Serán BioScience · 1 day ago
Quality Control Scientist I/II, In-Process Control
Bend, OR
Full-time
Onsite
Mid, Senior Level
3+ years expSerán BioScience is looking for a scientist with laboratory experience to support manufacturing of pharmaceutical drug products within their In-Process Control group. The role involves testing raw materials and production equipment to ensure the highest quality product in GMP environments.
Biotechnology
No H1B
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
Qualification
Required
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
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
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
Preferred
Experience in GMP environments and technical data review specific to the pharmaceutical industry
Benefits
Generous PTO accrual
Low-cost health benefits
5% 401(k) contribution that does not require an employee match or vesting
Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period
Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions
Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage
An Employee Assistance Program provides support for all things related to our employees’ wellbeing
Access to pet insurance
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase