Lead Analytical Scientist

1 week ago

Denville, New Jersey, United States Ingenus Full time
Job Overview

Position Objective

This role is designed for a highly skilled individual who will undertake sophisticated and essential analytical evaluations alongside standard chemical assessments on in-process, finished products, stability, and raw material samples. The scientist is expected to operate autonomously and must possess the capability to develop high-quality, efficient, and stability-indicating HPLC, UPLC, and GC methodologies while executing method validation.

Key Responsibilities

  • Perform analytical evaluations in accordance with approved testing protocols to ensure pharmaceutical products meet established specifications. Conduct analytical assessments on R&D batches of various dosage forms, including parentals, topicals, transdermal, solid oral, and nasal products, along with associated stability studies, and generate analytical documentation.
  • Recommend product characterization criteria in alignment with USP and FDA standards.
  • Collaborate closely with the FRD team to provide timely assistance.
  • Develop analytical methods for assay, related substances, and dissolution consistent with formulation requirements and document method development findings.
  • Prepare and review protocols for method validation, verification, and transfer.
  • Conduct method verification and transfer of validated analytical techniques as necessary.
  • Draft and review specifications, testing methodologies, and results as required.
  • Maintain accurate laboratory records (adhering to GDP/GLP/cGMP) and prepare ARD/QC reports when applicable.
  • Respond promptly to all data evaluations.
  • Exhibit superior troubleshooting skills; resolve technical issues related to instruments, testing methods, and products.
  • Assist management in addressing audit findings in a timely manner.
  • Adhere to all relevant standard operating procedures (SOPs).
  • Comply with all laboratory safety and housekeeping protocols.
  • Perform additional responsibilities as assigned.

Essential Knowledge, Skills, and Abilities

  • Extensive knowledge in the pharmaceutical sector with advanced instrumentation expertise, including HPLC, UV-Vis, UPLC, ICP/MS, and USP dissolution apparatus 1, 2, 3, 4, and 7.
  • Proven understanding of LC/MS and GC/MS, XRD, TGA, and DSC.
  • Ability to input data with precision.
  • Capability to manage multiple tasks effectively.
  • Skill in facilitating the resolution of client concerns.
  • Proficiency in Microsoft applications.
  • Exceptional interpersonal skills and the ability to cultivate and maintain effective working relationships with both internal and external stakeholders.

Education and Experience Requirements

  • Bachelor's degree in chemistry or a related discipline with 10+ years of experience.
  • Master's degree in chemistry or a related discipline with 8+ years of experience.
  • Doctorate in chemistry or a related discipline with 5+ years of experience.
  • Experience is expected to be in analytical laboratories, preferably within the pharmaceutical industry, with a focus on injectable dosage forms being advantageous.
  • Management recommendation is required.

Planning and Accountability Skills

  • Ability to prioritize and organize daily tasks to meet project deadlines and manage multiple projects.
  • Self-directed and independent.

Communication Proficiency

  • Excellent verbal and written communication skills.
  • Ability to work collaboratively in a team environment and facilitate teamwork.
  • Capability to promote communication with other departments.

Physical Requirements

This position necessitates regular use of a computer and laboratory work involving chemicals.

Work Environment

General office and laboratory setting.

Ingenus Pharmaceuticals LLC. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.

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