Job title: CMC PROJECT MANAGER (F/M/D)
Company: Myelo Therapeutics GmbH
Job description: Myelo Therapeutics GmbH develops innovative treatments in areas of high unmet medical needs. Our clinical-stage lead compound prevents Chemotherapy- and Radiation-induced Myelosuppression, a common and serious side effect of anticancer therapy. In addition, Myelo Therapeutics develops a therapy for Acute Radiation Syndrome in close collaboration with the US National Institutes of Health. Myelo Therapeutics won several entrepreneurship and innovation awards and was selected as one of the “Top High Tech Ventures of the East”. Our international team works in a bright, spacious loft office in the heart of Berlin-Mitte.
Myelo Therapeutics offers an attractive position in a challenging work environment and a lean, non-hierarchical organization. We give our employees a large degree of freedom to drive our scientific, manufacturing, and commercial progress and to grow professionally.
The position will report directly to the Head of Non-clinical Development and CMC. In this role, you will manage and provide operational support to drug development projects with an emphasis on Chemistry Manufacturing and Controls (CMC) and CMC regulatory documentation. You will play a key role in developing treatments for some of the most relevant medical challenges of our time.
- Develop, update, and optimize CMC project plans, facilitate communication internally and with external partners
- Develop projects timelines and study conduct plans, manage, and coordinate effectively and efficiently assigned activities from start-up to completion
- Prepare project presentations and reports describing accurate and current details.
- Proactively identify potential risks to CMC timelines and deliverables
- Manage and coordinate with external parties performing outsourced CMC activities including but not limited to Contract Development and Manufacturing Organizations (CDMOs), Contract Testing Laboratories, and Subject Matter Experts
- Manage expert consultants in the areas of CMC analytical method development/qualification/validation and stability data trending/evaluation as required
- Support CMC quality control investigations at CDMOs including implementation of applicable Corrective and Preventative Actions
- Support development of CMC-specific SOPs and standards, including CMC vendor oversight plans
- Information management for small molecule development program
- Review of incoming CDMO documents, such as technical reports, batch records, protocols, change controls, and other documents related to drug development and clinical trial supply
- Preparation, management, review, and archiving of internal CMC databases
- Contribute to the writing, compiling, review of CMC sections of regulatory documents, including but not limited to Investigational New Drug (IND) applications and Clinical Trial Applications (CTA)
- Survey FDA, EMA, ICH regulatory CMC guidance databases periodically to stay abreast of current regulatory guidelines
- Advanced Degree (MSc, Ph.D.) in Chemistry, Biochemistry, or related disciplines
- Critical evaluation of analytical data, knowledge of fundamental principles of organic chemistry and/or pharmaceutical sciences
- Minimum of 2 years hands-on experience in multiple aspects of the manufacturing process and quality control for pharmaceuticals with exposure to different scientific/technical CMC development areas (process development, analytical development, manufacturing, stability)
- Understanding of GxP as well as FDA, EMA regulations, and guidelines related to CMC
- In-depth knowledge of the pharmaceutical industry and drug development and approval process a plus
- Technical writing skills with CMC regulatory dossier experience considered a plus
- Openness and interest to learn about and contribute to new areas related to pharmaceutical research and project management
- Excellent verbal and written communication skills in English and German
- Scientific judgment and interpersonal skills
- Proficiency in MS Office Suite
We offer a dynamic and ambitious start-up environment with broad opportunities to learn and grow. Incentives include a flexible home office / remote work policy, and perks such as gym, or public transport co-pay. The position advertised is a permanent position 50% or full-time. Starting date: April to June of 2021.
If necessary, we may support you in obtaining a German work permit.
Please send your CV along with your expected salary and earliest date of availability in an Email.
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