Sumar
Lead and manage all project/local network activities and contribute to strategic decisions; design, plan, perform, -document and interpret scientific/developmental experiments or GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures within a multifunctional project team coordinated by a Project Manager/Leader; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.
About the Role
Key Responsibilities
- Oversee and lead all activities of assigned teams /projects; meet customer needs.
- Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information security; lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures.
- Evaluate and interpret results, draw relevant conclusions; supervise project related activities; perform complex tasks without having established procedures.
- Oversess and may also write protocols, scientific reports, lab procedures or process.
- related SOPs; write scientific documents intended for external partners or for generation of registration documents; interact with authorities -Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
- For technical development units: Develop complex methods (lab or plant); lead the optimization of project related scientific /technical activities or processes, co-ordinate local team(s); guide development and implementation of new technologies.
- For GMP units: ensure compliance to cGMP.
- For technology focused role: Provide scientific and technical guidance; actively foster knowledge exchange.
- Develop, mentor and coach other scientific associates; present scientific /technical results internally and contribute to publications, presentations and patents.
- For project-focused role: Lead assigned teams; represent own technical function in teams and fulfill all project tasks and responsibilities related to the own discipline -Broadly uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways -Contributes to many cost center goals and objectives; may contribute to service line goals .
- Develop detailed plans and timelines with the manager, develop formulation strategies and plans for designated projects from development to cGMP manufacture.
Essential Requirements:
- Ph.D. in Analytical Chemistry or an equivalent qualification with a minimum of 4–6 years of experience, or M. pharm/M.Sc. with at least 8-12 years of experience within the pharmaceutical industry, specifically in analytical development.
- Understanding of general regulatory and quality expectations. GMP experience is a must
- Good scientific background, communication skills including presentation and scientific/technical writing.
- Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc.
- Expertise in liquid chromatography separation techniques and dissolution techniques is a pre requisite. Experience in Mass Spectrometry (ranging from mass confirmation to actual quantitative analysis of impurities and sequencing) is an asset.
- Solid GMP experience (mandatory). Sound understanding of regulatory and quality expectations. Strong scientific foundation with excellent communication skills, including presentations and scientific/technical wriing skill
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.