Analytical R&D Supervisor

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

The Bend, Oregon site consists of approximately 100 highly motivated employees focused on contract early phase clinical drug product formulation development and manufacture. Bend, Oregon is a beautiful community of around 115,000 people commonly known as ‘the outdoor playground of the West’.

How will you make an impact?

The Analytical R&D Supervisor will lead a midsized team of analytical scientists in supporting early phase pharmaceuticals in a fast-paced and flexible contract development and manufacturing organization (CDMO). Supervising responsibilities include managing team’s performance to ensure client deliverables are met, reviewing analytical data, validation protocols, methods and reports, providing technical guidance, and implementing new analytical technologies and experimental design.

What will you do?

• Reviewing and approving protocols, reports and analytical methods for drug products with the following techniques: HPLC assay and impurities, dissolution, water content, residual solvent by GC and other analytical techniques
• Reviewing analytical data and presentation slides, providing technical guidance both internally and externally
• Hiring, onboarding and supervising varying levels of analytical scientists including facilitating positive team member interaction and conflict management
• Training and performance management to drive a high performing team and individual team member’s career growth
• Scheduling projects, aligning priorities, and providing clear direction
• Interacting professionally with colleagues, emulating role model leadership and collaborating with multiple departments to ensure client deliverables are met
• Establishing and updating SOPs and best practices. Working effectively with senior management to set expectations and ensure cross-training of key roles
• Escalating project issues and risks to senior management in a timely manner and helping drive resolutions
• Researching and implementing new methodologies, instruments and processes with senior management support and approval
• Driving process improvements
• Performing all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and safety guidelines. Maintaining the necessary compliance status required by company and facility standards

Education and Experience

• Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science. Equivalent combinations of education, training, and relevant work experience may be considered

• At least 1 years industry experience with leading or supervising a team
• At least 5 years working in a laboratory environment. GMP experience is preferred
• Extensive experience with analytical early development/techniques or method development and validation techniques
• Experience with small molecules and oral solid doses
• Experience with client communications

Knowledge, Skills, Abilities

• Excellent people managing skills
• Excellent knowledge of method development and validation
• Excellent understanding of ICH and other regulatory guidelines
• Flexible, organized, ability to prioritize, and strong negotiating skills
• Knowledge of Good Manufacturing Practices and data integrity (ALCOA)
• Excellent critical and logical thinking skills
• Effective written, interpersonal, and presentation skills
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)

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