Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

Location/Division Specific Information

The Bend, Oregon Thermo Fisher Scientific site consists of approximately 100 highly motivated employees focused on contract early phase clinical drug product formulation development and manufacture. Primarily focused in small molecule, oral solid dosages, and solubility enhancement techniques. Bend is a beautiful community of around 105,000 people commonly known as ‘the outdoor playground of the West’ because of the myriad of available outdoor activities.

How will you make an impact?

An Analytical Development Manager will be responsible for various analytical departments, examples include early development formulation analytics, method development, and quality control. They will provide strong technical direction to meet client needs, spearhead innovation, ensure compliance with all regulatory requirements, manage team performance, communicate effectively with cross-functional departments, and implement strategies in line with Sr. Management expectations.  

What will you do?           

Lead, mentor, and build a hard-working team of supervisors and scientist.Coordinate team efforts to ensure client objectives and project timelines are met.Conduct performance evaluations, facilitate positive team member interactions, resolve conflicts, drive solutions, and lead change management initiatives.Develop and implement department goals and objectives, maintain budgets, provide clear direction, and maintain metrics.Emulate role model leadership and collaborate with multiple departments.Ensure all actives align with site and regulatory requirements.Review and approve technical documents, stability protocols, reports, COAs, methods, specifications, etc.Review CAPAs, change controls, SOPs, deviations, Out of Specifications, training materials, and other documents as needed.Provide leadership in client discussions and audits.Stay current with industry standards and technology advancements to ensure compliance and continuous improvements.Develop and implement process improvements to gain efficiencies.Ensures laboratory safety and cleanliness is maintained.Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.

How will you get here?

Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.At least 8 years working in a regulated laboratory environment. Pharmaceutical industry is preferred.At least 5 years of leadership experience, building and managing teams.Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

In-depth knowledge of Good Manufacturing Practices, FDA regulations, ICH Guidance, and data integrity (ALCOA+)Strong leadership, mentorship, and team management skills.Excellent analytical and problem-solving skills.Excellent communication skills, both verbal and written.Detailed oriented with strong organization sills.Ability to prioritize tasks and manage multiple project simultaneously.Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint)

Physical Requirements:

Typically requires standing or sitting for a shift.Occasionally requires lifting of up to 20 pounds.Present and available on-site.