Scientist I

RXinsider LTD.; Morrisville (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Pace Analytical in Morrisville, NC is seeking a Scientist I to support analytical testing and method development for chemistry/biochemistry programs. You will oversee data analysis, interpretation and documentation to inform formulation decisions for early-stage drug products.

The role requires a Bachelor’s in chemistry/biochemistry (or related field) and 2–3 years of relevant experience with instruments such as HPLC, GC, LC-MS and FTIR.

Qualifications

• Bachelor’s degree in chemistry/biochemistry or related field.
• 2–3 years of relevant experience or equivalent.
• Experience with analytical instrumentation and data interpretation.

Responsibilities

• Provide or oversee analysis of materials, products and devices.
• Interpret analytical data to guide formulation decisions.
• Train others on tests, methods and instrumentation.
• Ensure activities comply with SOPs, GLP and GMP standards.

Skills

Chemistry expertise

Analytical thinking

Team collaboration

Communication skills

Problem solving

Education

BSc in chemistry/biochemistry

2–3 years experience

Tools

HPLC

GC

LC-MS

FTIR

Job description

Scientist I

SUMMARY

Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions.

ESSENTIAL FUNCTIONS

• Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.
  
• Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
  
• Provides training and guidance on analytical tests, methods, and instrumentation, as required.
  
• Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
  
• Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
  
• Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.
  
• Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, among others.
  
• Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products.
  
• Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
  
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
  
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
  

QUALIFICATIONS

Education and Experience

• Bachelor's degree in chemistry/biochemistry, or a closely related field.
  
• Two to three (2-3) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.
  

Required Knowledge and Skills

Required Knowledge

• Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development
  
• Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures.
  
• Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns.
  
• Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations.
  
• Understanding of broad testing tools, equipment, and calibration.
  
• Computer applications and systems related to the work.
  
• Principles and practices to serving as an effective project team member.
  
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
  
• Correct business English, including spelling, grammar, and punctuation.
  

Required Skills

• Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas.
  
• Overseeing and administering broad and varied chemistry/biochemistry/formulation functions.
  
• Ability to operate and train others in analytical instruments and manufacturing equipment.
  
• Training others in policies and procedures related to the work.
  
• Serving as a team member and the development and management of projects.
  
• Operating in a both a team and individual contributor environment.
  
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
  
• Preparing very complex to specialized functionals reports, correspondence, and other written materials.
  
• Using initiative and independent judgment within established department guidelines.
  
• Using tact, discretion, and prudence in working with those contacted during the work.
  
• Performing effective oral presentations to large and small groups across functional peers and the department.
  
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
  
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.