Analytical Product Owner (APO) for Gene Therapy (m/f)


  • Company:
    Shire
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    7 days ago
  • Category:
    General

Takeda is the leading biotech company in rare diseases and sees a significant need for rare disease innovation. One example is Takeda’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 Takeda 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!

**_Notice to Employment / Recruitment Agents:_**

_Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration._

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.