Head of Chemical Manufacturing Control (Head of CMC)
|Department:||Preclinical Development, Development Projects|
|Responsible To:||Chief for Preclinical Development|
|Location:||Prague, Czech Republic|
|Employment Type:||Full Time Employment|
We are seeking a Head of CMC who will be responsible for leading all process development and manufacturing aspects of SOTIO’s development projects. The successful candidates should have leadership and management experience including early development at research lab scale as well as with transferring processes to CMOs and manufacturing for clinical studies at CMOs. The candidate will be responsible for managing and coordinating development and manufacturing of exciting new drug candidates developed at Sotio, including monoclonal antibodies, recombinant proteins and small molecules.
Key Activities and Responsibilities:
- Lead the generation of biologics drug candidates from cDNA to small batches of purified protein. Build and lead these activities in-house with responsibility for a CMC team.
- Develop the experience within the CMC team to accommodate current and future needs according to the development candidates and activities. Ensure that the required initial and continuing training of the CMC team is carried out and adapted according to need.
- Represent the sponsor for all activities at CMOs. Lead and guide the activities aiming at development of processes and manufacture for clinical studies. These activities include cell line generation, process development (up-stream, down-stream), manufacture, testing and release.
- Coordinate and obtain proposals from CMOs, provide input to contracts and manufacturing agreements with CMOs. Ensure that timelines, costs, and quality objectives of the activities are met.
- Identify and troubleshoot manufacturing process and bottlenecks and provide continuous recommendations for improvements in the manufacturing area, optimize bioreactor processes and conditions to improve product yield, quality, purity and cost of goods
- Provide expertise to the development team to ensure proper timeline planning and budgeting.
- Interact with external CMC experts as needed to obtain further input on development strategies, process optimization and quality aspects. Interact with Quality Assurance and Quality Control Departments.
- Ensure and manage the writing of a proper CMC documentation, review development and production reports.
Competences, Skills and Qualification:
- PhD degree in Biotechnology, Cell Biology, Biochemistry or related field.
- At least 8 years-experience in biopharmaceutical manufacturing with a minimum of 3 years in a management role, engaged in the production of biotechnology products.
- Extensive know-how and experience in process development and GMP manufacturing of biological products including monoclonal antibodies and recombinant proteins.
- Experience and know-how with small molecules is seen as a strong asset, allowing the management of development and manufacturing activities with small molecules at CMOs.
- Knowledge and successful implementation of quality requirements in the manufacture and release of biologics and ideally small molecules for use in clinical studies.
- Experience in the transition of development candidates from the preclinical stage to clinical testing. Ability to generate the CMC development strategy for a development candidate from early clinical testing up to commercial production.
- Proven ability to manage activities at CMOs and to identify and troubleshoot issues with equipment, manufacturing processes and timelines.
- Excellent team management and communication skills. Used to work in interdisciplinary development teams.
- Excellent interpersonal skills and the ability to communicate well orally and in writing in English are required.
- The position will be based in Prague, Czech Republic.
Contact us (firstname.lastname@example.org)
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