Analytical Chemist II

Mayne Pharma Group Limited Greenville , NC 27833

Posted 4 months ago

Position Overview

This position is responsible for independently performing routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements.

Key Responsibility Areas

  • Analytical Testing: With limited supervision, perform a broad array of primary and advanced analytical testing methods (wet and dry chemistry) in compliance with all cGMP and regulatory guidelines and ensure the highest standards for efficiency, right first-time measures, and quality standards

  • Data Interpretation and Problem-Solving: Use appropriate resources (e.g. software) to investigate and interpret data in support of recommendations for problem-solving related to methods, instruments and analytical techniques

  • Process Improvement: Identify and recommend opportunities for improved efficiencies, client service and teamwork within the analytical group

  • Quality: Ensure the integrity of data, quality of work, products and services as a first priority; complies or exceeds all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first-time measures

  • Safety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug products

  • Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements

  • Interpret data and make recommendations to management for improvement or potential concerns

  • Create report templates and/or enter data into established reports/templates or software-based systems

  • Under general supervision, author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team members

  • With guidance, propose applicable specifications based on data obtained in support of certain programs

  • Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation

  • Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations

  • Direct and assist in laboratory personnel training when required

  • Under general supervision, evaluate and validate methods of analysis for chemical entities and drug product formulations

  • Provide assistance with method development to ensure methods are robust and able to be validated

  • May serve as a technical liaison between functional groups such as Quality Assurance and metrology

  • Conduct peer review of routine and complex laboratory experiments for accuracy and provide guidance to junior team members to ensure future compliance

  • Maintain proficient knowledge in the use of Empower and other software-based systems; perform supervisory sign-off for electronic reports

Key Competencies/Requirements

  • Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others

  • Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems

  • Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services

  • Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates

  • Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas

  • Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people

  • Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled

  • Teamwork: Work well with others while providing support and assistance to team members to help accomplish objectives

  • Time Management: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity

Qualifications

  • Associate's degree in Biotechnology, Chemistry or equivalent science degree with 4 years of professional experience in pharmaceutical analytical chemistry

  • BS or BA degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with 3 years of professional experience in pharmaceutical analytical chemistry

  • Master's degree in a science-related field with 2 years of professional experience in pharmaceutical analytical chemistry

  • PhD in a science-related field with at least of 1 experience in pharmaceutical analytical chemistry

General Statement

Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.


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Analytical Chemist II

Mayne Pharma Group Limited