Job Description
Your Key Responsibilities:
Stewardship
Your responsibilities include, but not limited to:
- Ensure all results related to product stewardship are available including those related to Quality Modules and SOPs, in close collaboration with project team.
Validation
- Ensure all results related to validation are available including those related to Quality Modules and SOPs, in close collaboration with project team.
Launch & Transfer
- Provides an overview of all ongoing and planned technical transfer activities to all relevant partners
- Leads all aspects of all timeline scenarios including risks and options
- Supports Bio transfer team with vast expertise in DS development and production (USP and DSP) as well as hands on expert knowledge for technical transfer and submission activities
- Align reporting closely with Bio transfer team as well as all relevant partners
Manufacturing Excellence For Launch And/or Transfer Assigned
- Chip in to the life cycle management of the product.
Training
- Be responsible for the Training Curriculum, job profile.
Essential Requirements
What you'll bring to the role:
Education (minimum/desirable)
BSc or equivalent experience. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience.
Languages
Fluent in English and proficient in local language of respective country. Relevant
Experiences
- Proven demonstrated ability of 15+ years in drug substance pharmaceutical development and manufacturing of drug substance biologics (large molecules); comprehensive know how in pharmaceutical technology, project management experience.
- Experience in a global/matrix environment in the pharmaceutical industry.
- Thorough understanding of drug substance biological production processes incl transfers and submissions.
- Comprehensive know how in drug substance biotechnological production processes.
- Strong project management skills.
- Strong communication skills.
You'll Receive
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz