As scientific lead (m/f/d) in LNP and non-viral vectors you define, realize and guide the scientific path to success in the evolving field of nonviral
gene vectors and other new intracellular drug targeting approaches in formulation development. Be at the front end of science worldwide
on how LNPs and non viral vectors can be further developed to the degree of tropism and transfection efficiency of AAVs and other viral vectors. 
 

YOUR TASKS AND RESPONSIBILITIES

• Scientifically guide all stages of the CMC development chain from vehicle lead optimization to product launch with focus on
  nonGxP to GMP transfer, scale-up and comparability incl. CQA and CPP 

• Drive technology development and continuous improvement initiatives that anticipate emerging needs in formulations,
  fill-finish processes, or drug delivery of parenteral drug targeting 

• Act as a scientific advisor (m/f/d) for strategic direction and investment opportunities in the field and as a mentor (m/f/d) for the development of talents

• Further co-evolve regulatory CMC environment with internal and external regulators with focus on understanding CQAs and
  CPP and comparability exercises

• Co-build and maintain scientific and technical expert communities across R&D for biopharmaceutics

• Lead externally through scientific conferences, publications, and/or consortia engagement and capture innovations in patents and publications
  and present to the scientific community

• Guide and support BD&L processes in the field of parenteral drug targeting to technical evaluation and CMC risk assessment

• Track competitor activities and major IP generation and ensure that CPD project work in your area is captured into our own IP

WHO YOU ARE

• Ph.D. in a Life Sciences related field with long-term industry experience in the field of Drug Delivery Innovation

• Proven experience and track record in the development of parenteral drug carrier constructs and targeting approaches in the pharmaceutical
  industry with focus on lipid based carriers and gene delivery

• In-depth knowledge of aseptic DP manufacturing of sterile drug product both in liquid and lyophilized forms is highly desired

• Deep understanding of FDA/ICH/EMA guidelines and cGMPs, phase-appropriate development strategies and global requirements
  for IND, NDA and BLA sub

• In-depth familiarity with the external community of CROs and CMOs and authorities when it comes to transit from early POCs to successful late
  stage CMC development and technical commercialization 

• Ability to lead with purpose, develop strategies and mobilize employees to deliver exceptional value and outcome as well as credibly
  embody and rolemodel the LIFE 2.0 values

• Ability to build high-performing teams as well as embrace change and seek new opportunities to leverage digital solutions, continuously
  striving to reduce complexity and introduce a continuous learning mindset

• Fluency in English is mandatory; command of a second major European language, especially German, is an asset

This position can be based in Wuppertal, Turku or Berlin.