Quality Control Chemist
Bend, OR
Do you:
- Like finding new and better ways to do things?
- Want to help develop medicines to make patients’ lives better?
- Desire to learn and grow?
- Nerd out on science & technology?
- Value people and working in a collaborative team?
- Desire to be audacious and entrepreneurial?
- Value safety and leading by example?
- Care about doing the right thing?
At Bend Bioscience, we are looking for colleagues with: SCIENTIFIC CURIOSITY, HONESTY, HUMOR, CONFIDENCE, HUMILITY, TRUSTWORTHINESS, RESPECT FOR CO-WORKERS, and the DESIRE TO MAKE A DIFFERENCE AND HELP PATIENTS.
Job Description:
Bend Bioscience is focused on research, development, and clinical production of non-sterile drug delivery technologies, drug products, and intermediates for the pharmaceutical industry. In this role, you will perform analytical testing and collaborate with QC manager to establish workflows/systems for a new QC laboratory.
The QC Chemist will be responsible to progress programs collaboratively with multi-disciplinary teams by:
- Developing, authoring, and implementing QC workflows (e.g. sample management, stability program, inventory tracking for columns, reagents, reference standards, equipment management, waste management, training) by generating Standard Operating Procedures (SOPs) and Work Instructions.
- Generating and reviewing protocols for equipment and method qualification (IQ/OQ/PQ).
- Author and review technical documents such as methods, specifications, validation protocols and reports, transfer protocols and reports, SOPs, compendia requirements, ICH and FDA guidelines.
- Review/interpret analytical results and make recommendations.
- Mentor junior staff and provide training.
- Maintain and troubleshoot instrumentation.
- Author investigations (Deviations and OOS), Corrective Actions, Change Controls.
- Support continuous improvement initiatives.
- Maintain laboratory workspace to ensure it is audit ready.
- Collaborate with multi-disciplinary team to ensure project and team objectives are met.
- Perform GMP testing for the release of raw materials, intermediates, and final product and document all test results with adherence to ALCOA.
- May interact with customers and auditors.
Characteristics:
- Collaborative
- Commitment to GMP compliance and safety
- Strong interpersonal skills
- Proven ability to work independently, efficiently, and plan successfully
- Strong analytical skills and attention to detail
- Excellent oral and written communication
- Accountable and responsible
Experience and Educational Requirements:
- BS/BA in chemistry, pharmaceuticals, or related field with minimum 5 years of experience in pharmaceutical industry with a focus on analytical chemistry.
- HPLC and wet chemistry experience required.