Stability Specialist

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Stability Specialist

Location: Cambridge, MA, 02147

Duration: 2 Months

Pay rate: $50/hr. - $70/hr. On W2

Job Description:

Job 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.