Environmental Technical Lead recognized expert in contaminated sites assessment with over 12 years environmental consulting experience. Leading complex projects and mentoring talent at Arcadis.
About the role
- Product Technical Lead providing company-wide technical leadership of (bio)pharmaceutical products through their lifecycle. Collaborating with various teams to ensure product quality and regulatory compliance.
Responsibilities
- Be the company-wide technical lead for assigned (bio)pharmaceutical product(s) of the portfolio encompassing a variety of modalities, primarily drug substance, raw materials through drug product packaging and associated testing of manufactured products
- Maintain knowledge and history of the product(s) process throughout the entire commercial lifecycle, inclusive of development history
- Perform process management in the following areas (but not limited to): Owner of product improvement road map, Owner of specification review committees, Owner of product technical risk summary (based on product risk register) in conjunction with product quality risk register
- Perform process capability analysis (periodic basis) and provide recommendations, in support of APQRs and product reviews
- Review CPV plans and outputs reports for recommendations
- Serve as an empowered Alexion Technical Operations representative working collaboratively and cross-functionally...
Requirements
- Degree in scientific or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering: Minimum Batchelors Degree
- Demonstrated previous experience in a CMC lead / product technical lead role with demonstrated ability to lead cross functional team in a matrix environment
- Demonstrated ability to build new organisations or business processes
- Extensive technical knowledge of pharmaceutical manufacturing, in Technical, R&D, Process Development, or similar Product Stewardship/Champion roles.
- Experience in a combination of areas such as DS/DP processes, combination devices, final packaging, vaccine manufacture, cell and gene therapy, oligonucleotides, and associated relevant background in analytical testing/characterisation
- Extensive technical knowledge of commercial manufacturing with experience with biologics or small molecule, or development manufacture
- Comprehensive understanding of cGMP requirements and the ability to implement best practices to ensure technical excellence
- Expertise in successful execution and management of technology transfer, process support within a clinical/commercial facility, or product development setting
- Excellent communication skills with the ability to successfully influence across levels, across functions, with senior leaders and technical leaders
- Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities
- Strong technical writing skills and statistical analysis experience
- Ability to travel up to 15%
Benefits
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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