Technical Transfer Manager Prague, Praha

Technical Transfer Manager

POSITION PURPOSE
Technical Transfer Manager is a team member of Industrial Projects department responsible for technical part of industrial projects running with 3rd party manufacturing sites, mainly transfers to CMOs. Technical Transfer Manager ensures that projects are executed in line with company’s priorities and will secure business continuity of particular products. Provides manufacturing technology expertise, advice and support in collaboration with CMOs being responsible mainly for technical risks management. Contributes to feasibility study performance, a smart contract preparation, project budget preparation and smooth project execution.
KEY RESPONSIBILITIES AND ACTIVITIES
- Contributes to processes and internal strategy of collaboration with CMO definition
- Manages the collaboration with technical transfer functions in CMO
- Conducts technical due diligence and assessment of CMO’s capabilities
- Contributes to the sourcing process for identification, evaluation and selection of CMOs, provides recommendation for Make-vs-Buy decisions
- Endorses projects in terms of transfer strategy, plan, timeline, resources
- Controls project execution from the technical point of view in close collaboration with the project manager
- Is responsible for supervision of technical risks management executed by respective CMOs.
- Ensures all technical data packages, GAP analysis, protocols, manufacturing records, reports, and other relevant documentation are aligned, compiled and reviewed by following the quality and documentation systems of respective CMOs.
- Is the key escalation point for technical matters in the projects, internally and with CMOs to secure that and product is relaunched without business interruptions
- Negotiates technical requirements and parameters with selected CMOs
- Contributes to project budget preparation for approval and its management during the technical transfer
- Provides leadership, guidance, expertise, scientific advice, consultation for matters related to pharmaceutical technology of the products in the company’s portfolio
- Leads/coordinates activities related to tech. optimizations, product robustness, troubleshooting, reformulations, new sources implementation etc.
QUALIFICATIONS AND EXPERIENCE
- University Degree in Chemistry or Pharmacy
- 6+ year experience in pharma manufacturing environment of which at least 3 years in technical transfers;
- Experience with a wide scope of technologies - solids, semi-solids and liquids, steriles, contained technologies (incl. hormons, cytotoxics), packaging technologies; experience with cosmetics, food supplements and medical devices is an advantage
- Excellent knowledge of the technical transfer process and its specifics
- Experience with risk management and risk mitigation measures
- Managerial experience in pharma production is a big advantage
- Experience in Quality, Regulatory, R&D is an advantage
REQUIRED SKILLS
Soft skills / Professional skills
- Business-orientation with scientific/ technology background (development and/or pharma technology and/or transfers)
- Knowledge of PM tools (e.g. risks management, tasks management, PM office)
- Basics from market intelligence, finance/ controlling
- Coordination and presentation skills
Competencies
- Business Focus
- Drive for Results
- Teamwork
- Ability to work in cross-cultural team
- Customer Service
- Embracing Change
- Quality of Work
- Communication and negotiation skills
Languages
- Fluent in English (company language)

Zajímavé nabídky práce v okolí: