DescriptionYour Role:The
Lead Analyst, Quality Control will lead and perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment.
Key Responsibilities:
- Lead and coordinate filled visual inspection for product lot release.
- Lead and execute assay qualification, method validation, special studies, investigations, method development and tech transfer projects.
- Work independently and navigate testing and analytical instrumentation with minimum instruction.
- Act as Subject Matter Expert for multiple testing methodologies and instruments.
- Perform and review routine cell maintenance, cell-based assays, ELISA, electrophoresis (SDS-PAGE), immunoblot, and qPCR testing of drug substance and drug products with strict adherence to written analytical test procedures.
- Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
- Provide guidance to Jr. Analysts and Analysts regarding lab work.
- Review, revise, and write test methods, standard operating procedures and may perform trending analysis.
- Write study protocols and reports; train other analysts; collaborate with other departments in developing, revising, and implementing QC procedures and policies.
- Stay abreast of company cGMPs and applicable industry regulations.
- Participate in regulatory inspections.
- Actively participate in departmental continuous improvement efforts.
- Participate in regulatory inspections.
- Perform other duties as assigned.
Minimum Qualifications: - Bachelor's degree in biology, biochemistry, chemistry, or equivalent scientific field.
- Minimum 6 years of relevant hands-on experience working in a GMP environment.
- Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
- Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience.
Preferred Qualifications: - Experience with cell-based assays, qPCR, electrophoresis, chromatography, aseptic techniques, and assay validation/qualification.
Position Type/Expected Hours of Work:This role is a full-time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $46.15 - $57.69 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are: - You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
