Technology Transfer (TT) Senior Specialist, Italy

Milano  /  Quality, Compliance, & Regulatory  /  Full Time


CAI Italy, is seeking a Technology Transfer senior, The work position is hibride: remote working and client site. The location in Milan it's just an example.
ESSENTIAL DUTIES AND RESPONSIBILIITES 
To ensure TT projects related tasks are executed on time and on a technical correct basis. To ensure that CAI processes and projects are executed according to the CAI directives and procedures. in place in the country/region. To ensure appropriate contacts and communication with project manager/s and CAI involved management. To review/challenge and propose
( when requested by the project/customer) technical approaches related to TT activities in terms of process industrialization, scale up, Process Validation, supplier and materials qualification requirements, Analytical method transfer and validation approach, regulatory implications as technical leader of a multidisciplinary team. To act as technical leader and Project manager
( when requested by project/ customer) of TT projects.
TECHNICAL KNOWLEDGE
Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on): - Technology Transfer: at least 5 years of experience in a TT team in at least one of the following role: Process Technology SME (alias process Manufacturing Science and Technology or Process Engineer) or Process Validation SME or coordinator of those team - Experience in project management in TT projects or similar context - Management or involvement in an average number of TT projects ( not less than 10 ) - Experience in manufacturing of complex pharmaceutical forms such as : aseptic process of drug product, lyophilized products, biological products, biotechnology/ biosimilar products (nice to have) - Aseptic Manufacturing and Media simulation study - Risk management - Documentation Management (SOPs, Specification, Records) - Deviations/Non-conformities management - Change Control ( nice to have) - CAPA process ( nice to have) - Equipment Validation ( nice to have)- Process Validation - Filter Validation - Computerized Systems Validation ( nice to have) - Data integrity.
EDUCATION AND/OR EXPERIENCE
The CAI TT Senior Specialist role requires a degree in Chemistry, CTF, Pharmacy, Biological Sciences, Biotechnologies, Chemical Engineering, or equivalent degree in the life-sciences field. At least 5 years of professional experience is required in the field of activity.
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CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country