
- CMC Functions Managers on local sites and Finance Business Partners,
- The whole community of CMC OPCMs working on all types of molecule modalities located in Frankfurt & Berlin-Germany, Paris & Montpellier-France, Boston area-USA and Budapest-Hungary.
About You:Basic Qualifications
Education- Bachelor's degree, Master's degree, PhD, or MBA in a scientific, technical, or business-related field (e.g., Pharmacy, Engineering - including Chemical, Electrical, or Mechanical -, Biology, Chemistry, Business Administration, or equivalent).
Experience- 5+ years (Bachelor's), 3+ years (Master's or MBA) OR 2+ years (PhD) of experience in project planning and management and/or CMC operational/laboratory activities within the pharmaceutical, biotechnology, or related regulated industry
- Relevant academic/research experience (e.g., co-op, internship, or postdoctoral research in biology or pharmacy-related fields) may count toward the total years of experience when combined with industry experience.
Preferred Qualifications
- Proactive adoption of Digital and/or AI solutions in a work environment
- Experience in Biologics and/or Gene Medicine CMC operations
- Familiarity with AAV (adeno-associated virus) or LNP (lipid nanoparticle) platforms
- Knowledge of planning and project management tools (e.g., Planisware or equivalent)
- PMP or CAPM certification
- Experience with data visualization tools such as Tableau or Power BI, or advanced Excel skills
- Knowledge of finance and budget management
The salary range for this position is:
$122.250,00 - $176.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
