Assoc Scientist Pharmaceutical Sci|ALX

Stability Associate II, Analytical Development and Quality Control

Location:

New Haven, CT – 100% onsite.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life‑changing medicines. In‑person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

• Responsible for all aspects of on‑site stability sample storage and sample management
• Conduct Stability sample pulls at scheduled time points according to approved stability study plans
• Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
• Perform data entry/review within paper‑based and electronic systems
• Point‑of‑contact between on‑site testing labs and stability group
• Author stability Protocols, Reports, SOPs and Quality documents as required
• Work with internal stakeholders to provide testing requirements and obtain completed analytical test results
• Track stability results generated internally and at external CMOs/ CLOs
• Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as required
• 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

• Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience)
• Knowledge of GxPs and their application in the pharmaceutical environment is required
• Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks
• Ability to interact with cross‑functional teams while representing the stability group
• Able to navigate external vendor sites and portals for data extraction and review, as needed
• Able to communicate findings effectively to colleagues within and outside of the group through presentations
• Proficient with various MS Office programs, including Word, Excel, Outlook, and Power Point
• The ability to communicate verbally and in a written format is required
• Able to understand and follow written procedures
• The duties of this role are generally conducted in an office/lab 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.

• Working knowledge of governing documents/regulations for pharmaceutical stability
• Previous technical writing experience
• Previous experience with SAS JMP or other statistical software
• Previous experience with Laboratory Information Systems (LIMS)

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.