TECH OPS & QUALITY - STABILITY SPECIALIST

Tech Ops & Quality – Stability Specialist Location: Cambridge, Massachusetts Category: Quality and Compliance Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site 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 Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. #J-18808-Ljbffr Planet Pharma