At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Scientific Lead LNP and non-viral Vectors (m/f/d)
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.
This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Location: Wuppertal, Turku or Berlin
Reference Code: 559375