Planet Pharma · 11 hours ago
Stability Associate II, Analytical Development and Quality Control
New Haven, CT
Full-time
Onsite
New Grad, Entry LevelPlanet Pharma is a company that focuses on pharmaceutical development, and they are seeking a Stability Associate II to support stability activities for clinical phase candidates and commercial products. The role involves managing stability samples, conducting stability pulls, and collaborating with various internal and external teams to ensure compliance and quality in stability testing.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for all aspects of on-site stability sample storage and sample management
Conduct Stability sample pulls at scheduled timepoints 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
Qualification
Required
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 PowerPoint
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
Preferred
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)
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase