Shire is the leading biotech company in rare diseases and sees a significant need for rare disease innovation. One example is Shire’s gene therapy hub in Orth an der Donau. In the past years the company has established a solid gene therapy platform based on adeno-associated viruses, which comprises vector optimization, analytical assays, scale-up expertise and a GMP-compliant production process. The experience gained in the process is also offered to external partners. The APO is accountable for the technical continuum of analytical methods and strategies from early stage to end of commercial life cycle of a product. As an expert in analytical development of biologics the APO identifies, strategizes, prioritizes and manages analytical development activities to bring agile resolution to a variety of problems.
About the position:
- Accountable/responsible for the Analytical Development Plan and analytical control strategy
- Responsible for analytical input to the Pharmaceutical Development Plan
- Contributes to/prepares regulatory sections (eCTD sections) and related agency written information
- Accountable for analytical method transfer
- Accountable for strategy of product specific reference material
- Accountable/responsible for the justification of specifications
- Owns the preclinical specifications and provide inputs to Phase 1/2 specifications
- Owns sampling plans for extra sampling, provide inputs to the routine sampling plans
- Responsible for input to analytical product comparability and physiochemical/biological characterization
- Interface to Quality Control
- Responsible for interface to R&D for late research programs, expertise exchange between Discovery Therapeutics and Process Development for analytical assays (e.g. Asset Nomination input)
- Represents GT from analytical perspective in authority meetings, external collaborations, conferences
- Provides input for publishing and participation strategy for GT analytical methods
- Actively participates in Due Diligence and Technical Assessments
- Contributes from scientific perspective to the progression of GT analytical methods
Skills you need:
- Postgraduate degree in the biological or chemical field, ideally an education with a specialization in biotechnology or biochemistry
- Experience in process industrialization of gene therapy process (e.g.cell biology, fermentation, protein purification) and biotechnology would be ideal
- Several years of experience within the biotechnological- or pharmaceutical industry
- Ability to identify and resolve complex technical issues
- Enthusiastic, decisive and motivating personality
- Excellent verbal and written communication skills in English and German
- Experienced in setting up, designing and monitoring implementation of research projects
- Experienced in establishing new methods in the lab and planning of experiments
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success.
The minimum salary for this position is € 4.225,44 gross per month (full-time); increased payment is possible. We are looking forward to your application!