Job Description Summary

-Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. -Management Track -Lead a team for the development of pharmaceutical/biological/cell-gene therapies working in a multidisciplinary environment. Execute and support developing the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, NTO and NIBR plans
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.

 

Job Description

• 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

 

Skills Desired

Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model