Corden Pharma - A Full-Service CDMO
Principal Analytical Chemist
Corden Pharma - A Full-Service CDMO, Boulder, Colorado, United States, 80301
Overview
Performs and leads analytical research and development activities for the purpose of designing/improving a manufacturing process or technology as well as producing clinical trial batches by performing the following duties. Essential Duties And Responsibilities
Leads large and/or multiple teams to accomplish technology transfers and/or development projects. Applies analytical and organic chemistry skills to the improvement of processes. Participates in the budget process of research projects and/or technology transfers. Initiates and executes the development of new and innovative analytical chemistry and methodology. Provides written analytical procedures and reports to support manufacturing and regulatory needs. Lead analytical technology transfer activities associated with a method or project. Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden Stability Program. Develops and applies analytical techniques at a process scale (e.g., process chromatography). Responsible for the analytical sections of process procedures. Develops key technologies and transfer strategies that function well in a manufacturing environment. Plans and formulates aspects of analytical research and development proposals such as objectives or purpose of project, applications that can be utilized from findings, cost of project, equipment, and human resource requirements. Identifies analysis points and develops methods, and procedures for monitoring projects. Devises and completes method validation studies. Practices excellence in verbal and written communication skills to update management and clients on the current statuses of each project. Maintains documentation such as analysis data and procedures and progress reports in accordance with GLP and company policies. Submits patents, presents at scientific conferences and company-wide forums, and publishes in scientific journals. Investigates new analytical technologies and equipment with the aim of practical utilization in new and existing manufacturing processes. Develops expertise in key advanced analytical techniques. Analyzes batches of drug substance intermediates and raw materials to be used in clinical registration program. Proposes analytical specifications for control of raw materials, intermediates, in-process testing, and drug substances for in-house use and regulatory filings. Participates in manufacturing site activities, such as troubleshooting and analytical problem solving. Develops thorough understanding of QEH&S principles and regulatory affairs. Impacts analytical process development in at least two areas. Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste. Leadership & Budget Responsibilities
Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. Leads team in the development, troubleshooting, transfer, and improvement of chemical processes. Expected to work interactively and collaboratively in a project team environment both internally and with clients. May directly lead 1 – 5 employees. Carries out leadership responsibilities in accordance with Corden policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraise performance, reward and discipline employees; address complaints and resolve problems. Safety & Environmental Responsibilities
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience. Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education And/or Experience
Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience. Language Skills
Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, clients, public groups, and/or boards of directors. Mathematical Skills
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply statistical concepts such as significant figures, frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables. Certificates, Licenses, Registrations
Domestic and international travel required. Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is regularly required to talk or hear, stand, walk, and sit. The employee may need to work with hands, reach above shoulder height, climb or balance, stoop, kneel, crouch, or crawl, and may occasionally lift and/or move up to 50 pounds. Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to toxic and/or caustic chemicals and high potent compounds is possible; risk of electrical shock; normal noise level is moderate. Core Competencies
Scientific leadership in analytical chemistry for API synthesis Presentation and persuasion skills Training and facilitation skills Developed written and verbal communication skills Complete understanding of cGMP and GLP requirements Salary
Actual pay will be based on your skills and experience. Benefits
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service Accident Plan Critical Illness Insurance Dental Insurance Disability Insurance Employee Assistance Program Flexible Spending Account Health Insurance PPO/HSA Hospital Indemnity Plan ID Theft Protection Life Insurance Paid Maternity/Paternity Leave Tuition Reimbursement Wellness Program Vacation – Three Weeks 1st Year Vision Insurance This post will expire on 10/31/2025. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Corden Pharma - A Full-Service CDMO by 2x Sign in to set job alerts for “Analytical Chemist” roles.
Boulder, CO 92,000 - 110,000 and related geographic listings are included for context.
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Performs and leads analytical research and development activities for the purpose of designing/improving a manufacturing process or technology as well as producing clinical trial batches by performing the following duties. Essential Duties And Responsibilities
Leads large and/or multiple teams to accomplish technology transfers and/or development projects. Applies analytical and organic chemistry skills to the improvement of processes. Participates in the budget process of research projects and/or technology transfers. Initiates and executes the development of new and innovative analytical chemistry and methodology. Provides written analytical procedures and reports to support manufacturing and regulatory needs. Lead analytical technology transfer activities associated with a method or project. Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden Stability Program. Develops and applies analytical techniques at a process scale (e.g., process chromatography). Responsible for the analytical sections of process procedures. Develops key technologies and transfer strategies that function well in a manufacturing environment. Plans and formulates aspects of analytical research and development proposals such as objectives or purpose of project, applications that can be utilized from findings, cost of project, equipment, and human resource requirements. Identifies analysis points and develops methods, and procedures for monitoring projects. Devises and completes method validation studies. Practices excellence in verbal and written communication skills to update management and clients on the current statuses of each project. Maintains documentation such as analysis data and procedures and progress reports in accordance with GLP and company policies. Submits patents, presents at scientific conferences and company-wide forums, and publishes in scientific journals. Investigates new analytical technologies and equipment with the aim of practical utilization in new and existing manufacturing processes. Develops expertise in key advanced analytical techniques. Analyzes batches of drug substance intermediates and raw materials to be used in clinical registration program. Proposes analytical specifications for control of raw materials, intermediates, in-process testing, and drug substances for in-house use and regulatory filings. Participates in manufacturing site activities, such as troubleshooting and analytical problem solving. Develops thorough understanding of QEH&S principles and regulatory affairs. Impacts analytical process development in at least two areas. Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste. Leadership & Budget Responsibilities
Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. Leads team in the development, troubleshooting, transfer, and improvement of chemical processes. Expected to work interactively and collaboratively in a project team environment both internally and with clients. May directly lead 1 – 5 employees. Carries out leadership responsibilities in accordance with Corden policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraise performance, reward and discipline employees; address complaints and resolve problems. Safety & Environmental Responsibilities
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience. Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education And/or Experience
Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience. Language Skills
Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, clients, public groups, and/or boards of directors. Mathematical Skills
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply statistical concepts such as significant figures, frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables. Certificates, Licenses, Registrations
Domestic and international travel required. Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is regularly required to talk or hear, stand, walk, and sit. The employee may need to work with hands, reach above shoulder height, climb or balance, stoop, kneel, crouch, or crawl, and may occasionally lift and/or move up to 50 pounds. Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to toxic and/or caustic chemicals and high potent compounds is possible; risk of electrical shock; normal noise level is moderate. Core Competencies
Scientific leadership in analytical chemistry for API synthesis Presentation and persuasion skills Training and facilitation skills Developed written and verbal communication skills Complete understanding of cGMP and GLP requirements Salary
Actual pay will be based on your skills and experience. Benefits
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service Accident Plan Critical Illness Insurance Dental Insurance Disability Insurance Employee Assistance Program Flexible Spending Account Health Insurance PPO/HSA Hospital Indemnity Plan ID Theft Protection Life Insurance Paid Maternity/Paternity Leave Tuition Reimbursement Wellness Program Vacation – Three Weeks 1st Year Vision Insurance This post will expire on 10/31/2025. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Corden Pharma - A Full-Service CDMO by 2x Sign in to set job alerts for “Analytical Chemist” roles.
Boulder, CO 92,000 - 110,000 and related geographic listings are included for context.
#J-18808-Ljbffr