Drug Product Project Leader, Parenteral Dosage Form Projects

Job description

Job Description

Lead, represent, manage and support departmental project team for Parenteral Dosage Form projects. Support teams with strong strategic focus, scientific and technical expertise and quality awareness. Foster strong team spirit and promote knowledge exchange within and between teams. Formulate and implement a sound project strategy incl. contingency planning and risk assessments involving functional experts. Proactively manage the interactions of project related activities between own function and other departments inside and outside of Technical Research & Development. Ensure alignment with other departments and functions and 3rd parties as appropriate. Proactively communication of overall project related information in a timely manner to the appropriate management level. Ensure Project team objectives are in alignment with functional objectives.

- Actively participate in teams, projects, networks /platforms. Fulfill all related tasks and responsibilities related to own discipline Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level to any other relevant project team member(s)
- Design, plan, perform and monitor all assigned activities Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Support and assign associates in specific projects/networks. Coach on target dates and priorities
- Proactively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects/networks
- Advise team members and work according to appropriate SOP’s, GLP, DQP, GMP, OQM, HSE, ISEC and Novartis guidelines Interpret results, evaluate data, draw relevant conclusions and write reports
- Contribute to optimization of scientific/technical activities in assigned projects, network/ platforms/ processes.
- Contribute to risk analyses /peer review and process challenge meetings
- Generate and select most appropriate scientific documents to hand over to internal and/or external partners (TechOps, authorities, other companies)
- Proactively support generation of international registration documents. Interact with authorities where appropriate Interact/collaborate with Research/other functions to facilitate transfer of knowledge and deliveries of DS/DP
- Actively support TRD on audits and inspections/Due diligence teams Provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate
- Proactively contribute to setting, updating and monitoring of team goals. Translate team goals into daily work
- Support and facilitate the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Drive cultural evolution and change management

Desired profile

Minimum requirements

Advanced degree in Pharmaceutical Technology or scientific relevant discipline (Ph.D. or equivalent)

Fluent in English (oral and written). Desirable knowledge of site language.

Professional Experience:
1. Successfully demonstrated several years (minimum of 3 years) of directly related experience.
2. Recognized expertise in a specific area.
3. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs.
4. Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications.
5. Thorough understanding of development processes in a specific function.
6. Profound literature search skills.
7. Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
8. Proven leadership skills.
9. Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
10. Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.