Sr. Manager of Analytical Research and Development

Tulex Pharmaceuticals Inc.; Cranbury Township (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

Tulex Pharmaceuticals Inc. is seeking a Sr. Manager of Analytical Research and Development in New Jersey. You will lead the analytical R&D team, drive method development and validation, plus support material and product characterization, formulation development, and data interpretation.

The role requires strong knowledge of HPLC/UPLC, GC, GC/MS, LC-MS/MS, and QBD, with solid cGMP experience and excellent communication. A PhD is preferred, and prior leadership is essential.

Qualifications

• PhD or MS in Analytical Chemistry or related field; PhD preferred.
• Minimum 4 years leading analytical R&D teams in pharma.
• Minimum 6 years method development for small molecule APIs and products.
• Extensive experience operating and interpreting data from HPLC, UPLC, dissolution, GC; LC-MS/MS a plus.
• Strong chemistry knowledge and QBD method development expertise.
• Experience authoring Module 3 Analytical CMC documents.
• Excellent time management and fast-paced environment adaptability.
• Strong problem-solving and communication skills.

Responsibilities

• Lead analytical R&D team and manage method development activities.
• Oversee phase-appropriate method validation and material characterization.
• Support formulation development and analytical data interpretation.
• Troubleshoot investigations and train staff; ensure good documentation practice.
• Ensure compliance with pharmaceutical regulations and cGMP.

Skills

Team leadership

Problem solving

Effective communication

Time management

Adaptability

Strong documentation practices

cGMP knowledge

Education

PhD in Analytical Chemistry or related field

MS in Analytical/Chemistry (PhD preferred)

Tools

HPLC/UPLC

Dissolution

GC

LC-MS/MS

GC/MS

Job description

Sr. Manager of Analytical Research and Development

You will be responsible to lead and manage an analytical research and development team.The main responsibilities include but not limited to managing the activities of analytical method development, phase appropriate method validation, characterization of raw material, drug substance and drug product, formulation development support, analytical data interpretation, trouble shooting and investigation and employee training.

Qualifications

• Ph.D. degree or Master degree in Analytical Chemistry, Organic Chemistry or Chemistry related fields. Ph.D. is preferred.
• At least 4 years of managing analytical research and development team experiences in pharmaceutical industry.
• At least 6 years of method development experiences in small molecule drug substances and drug products.
• Extensive experiences in operating and data interpretation of HPLC, UPLC, Dissolution, and GC.Experience in LC/MS/MS and GC/MS is a plus.
• Solid knowledge in Chemistry
• Expertise in analytical method development by QBD
• Module 3 Analytical CMC documents authoring experience
• Must have good time managing skill, self-directing and adaptability to fast pace working environment.
• Quick thinking and strong problem-solving capabilities
• Deep understanding of Pharmaceutical and cGMP regulation
• Excellent work attitude/ethics
• Ability to follow Good Documentation Practice for notebook recording, protocol design and report writing
• Must be a good team player
• Excellent oral and written communication