Senior Analytical Chemist, Quality Control

Position Overview

This position performs routine 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:  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
• Client Service:  Support and sometimes participate in the direct interaction with client organizations to assure timely and complete reporting, problem-solving and the highest level of service and responsiveness
• Data Integrity:  Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
• Data Interpretation and Problem-Solving:  Use appropriate resources (e.g. software) toinvestigate 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 quality of work, products and services as a first priority; comply with or exceed 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

• 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

• Analytical Acumen: Skilled in the interpretation and application of data in problem-solving, decision-making, account planning, and activity prioritization.
• Decision Quality: Considers all relevant factors (analysis, wisdom, experience and judgment) and uses appropriate decision-making criteria and principles.
• Equipment Operation: Is skilled in the use and trouble-shooting of key equipment important in the delivery of the job.
• Problem Solving: Build a logical approach to address problems or opportunities or manage the situation at hand by drawing on one’s knowledge and experience base and calling on other references and resources as necessary.
• Quality: Prioritizes and delivers highest levels of quality in work and interactions with customers and team members.
• Self-Awareness: Self-Aware, open to coaching and self-improvement, agile and decisive in decisions. Is highly effective socially and interpersonally- adept at interpreting social and emotional cures and adapting approach and messaging accordingly.
• Training Others: Carefully and fully articulates methods and approaches in a way that is understood by using delivery mechanisms that meet the needs of the learner.
• Written Communication: Conveys ideas and facts in writing in a way that will be understood by composing in a clear, direct, concise and complete manner.

• Associate 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 ability community effectively using speech, vision and hearing
• 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

Equal Employment Opportunity and Employment Eligibility 

Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Mayne Pharma is an E-Verify employer.