Principal Analytical Chemist

Corden Pharma Colorado

About The Position

CORDENPHARMA IS A LEADING FULL-SERVICE CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION (CDMO) SPECIALIZING IN ACTIVE PHARMACEUTICAL INGREDIENTS (APIS), EXCIPIENTS, DRUG PRODUCTS (DPS), AND PACKAGING. WITH AROUND 3,000 EMPLOYEES WORLDWIDE, WE HELP PHARMACEUTICAL AND BIOTECH COMPANIES MANUFACTURE MEDICINES WITH THE ULTIMATE GOAL OF IMPROVING PEOPLE’S LIVES. OUR NETWORK, SPANNING EUROPE AND THE U.S., PROVIDES FLEXIBLE AND SPECIALIZED SOLUTIONS ACROSS SIX TECHNOLOGY PLATFORMS: PEPTIDES, LIPIDS & CARBOHYDRATES, INJECTABLES, HIGHLY POTENT & ONCOLOGY, SMALL MOLECULES, AND OLIGONUCLEOTIDES. WE STRIVE FOR EXCELLENCE IN SUPPORTING THIS NETWORK AND ARE COMMITTED TO DELIVERING THE HIGHEST QUALITY PRODUCTS FOR PATIENT WELL-BEING. OUR PEOPLE VISION WE STRIVE FOR EXCELLENCE. WE SHARE OUR PASSION. TOGETHER, WE MAKE A DIFFERENCE IN PATIENTS' LIVES. SUMMARY 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.

Requirements

Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience.
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.
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.
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.
Domestic and international travel required.
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

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.
Responsible for participating 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.

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 Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance