Analytical Scientist II

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make: As an Analytical Scientist II, you will be a key contributor to the development, validation, and transfer of analytical methods that ensure the quality and safety of our pharmaceutical products. Your expertise will directly support drug substance and product development, enabling reliable manufacturing processes and regulatory compliance. By delivering precise analytical data and innovative solutions, you will play a critical role in advancing our mission to manufacture more tomorrows for patients globally.

Responsibilities:

• Develop, optimize, and validate analytical test methods for pharmaceutical products, ensuring robustness and compliance with regulatory standards.
• Conduct routine and non-routine testing of raw materials, in-process samples, drug substances, and finished drug products to support formulation and process development.
• Analyze and report analytical data with high accuracy and scientific integrity, ensuring reliable results.
• Prepare and maintain technical documentation, including analytical method protocols, validation reports, technical reports, and SOPs.
• Troubleshoot analytical methods and instrumentation, proposing and implementing effective solutions to ensure operational efficiency.
• Facilitate the transfer of analytical methods to internal and external manufacturing and testing sites.
• Ensure compliance with cGMP, GLP, and company quality standards in all laboratory activities.
• Collaborate on cross-functional project teams and contribute to CMC documentation for regulatory submissions (IND, NDA, ANDA).
• Maintain accurate and timely laboratory records in accordance with company policies and regulatory requirements.
• Stay current with industry trends, technologies, and regulatory changes relevant to analytical sciences.
• Prioritize and manage personal workload to meet key objectives on time and within budget.
• Drive continuous improvement projects to enhance laboratory effectiveness and organization.
• Support the qualification of new analytical laboratory equipment.
• Apply creative problem-solving to address complex technical challenges.
  
  

Qualifications:

• Degree in scientific field: BS with 2+ years of experience, MS/PhD with 0+ years of experience.
• Experience in an FDA-regulated environment is a plus.
• Ability to adjust priorities in response to changing conditions.
• Experience with nasal spray drug products and devices is a plus.
• Strong attention to detail and scientific rigor.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in analytical instrumentation and techniques, including HPLC, GC, UV-Vis, FTIR, Karl Fischer, etc.
  
  

Physical Requirements:

• Employee is required to regularly use hands to handle materials and supplies.
• Employee is required to use computers for an extended period each day.
• Employee is required to effectively use communication by both telephone and electronic means.
• Employee is required to regularly stand and walk for extended periods.
• Employee must occasionally lift and/or move up to 25 pounds.
• Ability to use proper lifting techniques and be conscious of work area hazards.
• Employee is required to follow all site safety procedures.