Job Description

The Associate Scientist will be responsible for performing analytical testing of siRNA drug substances, drug products, intermediates, and critical raw materials using UV spectrophotometry, osmometry, water content titration, and other chemistry instruments. Will also assist with collection, trending, and archival of data, in preparation for technical reports and regulatory filings. Provide inter-departmental support by ensuring continuous supply and life-cycle management of stability programs internally and at contract manufacturers.

Summary of Key Responsibilities:

• Perform testing of stability, stress, forced degradation, photostability, excursion management, compatibility, and ASAP studies.
• Prepare and perform set downs of study plan with stakeholders.
• Analyze and trend stability data, archive data.
• Contribute analytical data to stability sections of regulatory submissions.

Accountabilities:

• On-time and compliant completion of stability data to support clinical supply and product registration.
• Support regulatory submissions with stability data.

Hiring Requirements: Knowledge / Experience / Skill:

• BS in Biology, Chemistry, Biochemistry, Pharmacology or related discipline.
• 1+ years of relevant experience in an analytical laboratory setting. Previous Quality Control / GMP experience is preferred.
• Preferred – experience with physico-chemical test methods of oligonucleotides. Alternatively – experience with physico-chemical test methods of oligosaccharides or proteins.
• Experience working at a multi-site company and/or with CMOs is helpful.

Competencies:

• Ability to write clear technical documents and provide meaningful presentations.
• Ability to work independently and in compliance with company policies and regulatory guidelines.
• Excellent team skills, organization, and strong interpersonal communication skills (written and verbal).

Scope:

The Associate Scientist Stability will be responsible for stability support of developmental and clinical siRNA drug substances, drug products, intermediates, and critical raw materials.

Physical / Environmental Factors:

• Must be able to adhere to all laboratory safety requirements.

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