Associate Scientist, Biologics Analytical Development - Reference Material and Critical Reagents

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We are searching for the best talent for an Associate Scientist, Biologics Analytical Development - Reference Material and Critical Reagents , located in Malvern, PA.

Purpose: The Associate Scientist, Reference Material and Critical Reagents (RMCR), is part of the Analytical Development (AD) Proteins organization and is responsible for delivering reference materials and critical reagents to support analytical testing for the lifecycle of the biologics portfolio. The Associate Scientist will be highly challenged in a fast paced, global, GMP environment supporting multiple biologics programs.

You will be responsible for:

• Successfully delivering on supply of RMCRs without impact to analytical testing timelines.
• Supporting storage and distribution of RMCRs globally.
• Managing preparation of RMCRs per protocol.
• Maintaining qualification and requalification schedules for RMCRs and collaborating with analytical testing labs to acquire the data necessary to prepare qualification and requalification documents and issue Certificates of Analysis.
• Collaborating and coordinating with analytical testing labs to ensure testing is executed to support RMCR activities to meet accelerated project timelines.
• Working with sites and statisticians to compile trending data as appropriate for reference materials and analytical controls.
• Authoring SOPs, protocols, and specifications to support project needs.
• Participating in initiatives for continuous improvement and future strategies.

Qualifications / Requirements:

Education: M.S. in Chemistry, Biology, Biochemistry, or a related field with at least 1 year OR B.S. with at least 3 years of relevant industry experience is required.

Required:

• Experience with analytical methods and solid understanding of the reference material and critical reagents associated with method execution.
• Highly self-motivated and eager to learn.
• Strong technical writing experience (SOPs, protocols, and qualification reports).
• Highly organized and strong attention to detail to plan, implement, and document work with limited supervision.
• Excellent interpersonal skills with the ability to adapt effectively to constantly evolving organization issues, structures, and dynamics.
• Strong written and verbal communication skills to collaborate with internal teams, external vendors, and stakeholders.
• Ability to lead projects and to collaborate with multiple sites to ensure timely completion of activities under accelerated project timelines.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, OneNote, and Copilot).

Preferred:

• Knowledge of cGMP regulations, FDA guidance, and process excellence methodology.
• Experience with reference material and critical reagent sourcing, qualification, and management.
• Knowledge of automation systems and digital platforms (i.e., LIMS, BIOVIA).
• Basic understanding of data trending and experience with statistical software applications (i.e., JMP, Minitab).
• Experience with Document Management Systems (i.e., TruVault, Documentum).

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