companies from start-up to TOP20 pharma. We provide unique expertise and services to pharmaceutical companies to successfully develop their biopharmaceutical drug candidates from early stage to approval and beyond.
Biopharmaceutical cmc specialist (m/f)
Preferentially you have several years of experience in technical development and involvement into successful
licensure for biopharmaceuticals.
development related questions, specific questions on assays and assay development, stability, cell substrate
characterisation, virus safety related questions. Apart of your unique scientific know-how in CMC we expect
understanding of regulatory principles and proven communication skills in the dialogue with internal and external stakeholders and excellent technical writing skills.
- Experience in CMC activities /technical development of biopharmaceuticals
- Contribution to regulatory dossier preparations (quality part) such as IMPD, IND or MAA, BLA
- Experience in specific areas of development of biopharmaceuticals such as development genetics,
development of analytical methods, virus safety, tech transfer, formulation or others
- Solid understanding of structural-functional relationship and of the special features of these products
- Ability to establish strategies for novel development concepts and to assess proposed strategies on CMC
- Demonstrated ability to coordinate and interface effectively within cross-functional groups
- Excellent team-player
- Very good organizational, communication and writing skills
- Fluent English language, German language skills a plus
- A spectrum of highly interesting projects which are all unique and at the forefront of the
current state-of-the art of science and development of novel biopharmaceuticals
- Work with a team of internationally renowned experts in their field
- Regular exposure to external stakeholders such as clients and agencies in all parts of the world
- Challenging responsibilities and room for creativity
- Cross-cultural working environment
- A detailed curriculum vitae
- Motivation letter
- List of publications if applicable
- Description of past experience and future interests
- Name and addresses of three referees
firstname.lastname@example.org. Please specify your salary expectations.
Biopharma Excellence GbR
c/o Munich Technology Center
80992 Munich, Germany
Phone : +49 (0)89 55050890