Overview

Tasks and responsibilities
As Director Analytical Development (m/f/d) you will be responsible for different teams and laboratory units reporting to the Quality Control department. You will lead and support analytical activities and strategies related to method development, -validation and comparability assessments for multiple early- and late-stage programs for our customers.
Lead and mentor internal and external teams throughout the analytical lifecycle (method development and validation) of drug substance, drug product and intermediates
Define and oversee science-driven, phase-appropriate analytical development and validation strategies and related business processes for internal and external labs that are consistent with cGMP and international guidelines
Work with multidisciplinary teams and collaborate with other areas in process development, manufacturing, as well as external parties
Deliver analytical solutions that enable process -, product – and analytical control strategy development
Support the definition of critical quality attributes and establish robust analytical control strategies that can be transferred into Quality Control and successfully registered globally
Develop and manage method development and validation metrics for performance improvement of the team
Represent Analytical Development and Quality Control to internal and external customers
Provide leadership to aid in analytical investigations and assay trouble shooting
Review and approve analytical documents including but not limited to protocols, reports and procedures
Review analytical sections in regulatory submission documents (e.g. IND, IMPD, MAA, BLA)
Identify and monitor disruptive analytical technologies and regulatory trends

What is important to us
Scientific degree in life sciences with a focus on analytical techniques for proteins and more than 5 years of experience in analytical development in the biopharmaceutical industry
Strong leadership skills and experience with the leadership of large organizational units
You are a team player and enjoy working in multidisciplinary teams irrespective from hierarchic levels
Strong background in method development, validation and regulatory guidelines for protein drug substances (CE, HPLC, ELISA, Bioassay)
Sound understanding of protein chemistry and associated CQAs
Experience in the management of organizations working on a variety of products is a plus

We offer
Work in a company that offers real value and manufactures medicines for critically ill patients
Contagious joy in the job as well as a collegial working environment
Access to exclusive, personalised training through the Global Rentschler Academy
30 days of holiday
Flexible working hours and option to partial mobile working
Responsibility, initiative, further development
Company health management and pension scheme
Company child-care centre
Future-proof industry

WWW.RENTSCHLER-BIOPHARMA.COM

Rentschler Biopharma SE

Erwin-Rentschler-Str. 21 · 88471 Laupheim · www.rentschler-biopharma.com