Expert, Science & Technology

AI in this role

Design and execute scientific experiments and analytical method validations for drug substance and product development.

limschromatography

scientific-experimentsanalytical-methodologygmpglpformulation-development

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 within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Management TrackLead a team for the development of pharmaceutical/biological/cell-gene therapies working in a small manufacturing plant environment. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans. -SANDOZ: -Associate Scientist: Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery of drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Scientist: -Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery 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 SZ strategies and goals -Senior Scientist: Design, plan, perform -document and interpret scientific/developmental experiments and GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

Job Description

Key Responsibilities

Responsible for performing method feasibilities and validation of robust analytical methodologies applied to innovative oral solid dosage forms. Strong experience in chromatography techniques and experience in handling techniques like Dissolution, Titrator etc., used for OSD testing is a pre-requisite.
Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.
Accountable for documentation and submission of raw data in an appropriate data system (for e.g., LIMS test activation and results entry).
Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
Generate and support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.
Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope.

Minimum Requirements

Ph.D. in Analytical Chemistry or an equivalent qualification with a minimum of 1–3 years of experience, or M. pharm/M.Sc. with at least 8 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

Skills Desired

Materials Science, Process Simulation, Technical Writing, Waterfall Model

How we rate this

Expert, Science & Technology at Novartis rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.

Prepare for this job

A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.

Skills and AI tools this role asks for

Scientific ExperimentsAnalytical MethodologyGmpGlpFormulation DevelopmentLimsChromatography

Questions you could be asked

Tell me about a project where scientific experiments was part of your work. What did you do?
Tell me about a project where analytical methodology was part of your work. What did you do?
Tell me about a project where gmp was part of your work. What did you do?
Tell me about a project where glp was part of your work. What did you do?
Tell me about a project where formulation development was part of your work. What did you do?

Adapt your resume

List these exact terms on your resume: Scientific Experiments, Analytical Methodology, Gmp, Glp, and Formulation Development. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.

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