Sample Management & Stability Coordinator in Cambridge, MA

Coordinator – Sample Management and Stability

DURATION: 6 Months from start date

100% ON SITE

Job purpose:

• The coordinator Sample management and Stability is an individual contributor capable of independently executing writing assignments involving a thorough understanding of analytical R&D processes and procedures.
• He/she would be expected to support the Sample management and the stability process and related documents in collaboration with Analytical Product Leaders, ARD technical experts, TRD experts, commercial QC, and QA.
• The Coordinator has the ability to plan and prioritize with minimal supervision.

Your Responsibilities:

• You support the sample management activities for clinical material at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.
• You support lab activities for sample reception, aliquoting and dispatching for clinical material at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.
• You support the Stability process for clinical material at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.
• You support the stability report, trending analysis, consistency table with Analytical Product Leaders, ARD technical experts, External Third Parties and Quality.
• You manage Unplanned events in line with stability process, sample dispatching or SAP master data process.
• You ensure the consistency and quality level of all documents that are issued requiring minimal quality check and rework. Ensures quality assurance for all written materials within scope
• You demonstrate skills in effectively managing assignments (including multiple priorities and responsibilities) and assures assigned milestones are achieved within the established time frames.
• You have the ability to work within a complex matrix structure (with Analytical Product Leader, Technical Development Leader, Platform heads, technical experts) and drive the process. Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in project delivery.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• MS OR BS with 2+ years of experience.
• Degree in Chemistry/Biochemistry/Biology with 2 years’ experience in pharmaceutical environment
• Possess general computer literacy.
• Possess excellent command over English language (verbal and written).
• Proficiency in written and spoken English.

Preferred qualifications:

If you have the following characteristics it would be a plus:

• Written and spoken local language.
• Sound scientific methodology, critical thinking and problem-solving skills.
• Ability to integrate and work in a team.
• Demonstrated ability to be proactive and take initiative
• Flexible, and easily adapt to new/unexpected situations.

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