Senior Specialist, Stability, Analytical Development and Clinical QC

This is what you will do:

This position is required to perform assigned tasks including stability protocol review, trend analysis and investigation assessments to support Genomic AAV Stability activities for Alexion’s clinical phase candidates from development through Phase III and support Commercial Submission. This position will manage all the data trending and support related technical reports and regulatory filings. This position will also ensure stability data integrity per regulatory requirements. The Senior Specialist will work in collaboration with members of Clinical Stability; Analytical Development & Quality Control; Quality Assurance; Reg/CMC and other members of PDCS; as well as external vendors, as required. The ability to accurately and independently generate trends, reports, and CMC section content for regulatory filings pertaining to stability is a crucial requirement of this position.

You will be responsible for:

• Serve as stability SME for genomic development programs and attend meetings as assigned.
• Work with Analytical lead and CMO to determine lots needed for stability, review stability protocols and SOPs in support of shelf-life and regulatory filings.
• Review CMO and internal storage, stability initiation, protocols, investigations for OOS/OOT results, release and stability testing and applicable quotes; perform data audit and verification as needed.
• Manage regular receipt of stability results from CMO and internal testing labs.
• Track and trend stability data for multiple products in JMP for identification of OOT, expiry support and extension, stability review presentations and regulatory filings.
• Support stability related internal mirror investigations, shipping or storage deviations and assessments as needed.
• Serves as lead for genomic stability data management. Provide sound scientific feedback on assay performance based on data collection/trending and understanding of testing assays. Support specification changes as needed.
• Document stability results with a strong attention to detail; able to recognize trends outside of expected results and ability to escalate findings as needed.
• Create and maintain systems for stability pull schedules and sample pulls.
• Review CMO stability final reports and product update reports in support of shelf-life recommendations and regulatory filings.
• Perform all job functions in compliance with cGMPs and maintain accurate and legible records.
• Ensure training is current for all job functions performed. Attend all required Company training.

You will need to have:

• Master’s degree or bachelor’s degree in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering, or related discipline)
• Direct relevant experience in pharmaceutical industry (3+ years for master’s degree; 5+ years for Bachelor’s degree)
• Direct relevant experience in AAV pharmaceutical development (1+ year)
• Strong working knowledge of governing documents/regulations for pharmaceutical stability (1+ year)
• Knowledge of GxPs and their application in the pharmaceutical environment
• Ability to interact with cross-functional teams as stability SME.
• Ability to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual can provide updates and tracking on his/her tasks.
• Ability to communicate findings effectively to colleagues within and outside of the group through presentations and technical reports.
• Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience with pharmaceutical technical writing
• Experience with SAS JMP or other statistical software
• Experience with Laboratory Information Systems (LIMS)

The annual base pay (or hourly rate of compensation) for this position ranges from $110,687 to $166,031. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.