Quality Control Analyst Ii/iii (release And Stability Group)

Serán BioScience is searching for an experienced chemist to join the Release and Stability group as an Analyst II/III within the Quality Control department. Quality Control Analysts play a key role in supporting the manufacturing of novel pharmaceutical therapies within GMP environments. Primary responsibilities include providing meticulous support for laboratory operations, conduct testing, and participate in method development and transfer. Successful candidates will demonstrate expertise in utilizing specialized laboratory equipment, techniques, and methodologies for technical assessments and data analysis purposes.

Duties and Responsibilities

• Conducts appearance testing, solution preparation, and pH measurement
• Conducts raw material sampling, AQL, and Identification Testing (FT-IR)
• Drafts stability tables and sets-up stability studies
• Performs tests with analytical equipment (e.g., disso, KFV, HPLC, XRPD, mDSC)
• Conducts technical data review on training procedures
• Logs-in samples and standards
• Conducts peer review and approval of data collected by QC Analysts
• Leads laboratory initiatives or programs
• Trains Analysts on internal procedures and test methods
• Performs statistical analysis
• Utilizes change control systems and Inventory management
• Acts as an SME for critical processes and testing
• Leads day to day activities acting as a backup to the supervisor as needed
• Regularly interfaces with clients on technical matters
• Interfaces with laboratory management as technical lead for OOS investigations
• Supports tracking and reporting laboratory performance metrics
• Performs other related duties as assigned

Required Skills and Abilities

• Demonstrates intermediate to advanced expertise with analytical equipment (e.g.disso, KFV, HPLC, XRPD, mDSC)
• Excellent verbal and written communication skills
• Ability to collaborate, train, and work in cross-functional teams
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Strong math, analytical, and problem-solving skills
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Proficient with Microsoft Office Suite or related software

Education and Experience

• Bachelor’s degree in a scientific discipline or related field, with 2 years of hands-on lab experience preferred; or
• Master’s degree in a scientific discipline or related field, with 1 year of hands-on lab experience preferred
• Requires 1 year of GMP experience

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Prolonged periods of sitting or standing in laboratory environment
• Must be able to lift up to 25 pounds at times
• Motor skills required for basic laboratory operations