Specialist Monography and Projects

The specialist Monography and projects is an individual expert contributor capable of independently executing writing assignments involving a thorough understanding of analytical R&D processes and procedures. He/she would be expected to manage the stability process and related documents in collaboration with Analytical Product Leaders, ARD technical experts, TRD experts, commercial QC, QA and Regulatory Affairs.

The specialist as the ability to plan and prioritize with minimal supervision.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Support the Stability process using a QbD approach, for clinical material at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.
• Manage the stability intermediate or final report, trending analysis, consistency table, stability plan modification, external and internal COA and stability usage decision in SAP with Analytical Product Leaders, ARD technical experts, External Third Parties and Quality.
• You can support the definition of the control strategy for all Ph1 to Ph3 projects for GMP, Toxicological, biologicals standard, Reproducibility, Engineering, and in-process batches and in agreement with appropriate analytical project leader (APL) and key stakeholder (RA/QA/producer)
• Ensure the consistency and quality level of stability documentation that is issued requiring quality check (QC).

• 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 with 3+ years of experience OR BS with 6+ years of experience.
• Degree in Chemistry/Biochemistry/Biology or Administrative field with 5 years' experience in pharmaceutical environment
• Experience in supporting Analytical Product Leaders and ensures quality assurance for specific documentation for regulatory purpose (Stability reports)

• Have experience with checking the quality level of all documents that are issued requiring minimal quality check and rework and ensuring the quality assurance for all written materials within scope and in line with internal or external procedures.

• Have knowledge of internal processes/procedures.

Preferred Qualifications:

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

• Possess general computer literacy.
• Possess excellent command over English language (verbal and written).

• Sound scientific methodology, critical thinking and problem-solving skills.

• Ability to integrate and work in a team.

• Demonstrated ability to be proactive and take initiatives

• Flexible, and easily adapt to new/unexpected situations

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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