Commercial QC Chemist II - Pharma Testing & Start-up

Serán BioScience; Bend (OR); Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Retirement plan

Health plans

Life and long-term disability

Employee Assistance Program

Pet insurance

Descripción de la vacante

Serán BioScience is expanding its Bend, Oregon campus with a new GMP manufacturing facility and seeks an experienced Commercial Quality Control Chemist II to contribute to the start-up and ongoing commercial testing activities. The role involves testing, method implementation, equipment qualification, data integrity, and investigations in a fast-paced environment.

The position emphasizes regulatory compliance, product quality, client interactions, and continuous improvement, with opportunities

Formación

• Demonstrates intermediate expertise with analytical equipment and techniques used in commercial pharmaceutical testing.
• Strong understanding of cGMP, GDocP, data integrity and regulatory expectations.
• Able to execute analytical methods and interpret data accurately.
• Excellent verbal and written communication, teamwork and mentoring abilities.
• Experience with OOS/OOT investigations and deviations is preferred.

Responsabilidades

• Perform routine and non-routine QC testing across finished product, in-process and materials.
• Lead and support investigations, deviations, and CAPAs with QC management.
• Review technical data, calculations, and documentation for accuracy and compliance.
• Transfer, verify and optimize analytical methods for commercial products.
• Coordinate daily lab workflow, testing priorities and resource needs.
• Interface with clients and internal stakeholders on technical matters.
• Assist with SOP development, revisions and technical reviews.
• Provide training and mentoring for QC staff and junior chemists.

Conocimientos

HPLC

GC

Dissolution

Karl Fischer

XRPD

mDSC

UV-Vis

FTIR

GDocP

data integrity

OOS/OOT investigations

analytical method execution

communication

mentoring

Microsoft Office

LIMS familiarity

Empower

Educación

Bachelor's degree in Chemistry/Pharmaceutical Sciences/Biochemistry

Master's degree in Chemistry/Pharmaceutical Sciences/Biochemistry

1 year GMP laboratory experience

2 years hands-on lab experience (BS)

Experience in pharmaceutical QC testing

Herramientas

LIMS

Empower

Electronic laboratory systems

SOPs and regulatory documentation systems

Descripción del empleo

Serán BioScience is expanding its Bend, Oregon campus with a new GMP manufacturing facility and seeks an experienced Commercial Quality Control Chemist II to contribute to the start-up and ongoing commercial testing activities. The role involves testing, method implementation, equipment qualification, data integrity, and investigations in a fast-paced environment.

The position emphasizes regulatory compliance, product quality, client interactions, and continuous improvement, with opportunities