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Biotechnologist, Biologist, Biochemist, Pharmacist as Biopharmaceutical CMC Specialist (m/f)

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Biopharma Excellence is a biopharmaceutical consulting company that supports locally and globally acting
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.
We expand our team and look for unique biopharmaceutical experts for our office in Munich.
Specifically we are looking for

Biopharmaceutical cmc specialist (m/f)

We need you if you have solid experience from practical involvement into various CMC development projects.
Preferentially you have several years of experience in technical development and involvement into successful
licensure for biopharmaceuticals.
You will be in charge of all projects which require CMC know-how, such as manufacturing process and process
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.
Your Profile:
  • 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
    related questions
  • 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
To fill this position successfully you have a PhD in natural sciences like Biotechnology, Biology, Biochemistry, Pharmacy, and minimum of five to eight years in in the pharma or biotech environment.
We offer:
  • 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
Applications (in English) should contain the following documents:
  • A detailed curriculum vitae
  • Motivation letter
  • List of publications if applicable
  • Description of past experience and future interests
  • Name and addresses of three referees
We look forward to receive your electronic application with reference to “CMC” via Please specify your salary expectations.
Contact: Mrs Sabine Kistner
Biopharma Excellence GbR
c/o Munich Technology Center
Agnes-Pockels-Bogen 1
80992 Munich, Germany
Phone : +49 (0)89 55050890
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