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

Serán BioScience; Bend (OR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

PTO accrual

Retirement plan (5% 401k)

Health plans

Life and disability coverage

Employee assistance program

Job summary

Serán BioScience in Bend, Oregon seeks a scientist with laboratory experience to support manufacturing in In-Process Control within GMP environments. You will test raw materials and production equipment, review data, and contribute to technical investigations to ensure high-quality drug products.

Preferred candidates have cGMP experience and strong written and verbal communication. The role emphasizes collaboration with QC teams, data analysis, and involvement in process improvements in a

Qualifications

• Bachelor's degree in a related scientific discipline is required.
• 3 years of hands-on laboratory experience; cGMP experience preferred.
• Minimum 2 years of GMP experience to be considered for Scientist II.

Responsibilities

• Adheres to SOPs, cGMPs, Quality Manual, and company policies.
• Performs routine testing using analytical equipment including HPLC, GC, TOC, FT-IR.
• Conducts appearance testing, solution preparation, raw material sampling, and pH measurement.
• Drafts stability tables, sets up stability studies, logs samples and standards.
• Cleans lab and glassware and disposes of analytical waste appropriately.
• Performs technical writing and reporting including incident reporting and investigations.
• Supports cross-functional QC teams and participates in process improvement initiatives.

Skills

HPLC

GC-HS

TOC

FT-IR

Raw materials testing

Cross-functional collaboration

Written communication

Education

Bachelor's degree in related scientific discipline

Tools

Microsoft Office Suite

Job description

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 testingusing analytical equipmentincluding but not limited to HPLC, GC,KFC,Disso,etc.
• Conducts appearance testing, solution preparation, raw material sampling, and pH measurement
• Draftsstability tables, sets-up stability studies,logs-insamplesand standards
• Cleans lab and glassware anddisposesof 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)
• Conductspeer review ofroutine testingat the discretion of the relevantsupervisor
• Performstechnical writing and reporting including but not limitedto:incident reporting, laboratory investigations, CAPAs,SOPs,trend reports,risk assessments,etc.
• Performshypothesis testingor investigative work for OOS resultsunder management and SME guidance
• Demonstratescross-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 andmaintainsproductive relationships with coworkers, clients, and other contacts outside the Company
• Multitasks and adjusts priorities in a fast-paced environment, whilemaintainingfocus 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

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary

• 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 our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701