Quality Control Scientist - Manufacturing

Description

Phlow is seeking a Quality Control Scientist, Manufacturing to support Quality Control activities at our pharmaceutical manufacturing facility in Petersburg, Virginia. This hands-on laboratory role will primarily provide in-process analytical testing in support of the development, scale-up, and manufacture of active pharmaceutical ingredients (APIs). The Quality Control Scientist will work closely with Manufacturing, Process Development, Manufacturing Science and Technology (MS&T), and Quality Assurance to provide accurate and timely analytical results that support manufacturing and process decisions. The candidate will personify Phlow’s shared values and culture and will work with the highest standards of safety, integrity, transparency, and ethics. 

This position requires flexibility to work varying shifts and schedules based on production needs. Because in-process testing must align with manufacturing activities, the individual must be able to adjust working hours as production schedules change, including early mornings, evenings, weekends or other non-standard work hours. 

The salary range for this position is $25.00 per hour to $30.00 per hour, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.    

Requirements

• Perform in-process testing of samples generated during API development, scale-up, engineering, and manufacturing activities. 
• Execute established analytical methods to evaluate reaction progress, intermediates, process streams, and API samples. 
• Provide accurate and timely analytical results to Manufacturing and technical teams to support process decisions. 
• Provide QC laboratory coverage aligned with manufacturing schedules, including flexibility to work varying shifts or non-standard hours as production needs change. 
• Operate, maintain, and troubleshoot laboratory instrumentation used for in-process and QC testing. 
• Prepare samples, standards, reagents, mobile phases, and other laboratory solutions according to approved procedures. 
• Perform chromatographic, spectroscopic, wet chemistry, and other routine analytical testing. 
• Review analytical data for accuracy, completeness, and compliance with established procedures. 
• Maintain accurate, complete, contemporaneous, and traceable laboratory records. 
• Assist with analytical method transfer, verification, qualification, and validation activities. 
• Support investigations of atypical, out-of-specification (OOS), and out-of-trend (OOT) analytical results, as appropriate. 
• Troubleshoot routine analytical instrument issues and coordinate maintenance or service when necessary. 
• Collaborate with Manufacturing, Process Development, MS&T, Quality Assurance, Engineering, and other technical teams. 
• Work safely when handling APIs, intermediates, solvents, reagents, and other chemicals. 
• Perform activities in accordance with applicable SOPs, cGMP requirements, and data-integrity expectations. 

Analytical Instruments & Equipment 

• Candidates should have 2-5 years of hands-on experience using analytical laboratory equipment, ideally including: 
• High-Performance Liquid Chromatography (HPLC/UPLC) for assay, purity, reaction monitoring, and related-substance testing. 
• Gas Chromatography (GC), including residual-solvent and process-related analyses. 
• Karl Fischer titration for moisture/water determination. 
• UV-Visible and FTIR spectroscopy. 
• pH meters, analytical balances, and automatic or manual titration equipment. 
• Laboratory sample-preparation equipment, including pipettes, sonicators, centrifuges, and filtration systems. 
• Experience with GC headspace, LC-MS, GC-MS, Raman, or other Process Analytical Technology (PAT) is a plus. 

Qualifications 

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline. 
• 2-5 years of hands-on analytical laboratory experience in pharmaceutical, API, chemical manufacturing, CDMO, or another related environment. 
• 2-5 years of practical experience operating analytical instrumentation, preferably including HPLC and GC. 
• Experience executing established analytical methods and interpreting analytical results. 
• Strong laboratory documentation and data-integrity practices. 
• Ability to troubleshoot routine analytical and instrumentation issues. 
• Must have the flexibility to work varying shifts and adjust working hours based on the production schedule. Scheduled hours may change depending on production and in-process testing requirements. 
• Strong organizational skills and the ability to respond effectively to changing priorities in a manufacturing environment. 
• Strong interpersonal and written and verbal communication skills. 

Preferred Qualifications 

• Experience supporting API/drug substance manufacturing or development. 
• Hands-on experience performing in-process testing in direct support of manufacturing operations. 
• Experience working in a cGMP-regulated pharmaceutical environment. 
• Knowledge of ICH and USP requirements applicable to analytical testing and API manufacturing. 
• Experience with chromatography data systems such as Waters Empower or similar platforms. 
• Experience with analytical instrument qualification, calibration, and maintenance. 
• Experience with analytical method transfer, verification, or validation. 
• Previous experience in an API manufacturer, pharmaceutical manufacturer, CMO, or CDMO environment. 

Physical Requirements 

• Constantly required to see and utilize computer screens, monitors, analytical instruments, and laboratory documentation to perform job duties. 
• Frequently required to talk or hear to communicate with employees, vendors, and others. 
• Frequently required to reach with arms and hands, perform repetitive motions, and use finger dexterity to operate laboratory equipment and computer systems. 
• Frequently required to stand or work at laboratory benches for extended periods and occasionally sit or walk in laboratory, office, and manufacturing environments. 
• Ability to wear required personal protective equipment and safely handle laboratory chemicals, solvents, samples, and equipment. 
• Occasionally lift and/or move up to 25 pounds. 
• Must be able to work varying shifts and non-standard hours based on manufacturing and production needs.