Scientist I

Role overview

This position involves hands-on laboratory and manufacturing support work in a regulated pharmaceutical environment. The scientist will carry out both routine and advanced testing, help with method and process activities, document results accurately, and contribute to projects that support quality and operational goals.

Core laboratory duties

• Perform standard and advanced lab work with limited oversight, including testing raw materials, in-process samples, and finished drug products for quality, purity, safety, strength, and identity using approved methods.
• Support manufacturing of drug products and work within cGMP, EH&S, and other applicable internal, FDA, and regulatory requirements.
• Independently set up equipment, run instruments, and troubleshoot analytical methods and instrumentation.
• Investigate out-of-specification and out-of-trend outcomes and recommend appropriate corrective actions.
• Carry out approved method transfer activities and assist in developing and validating cleaning validation methods.
• Record all work accurately in laboratory notebooks and other required documentation.
• Review data, spot trends, and complete basic statistical calculations.

Documentation and project support

• Draft protocols, reports, methods, standard operating procedures, and submission-related documents under supervision.
• Take part in project work and help keep deliverables aligned with team timelines and objectives.
• Lead smaller project tasks independently, with some supervision as needed.
• Support the assessment and rollout of new technologies.
• Train other scientists when required.

Collaboration and compliance

• Communicate clearly with teammates and internal or external stakeholders.
• Work effectively across functions and build strong working relationships.
• Follow SOPs, corporate safety rules, and company policies at all times.

Qualifications

The role requires one of the following backgrounds: a PhD in analytical chemistry or a closely related field with 0 to 2 years of experience, an MS in Chemistry with 3 to 5 years of experience, or a BS degree with at least 7 years of analytical research experience in the pharmaceutical or a related industry.

Candidates should have broad knowledge of analytical chemistry tools and techniques such as HPLC, GC, UV, FTIR, and related technologies, or a basic understanding of the development and manufacturing of MDI, DPI, and nasal products.

Strong knowledge of FDA cGMP requirements, USP methodologies, and ICH guidelines is needed, along with excellent written and spoken English communication skills.

Physical requirements

Work is generally performed in a laboratory setting and may involve standing, walking, sitting, using hands and fingers, reaching with arms, and speaking and hearing. In some situations, bending, kneeling, crouching, stooping, or crawling may also be necessary. The role may require lifting up to 15 pounds occasionally.

Competencies

• Strategic thinking and adaptability
• Innovation and creativity
• Customer focus
• Talent development
• Results-driven mindset
• Process discipline and excellence
• Team collaboration
• Stakeholder coordination