Sr. Analytical Chemist

CordenPharma•Boulder, CO

69d

About The Position

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives. Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients. SUMMARY Performs 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 or Master's degree in Chemistry with 2 years of related experience; or BS degree with 6 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, 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.
Presentation and persuasion skills
Training and facilitation skills
Developed written and verbal communication skills
Complete understanding of cGMP and GLP

Responsibilities

Participates in development of new processes by applying analytical skills and training. The required skills may, depending upon the focus of the position, need to include advanced technologies, such as mass spectroscopy (MS, LC/MS, LC/MS/MS, and GC/MS)
Applies analytical techniques at a process scale (e.g., process chromatography)
Initiates and executes development of new and innovative analytical chemistry and methodology
Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden Pharma Colorado (CPC) Stability Program
Provides written analytical procedures and reports supporting clinical manufacturing, commercial manufacturing, and regulatory needs. Facilitates and supports analytical technology transfers
Develops key technologies and transfer strategies that function well in a manufacturing environment
Responsible for the analytical sections of process procedures
Serves as analytical resource on R&D teams
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
Develops, implements, and validates analytical methods and procedures
Practices good communication skills and maintains documentation such as records of expenditures and research findings, progress reports, and staff conferences, in order to inform management of current status of each project
Participates in manufacturing site activities, such as troubleshooting and analytical problem resolving
Develops an understanding of QEH&S principles and regulatory affairs
Analyzes and releases batches of drug substance and/or intermediates to be used in clinical or registration programs
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
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft
Life Insurance
Paid Maternity/Paternity Leave
Tuition Reimbursement
Wellness Program
Vacation - Three Weeks 1st Year
Vision Insurance