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

Serán BioScience • Bend, OR

5d • Onsite

About The Position

Serán BioScience is seeking a scientist with laboratory experience to support pharmaceutical drug product manufacturing within its In-Process Control group. As part of the Quality Control department, the scientist works with other scientists and operators to help ensure product quality by testing raw materials and production equipment in GMP manufacturing and laboratory environments. The role uses specialized laboratory equipment, techniques, and methodologies for technical assessments and data analysis. Experience in GMP environments and pharmaceutical technical data review is preferred.

The position includes routine analytical testing, sampling, sample and stability-study management, laboratory upkeep, technical documentation, and support for investigations and process-improvement projects. The employee may enter clean spaces with appropriate PPE to collect samples, conduct peer review of routine testing at a supervisor’s discretion, and provide cross-functional support to other QC teams. Responsibilities may expand in line with company initiatives.

The role requires a related scientific bachelor’s degree and at least three years of hands-on laboratory experience. At least two years of GMP experience is required for consideration at the Scientist II level. This is an in-person role in the laboratory and manufacturing environment, with physical requirements including extended periods sitting or standing, occasional lifting up to 25 pounds, and motor skills for basic laboratory operations.

Requirements

• Bachelor’s degree in a related scientific discipline.
• At least 3 years of hands-on laboratory experience.
• Hands-on laboratory experience with HPLC, CG-HS, TOC, and FT-IR.
• Hands-on laboratory experience with raw materials testing.
• Strong verbal and written communication skills.
• Ability to collaborate and work in cross-functional teams.
• Strong organizational skills and attention to detail.
• Ability to follow detailed written and oral instructions.
• Strong time management skills and ability to meet variable and competing deadlines.
• Strong analytical and problem-solving skills.
• Ability to communicate effectively and maintain productive relationships with coworkers, clients, and external contacts.
• Ability to multitask and adjust priorities in a fast-paced environment while maintaining focus and managing disruptions or unexpected needs.
• Ability to accept feedback from a variety of sources and constructively manage conflict.
• Ability to prioritize tasks and keep leadership apprised of performance against timelines.
• Ability to function in a high-paced and sometimes stressful environment.
• Proficiency with Microsoft Office Suite or related software.
• Adherence to predictable in-person attendance.
• Ability to lift up to 25 pounds at times and perform motor skills needed for basic laboratory operations.

Nice To Haves

• GMP experience is preferred generally; at least 2 years of GMP experience is required for consideration at the Scientist II level.
• Experience with technical data review specific to the pharmaceutical industry.
• Familiarity with introductory analytical equipment such as HPLC, GC-HS, TOC, and FT-IR.
• Familiarity with raw material testing requirements, including compendial and client testing.

Responsibilities

• Adhere to Standard Operating Procedures, cGMPs, the Quality Manual, and company policies.
• Perform routine testing using analytical equipment, including HPLC, GC, KFC, and Disso.
• Conduct appearance testing, prepare solutions, sample raw materials, and measure pH.
• Draft stability tables, set up stability studies, and log in samples and standards.
• Clean the laboratory and glassware and dispose of analytical waste appropriately.
• Participate in process improvement and other non-routine projects.
• Enter clean spaces with appropriate PPE to collect samples.
• Conduct peer review of routine testing at the discretion of the relevant supervisor.
• Perform technical writing and reporting, including incident reports, laboratory investigations, CAPAs, SOPs, trend reports, and risk assessments.
• Perform hypothesis testing or investigative work for OOS results under management and subject matter expert guidance.
• Provide cross-functional support to other QC teams.
• Perform other related duties as assigned.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer retirement account contributions begin after 90 days and do not require an employee match or vesting period; the posting also describes a 5% 401(k) contribution.
• Various health plans with minimal employee contributions.
• Basic life insurance and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level