Commercial Quality Control Chemist I

About the role

Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking a Commercial Quality Control Chemist to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications. Once the facility is underway, the Commercial Quality Control Chemist will be responsible for performing routine and non-routine analytical testing in support of commercial pharmaceutical manufacturing, including facility testing, finished product release, stability programs, in-process control testing, raw material testing, and other quality control activities as assigned.

Responsibilities

• Perform routine and non-routine analytical testing of commercial pharmaceutical products in accordance with approved analytical methods, specifications, SOPs, and laboratory procedures
• Execute facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned
• Operate applicable laboratory instrumentation and perform analytical techniques, including HPLC, GC, dissolution, UV-Vis, FTIR, and other technologies as qualified
• Prepare samples, standards, reagents, and solutions in accordance with approved procedures
• Accurately calculate, document, and report analytical results within established testing timelines
• Adhere to cGMP laboratory standards, Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory requirements
• Complete laboratory documentation ensuring accuracy and completeness
• Review analytical data and supporting documentation for accuracy, completeness, and compliance with approved procedures
• Maintain a clean, organized, and safe laboratory environment while following applicable safety and chemical hygiene procedures
• Participate in investigations related to laboratory incidents, deviations, OOS, OOT, and other unexpected analytical results
• Assist with root cause investigations and implementation of corrective and preventive actions (CAPAs) as assigned
• Support analytical method transfers and method verification activities as assigned
• Participate in laboratory training programs and maintain required training and qualification records
• Support laboratory continuous improvement initiatives to improve testing efficiency, accuracy, compliance, and right-first-time execution
• Assist in client inquiries, regulatory inspections, audits, and other QC activities as requested by QC management

Required Skills & Abilities

• Strong understanding of cGMP laboratory practices and applicable regulatory expectations
• Knowledge of Good Documentation Practices (GDocP) and data integrity principles
• Working knowledge of analytical chemistry principles, laboratory techniques, and pharmaceutical testing practices
• Demonstrated ability to accurately execute analytical methods and laboratory procedures
• Strong mathematical, analytical, and problem-solving skills
• Ability to interpret analytical results and identify atypical or unexpected data
• Excellent attention to detail and organizational skills
• Excellent time management skills with the ability to meet testing deadlines and commercial manufacturing schedules
• Ability to prioritize multiple tasks in a fast-paced laboratory environment
• Demonstrated ability to collaborate and work effectively in cross-functional teams
• Excellent verbal and written communication skills
• Ability to communicate analytical results, testing status, and laboratory concerns effectively
• Ability to follow written procedures and work independently with appropriate oversight
• Ability to accept feedback, adapt to changing priorities, and constructively manage conflict

Education & Experience

• Bachelor’s degree in a scientific discipline or related field, with 1‑2 years of hands‑on lab experience preferred; or
• Master’s degree in a scientific discipline or related field, with 1 year of hands‑on lab experience preferred
• Experience in pharmaceutical commercial QC testing preferred

Benefits

• Serán employees accrue over four weeks of paid time off annually
• 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 employees’ wellbeing, along with access to pet insurance