Senior Analytical Chemist, Core Sciences

Mayne Pharma Group Limited Greenville , NC 27833

Posted 3 months ago

Position Overview

This position performs route and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. This role provides laboratory troubleshooting for a team to assist in the successful and timely execution of laboratory analyses.

Key Responsibility Areas

  • Analytical Testing: Without supervision, perform a broad array of primary 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

  • Client Service: Serve as the secondary interface with internal/external client organizations to ensure timely and complete reporting, problem-solving and the highest level of service and responsiveness

  • Data Interpretation and Problem-solving: Perform analytical data/report review as well as investigate and interpret data in support of conclusions for routine problem-solving related to methods, instruments and analytical techniques

  • 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

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

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

  • 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

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

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

  • Review routine laboratory experiments for accuracy and provide guidance to junior team members to ensure future compliance

  • Identify and recommend opportunities for improved efficiencies, internal/external client service and teamwork within the analytical group

  • Serve as a point of contact for laboratory testing support and provide updates to laboratory supervision and/or client

  • With supervision, support the scheduling and planning of internal/external client project work to ensure the highest levels of efficiency and quality standards are met

  • Support the development of a climate of quality within the teams by driving and monitoring quality standards within the team

  • Become resident expert in the use of Empower (perform supervisory sign-off for electronic reports) and other software-based systems

  • Serve as a method troubleshooting resource to identify and document critical factors that affect method performance and assist peers in resolving method issues in a timely, cost-effective manner

  • Independently perform method evaluation/development/validation and troubleshooting instruments and improvement of processes

  • Assist laboratory management with the preparation and execution of laboratory investigations/deviations and CAPA within the electronic quality system (eQMS)

  • Mentor and train new laboratory team members

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 7 years of professional experience in pharmaceutical analytical chemistry

  • BS or BA degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with 6 years of professional experience in pharmaceutical analytical chemistry

  • Master's degree in a science-related field with 5 years of professional experience in pharmaceutical analytical chemistry

  • PhD in a science-related field with 4 years of relevant experience in pharmaceutical analytical chemistry

Physical Requirements

  • Majority of work day is performed while standing, walking, lifting, pulling, pushing

  • Requires the use of hands for simple grasping and fine manipulations

  • Requires the ability to stand for extended periods of time

  • Some exposure to hazardous chemical and other active chemical ingredients

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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Senior Analytical Chemist, Core Sciences

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