Tech Ops & Quality - Stability Specialist

Responsibilities

The Contractor, Stability will be responsible for stability support of siRNA drug substances, drug products, intermediates and critical raw materials. Major contributor of data to CMC sections of regulatory filings. Provide inter-departmental support by ensuring continuous supply and life-cycle management of stability programs internally and at contract manufacturers/laboratories.

Summary Of Key Responsibilities

• Organize the stability testing program for specified developmental and clinical programs.
• Contribute to the design of, and analyze data obtained from special use studies including stress and forced degradation, photostability, excursion management, compatibility, and in-use studies.
• Monitor team performance against plan and act where targets could be missed.
• Prepare stability plan with stakeholders.
• Author and review stability SOPs and protocols in accordance with company and regulatory guidelines.
• Review, analyze, and trend stability data, assist in deriving stability specifications. Provide stability expertise to risk assessment process.
• Author and review stability reports.
• Author and contribute analytical data to stability sections of regulatory submissions. Assist with responses to agency requests.
• Contribute to stability deviation and out of trend process.
• Contribute substantially to the interpretation of data and subsequent impact to methods/product (e.g., participation in statistical process control (SPC), control charting/trending, etc.).
• Expected contributions to general laboratory operations including review of data, authorship/review of technical documentation, and inspection readiness. Provide QC technical support as needed.
  
  

Requirements

• MS or PhD. in Chemistry, Biochemistry, Pharmacology or related discipline. Advanced degree preferred.
• 4 years of relevant experience in a stability related function. Previous Quality Control / GMP experience is highly preferred.
• Preferred – experience with HPLC and physico-chemical test methods of oligonucleotides. Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.
• Strong skills in the application of statistical methods.
• Direct involvement in material specification setting and justification is preferred.
• Experience working at a multi-site company and/or with CMO/CTLs is helpful
• Strong verbal and written communication skills, including the ability to present stability data cross-functionally.
  
  

Pay ranges between 556-66/hr based on experience