JOB DESCRIPTION OVERVIEW
Analytical and Stability Scientist, in the R&D setting will be responsible for supporting the Analytical and stability capability in the Wellbeing Collective in relation to a new product development life cycle. The role will have heavy cross functional interactions and coordination across product development team, quality, regulatory and external contract labs to ensure timely delivery of the objectives.
The role will be required to work on the global development projects in relation to analytical and stability function from assessing new co-manufacturer s capabilities, navigating function related work-streams. It will also require to establishing network of external partners & collaborators basis international market scenario.
KEY ACCOUNTABILITIES
Participate in project teams to support with following analytical and stability related activities:
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Identify and work collaboratively with contract laboratories to outsource activities related to analytical method development/validation for actives like botanicals and other chemical markers in complex matrices leveraging industry relevant emerging trends for new markers.
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Draft study plan & protocol for Pivotal, In-use, Bulk stability, MSI, etc., Ensure relevant formulation inputs are reviewed, and valid scientific approaches are followed throughout stability study implementation stages. Manage stability operational aspects including logistics, study initiation, sample-pull, testing, trending, extrapolation (assessing organoleptic, physical & chemical parameters), chamber management, data review, reporting, invoicing, study termination and disposal. Conduct data review, technical justifications and prepare study reports to assign product shelf life.
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Design matrix or product specific method validation and stability studies using industry standard practices or guidelines.
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Interpret stability & method validation data to draw conclusions. Troubleshoot analytical methods to address matrix specific challenges and lead method optimization using a systematic gap analysis approach.
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Additional analytical and stability support for on-going US and other projects as needed requirements. Design and execute analytical investigations and propose root cause analysis.
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Support different calculations for product formulation, specification and R&D development work requirements.
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Timely implementation of key deliverable for the project. Timely recording, reporting and interpretation of data for method development, validation & transfer related activities for new products (formats like gummies, soft-gels, capsules or powders) for Wellbeing category.
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Help problem solving existing business challenges / regulatory issues. Support product investigations for Out of spec/trend results.
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Establish the analytical and stability documentations. Keeping a good documentation track of all the data collected.
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Follow GMPs, SHE requirements and other applicable regulations. Ensure timely completion of all the SHE assigned trainings and to perform all daily tasks in accordance with global SHE standards and policies. Report any unsafe acts or conditions that are observed in the workplace and participate in any assigned safety related processes and activities .
KEY EXPERIENCE AND SKILLS:
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Bachelor s degree in chemistry/science (preferred Analytical Chemistry), Masters, PHD is preferred (10+, 8+, 5+ years respectively) of relevant industry experience in Analytical Sciences and handling botanical ingredient s assays.
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Hands-on experience with method development and validation procedures for one or more categories such as dietary supplements, foods, cosmetics, drug products.
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Expertise in stability study management and operating as per global stability guidelines (ICH/WHO, etc.).
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Demonstrate ability to apply scientific principles and techniques to assigned projects.
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Have working and/or hands-on knowledge and experience in techniques such as HPLC, LC-MS, GC, ICP, spectroscopy and other analytical techniques preferably relevant to micronutrients, botanicals, and novel ingredient testing, etc.
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Thorough knowledge of standard compendial monographs such as USP, BP, EP, ICH, ISO, FASSI, IP etc. for Vitamins, Mineral, Botanical and other applicable actives.
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Strong in GMPs, good laboratory and good documentation practices.
GENERAL SKILLS/COMPETENCIES:
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Excellent written and oral communication skills, ability to work well with others.
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With appropriate supervision, must possess the ability to present information to a technical audience.
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Demonstrate problem-solving ability using innovative thought and good scientific judgment.
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Project Management skills and proven ability to handle multiple priorities in an ever-changing business environment.
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Must demonstrate flexibility in work hours to cover India/US time zones, open-mindedness and diversity support overall business targets and project objectives.
WHAT YOU LL NEED TO SUCCEED:
