Manager, Analytical Development + Quality Control
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, TRUSTWORHTYNESS, 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 lead a team of quality control scientists to develop and progress analytical methods and conduct release testing and stability studies on clinical materials. The AD and QC manager will work collaboratively with product development and R&D to progress client programs and innovate on new analytical techniques.
The manager of Analytical Development and Quality Control will be responsible to develop methods and progress client programs by:
- Managing and building the quality control team
- Coordinating day-to-day activities and ensuring the required testing is accomplished
- Defining and authoring the quality control lab procedures, policies, and workflows
- Leading the implementation and maintenance of sample management, stability program, and general laboratory operational systems in accordance with GMPs
- Collaborating with supply chain, project management, quality assurance, product development, and R&D to ensure client and project deadlines and objectives are met
- Supporting regulatory and third-party inspections and providing technical support for troubleshooting and investigations
- Understanding and guiding phase appropriate specifications in collaboration with clients
- Researching, developing, validating, and implementing test methods across a wide variety of instruments and techniques
- Performing routine analytical GMP testing for the release of raw materials, intermediates, and final products and documenting test results with adherence to GMP guidelines
- Performing R&D and GMP testing and documenting results
- Performing R&D and GMP review of analytical data
- Ensuring effective implementation of instrument and equipment qualification, calibration, and maintenance for analytical and chemistry supporting assets
- Ensuring that a high standard of knowledge, performance, training, and safety are developed, and maintained by all employees
- Staying current with new technologies, research in progress, tests, and any changes to agency guidelines and requirements
- Making recommendations regarding new equipment, capabilities, or capacity needed and preparing a budget and justification
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
- Leadership experience with a desire to enable growth
- Excellent oral and written communication
- Accountable and responsible
- Experience and Educational Requirements:
- BS/ MS/ PhD in Biology, Biochemistry, Chemistry or related field with 5+ years of industry experience and 2+ years of supervisory/ management experience
- In-depth knowledge of how to develop, optimize, validate/qualify, and transfer analytical methods
- Experienced and understanding of working in a GMP environment and adherence to compliance
- Experienced in analytical chemistry techniques and methods as they relate to the analysis of small molecule drug substance and drug product (HPLC, cleaning method, dissolution, Karl Fischer, IR, UV-Vis, and pH)