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Coriolis Pharma · 3 days ago

Scientist I / II (f/m/d) - In-Use studies and PPM Testing

North Carolina, United States

Full-time

Onsite

Mid, Senior Level

3+ years exp

Coriolis Pharma is a company focused on enabling the next generation of biopharmaceutical therapies. The Scientist I / II role involves contributing to formulation development and analytical strategies, transforming scientific questions into analytical insights, and supporting client projects while ensuring compliance with GMP standards.

Pharmaceutical

Culture & Values

Hiring Manager

Dominik Schwemmer

Responsibilities

Be part of project teams for client projects (e.g., liquid/lyophilization formulation development, comparability and stress testing, storage stability study) as assigned by the superior with special focus on in‑use stability studies and primary packaging material (PPM) testing:

Work as (i) 1st, 2nd project leader and/or (ii) team member for projects

Contribution/responsible for the development of work plans, testing procedures and/or amendments for customer projects

Correctly, timely and independently plan and execute formulation preparation / analytical testing / experiments

Independently perform analytical method transfer/implementation

Demonstrate solid understanding of performed analytical methods and be able to apply the knowledge to interpret the data

Perform data analysis and subsequently put data into context for data presentation and/or report

Support scientific discussion in client meeting

Appropriately act on unforeseen events

Be specialist / expert on several instruments / analytical methods / application areas (e.g., able to perform method development, interpretation of data, troubleshooting and training of new users)

Implementation of new analytical equipment / technologies and application of the methods within client projects

Support on-boarding of new team members

Liaise with superior on training needs

Act as mentor

System Owner for laboratory equipment: responsible for operator training, equipment maintenance, calibration and qualification

Ensures that GRP rules are followed and documented

Ensures general laboratory cleanliness

Other duties as assigned by superior

Qualification

Analytical method developmentHPLC/UPLC analysisIn-use stability studiesPPM comparability testingBiopharmaceutical formulationEquipment commissioningLIMSBiophysical characterizationEagerness to learnIntercultural team playerCommunication skillsTime managementProblem-solving skillsHands-on mentality