CMC Manager / Lead
We are looking for a CMC Lead / Manager within the CMC organization with the focus on biological drugs development. The CMC activities are based on science and innovation, a regulatory body of guidances and compendial monographs and industry benchmarks. Within the Sotio organization the majority of CMC activities will be executed with external partners (CDMOs, CMOs, CROs).
The CMC organization is accountable for establishing the physicochemical properties of a new chemical or biological entity including structure function studies in support of drug potency, stability and safety; the CMC accountability includes:
- Integrated planning for CMC work-packages and sub-projects including resources, timelines, budget.
- Selection of external partners, contracting,
- Establishing the basic scope of work and design of the CMC activity,
- Establishing and reviewing detailed executional development, manufacturing or other study plans,
- Monitoring of the executional phase and provide guidance for high–level process design, technology and innovation.
Every project require a risk mitigation plan, planning for acceleration scenarios and should be accompanied by a manufacturability assessment freedom to operate assessments.The CMC organization is further responsible to:
- Develop a manufacturing process and control strategy to support the clinical supply of the new medicinal product including scale up for large scale clinical and commercial production according to ICH GMP guidelines.
- Develop a drug product formulation and drug product dosage form in support of the clinical phases and commercial launch including the establishment of stability and solubility data.
- Support regulatory filings by authoring the respective CMC chapter of the submission documents.
This position requires strong communication skills within the various functions of Sotio related to CMC activities but also with all the CDMO and CRO partner organizations.
Key Activities and Responsibilities
- Contribute to the products target development profile, quality target product profile, pharmaceutical development plan, manufacturability and developability assessment.
- Establish and contribute to developmental work plan in terms of process and product designs, production technologies and analytical technologies and innovation.
- Approach CRO or CMP partners to build relationship, get quotes and contracts, align on legal terms, and finalize the detailed work plan. Examples of typical projects: cell line development; drug substance process development or optimization; drug product formulation development; Analytical method development; GLP and GMP drug product and drug substance manufacturing; analytical comparability studies; viral safety studies; drug product and drug substance stability studies; technology feasibility studies; impurity characterization study; process parameter range studies (DOE).
- Monitor the executional phase of a developmental work package and provide scientific guidance in terms of technology design, innovation, industry standards and trends.
- Project management to set up communication, meeting, proper documentation data management and summarizing of work progress in slide decks (dash board formats). CMC related documentation includes meeting minutes, study plans, study reports, batch records, certificates of analysis, summary slide decks, dash board, scientific papers, patents, quotes, contracts, SOWs and others more. The data management includes storage, distribution and accessibility of the data for internal and external partners.
- Actively drive technology and development benchmarking with industry (conferences, Biophorum, literature, patents).
- Represent CMC within the Sotio organization.
- Support the non-clinical development organization in design and developability. assessment of pipeline candidates.
- Support the business development organization in evaluation new molecules and programs (Due Diligence).
- Contribute to submission documents (authoring, reviewer).
Competences, Skills and Qualification
As a CMC lead you should have:
- Education in the life science area, preferentially Biotech with a PhD or Master degree
- Excellent language skills in written and oral English
- Experience in the area of biologicals process development including cell line, upstream, downstream and formulation development
- Experience in the process scale up and knowledge on requirements derived from GMP guidance
- solid knowledge of analytical tools related to biological drug products
- Solid knowledge of Quality by Design concepts for product and process development
- Charismatic and authentic personality to motivate and drive teams and projects and position CMC as credible partner to internal and external partners
- Structured thinking and excellent time management
- Solid skills in use of software (MS office, MS project, communication software, installation of sharepoints, regulatory submission software,…)
- Team player and pragmatic thinking