Technology Transfer Manager (m/f)

Job description

Job Description

Lead and manage the technology transfers of DP manufacturing processes (and accompanying analytical methods) from lab/pilot scale to clinical and commercial manufacturing sites for assigned projects.

1. Lead, manage, and support the technical transfer team of the transferring site and support the respective subordinate functional subteam(s) in line with Novartis values. Set priorities for the transfer team; coach, mentor, and motivate Subteam Members as appropriate and provide input on performance of team and its members, if requested by line functions.

2. Elaborate scientifically sound technical transfer process with pharmaceutical development group and other members of the transfer team considering the complexity of all aspects. Ensure state of the art in Transfer process and documentation complying with all relevant guidelines. Develop contingency plans, compile/maintain transfer masterplan including technical product strategy, constructively challenge other functional plans and ensure that overall project plan is considered in the transfer master plan.

3. Formulate the transfer strategy, integrate it into the overall project strategy and with 3rd parties, and ensure cooperation with other departments, functions and 3rd parties. Take overall responsibility and lead technical transfer objectives

4. Create, ensure implementation, and monitor progress of the respective transfer master Plans. Adapt project strategy and prioritize project activities, according to agreed upon timelines.

5. Lead and manage all activities of the transferring site of transfers of DP Processes to clinical and commercial manufacturing sites for assigned projects as a single point of contact in all phases of a transfer (pre-transfer, transfer and post-transfer phase).

6. Proactively communicate overall project strategy, key issues, and any other critical topics in a timely manner to the appropriate management level within TECHNICAL Line Functions and to the project team(s).

7. Contribute and support strategies for site selection of TechOps; actively contribute to resource allocation / outsourcing strategies.

8. Represent Biopharmaceutical Technical Development in Due Diligence teams for biopharmaceutical projects or business opportunities. Carefully assess and proactively communicate to the overall Due Diligence team and the TECHNICAL Line Functions, the technical benefits and risks of the analyzed project(s) / business opportunities in straightforward and clear language.

- Meeting timelines and milestones (first-time-right) of transfer activities according to project objectives. o Successful production of scheduled batches o Timely release of produced batches for clinical studies o Successful process validations o Availability of production related documents as appropriate for respective activity.
- Implementation of state-of-the-art processes

- Quality, timelines and documentation of transfer process progress: Documentation available on time and of high quality (e.g. transfer plans and reports, risk assessments, technical documentation packages, minutes). Call for development reports stability/comparability study protocols & reports.

- Timely, reliable, and accurate information / communication about project specific issues within technical units and to key stakeholders

- Adequate budget and resource management for all assigned projects according to guidance given by technical unit management.

- Ensure that project team follows Novartis guidelines and meet safety, environmental, GxP and regulatory guidelines (e.g. as measured by successful Pre

- Approval inspections and other audits, approval of CMC sections of IND/IMPD).

- Timely availability and storage, accuracy, and completeness of key-source documents and regulatory documents (process validation reports). Adhere to Novartis standards, in particular quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.

Desired profile

Minimum: Advanced degree in scientific or relevant discipline or equivalent

Desirable:Excellent English required (oral & written). - Broad experience (at least 4 years) in TECHNICAL Line Functions (e.g. several years of experience as head of laboratory or equivalent in a production unit), including at least 2 years as member of functional sub-team or equivalent experience from external company or other line function. - Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TECHNICAL Line Functions or equivalent experience from external company or other line function. - Regularly demonstrated active contributions to matrix teams with the necessary strategic thinking.

Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labor agreement, we advise you that the minimum gross annual salary for this role is EUR 48.020 ,-.