The process implementation expert will interact closely with drug substance process development teams, the quality team, and manufacturing network to ensure seamless process/knowledge transfer and manufacturing support at all development stages.
Job in detail:
- Providing process and product expertise to development GT programs in various stages
- Tech transfer of the process for different GT programs from Early Stage Development to Late Stage Development and GMP manufacturing
- Accountable for developing/optimizing process transfer protocols (Fit for purpose); Define the deliverables of the transferring unit
- Providing technical support including on the floor support during GMP production of Gene Therapy products
- Contributing actively to risk assessments, deviations, GMP investigations and assessments of change controls
- Providing support in raw material selection for media and buffers
- Responsible for providing expertise in raw material selection for media and buffers for GT programs; technical review of manufacturing documents
- Support of submissions and responses to authorities
Skills you need:
- 3+ years of experience in biopharmaceutical industry
- A strong background in cell culture-, upstream-and/or downstream techniques
- Background in QbD development and manufacturing principles
- Strong quality, regulatory and cGMP knowledge
- Excellent interpersonal, problem solving, and communication skills are required as well as ability to work in a matrix
Strong written and verbal communication skills (German and English)
Strong presentation and negotiation skills
Very good analytical thinking, Six Sigma Green Belt Certification or equivalent desirable
Project Management experience is a plus
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.
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 € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application!
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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.