Quality Control Scientist I/II, In-Process Control- Day Shift

Serán BioScience is looking for a scientist with laboratory experience to support manufacturing of pharmaceutical drug products within our In-Process Control group. As a scientist within the Quality Control department you will work alongside a team of scientists and operators to ensure the highest quality product by testing raw materials and production equipment within GMP manufacturing and laboratory environments. Qualified candidates will demonstrate expertise in utilizing specialized laboratory equipment, techniques, and methodologies for technical assessments and data analysis purposes. Preference will be given to those with experience in GMP environments and technical data review specific to the pharmaceutical industry.

Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application.

Duties and Responsibilities

• Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
• Performs routine testing using analytical equipment including but not limited to HPLC, GC, KFC, Disso, etc.
• Conducts appearance testing, solution preparation, raw material sampling, and pH measurement
• Drafts stability tables, sets-up stability studies, logs-in samples and standards
• Cleans lab and glassware and disposes of analytical waste appropriately
• Participates in process improvement and other non-routine projects
• Enters clean spaces with appropriate PPE to collect various samples
• Is familiar with introductory analytical equipment (e.g., HPLC, GC-HS, TOC, FT-IR)
• Is familiar with raw materials testing requirements (compendial and client testing)
• Conducts peer review of routine testing at the discretion of the relevant supervisor
• Performs technical writing and reporting including but not limited to: incident reporting, laboratory investigations, CAPAs, SOPs, trend reports, risk assessments, etc.
• Performs hypothesis testing or investigative work for OOS results under management and SME guidance
• Demonstrates cross-functional support capabilities with other QC teams
• Responsibilities may increase in scope to align with company initiatives
• All other related duties as assigned

Required Skills and Abilities

• Hands-on lab experience in HPLC, CG-HS, TOC, FT-IR
• Hands-on lab experience with raw materials testing
• Strong verbal and written communication skills
• Demonstrated ability to collaborate and work in cross-functional teams
• Strong organizational skills and attention to detail
• Follows detailed written and oral instructions
• Strong time management skills with a proven ability to meet variable and competing deadlines
• Strong analytical and problem-solving skills
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
• Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
• Accepts feedback from a variety of sources and constructively manages conflict
• Ability to prioritize tasks and to keep leadership apprised of performance to timelines
• 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 related scientific discipline
• 3 years of hands-on laboratory experience required, cGMP preferred
• Minimum of 2 years of GMP experience required to be considered for Scientist II

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
• Adheres to predicable in-person attendance
• Motor skills required for basic laboratory operations