Principal Purification Chemist

Corden Pharma Colorado• Boulder, CO, US, CO

3d•Onsite

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. RESPONSIBLE FOR PROVIDING STRONG TECHNICAL LEADERSHIP AND DOCUMENTATION SUPPORT FOR DEVELOPMENT AND GMP MANUFACTURING PROCESSES. RESPONSIBLE FOR THE PLANNING AND EXECUTION OF MULTI-STEP PREPARATIVE CHROMATOGRAPHY FROM LABORATORY TO FULL COMMERCIALIZATION. EMPHASIS IS ON THE CREATIVE APPLICATION OF A FULL RANGE OF LITERATURE AND THEORETICAL CONCEPTS, FROM A DIVERSE RANGE OF CHEMISTRY TO THE DESIGN AND IMPLEMENTATION OF COST-EFFECTIVE PROCESSES FOR THE MANUFACTURE OF CORDEN PHARMACEUTICALS. WORKS WITHIN A TEAM-ORIENTED ENVIRONMENT WITH PROFESSIONALS FROM A VARIETY OF DISCIPLINES. CONDUCTS RESEARCH, ANALYSIS, SYNTHESIS, EXPERIMENTATION, AND DOCUMENTATION FOR SUCH PURPOSES AS PROCESS DEVELOPMENT, IMPLEMENTATION, REGISTRATION, VALIDATION, AND PROCESS IMPROVEMENT.

Requirements

DOCTORAL DEGREE (PH.D.) IN CHEMISTRY AND ONE YEAR OF POSTDOCTORAL EXPERIENCE, PREFERABLY SPECIALIZING IN PURIFICATION CHEMISTRY, PLUS FIVE YEARS OF EXPERIENCE; OR EQUIVALENT COMBINATION OF EDUCATION AND EXPERIENCE IN A PHARMACEUTICAL OR FINE CHEMICAL MANUFACTURING ENVIRONMENT.
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 COMPREHEND AND APPLY PRINCIPLES OF ADVANCED CALCULUS, MODERN ALGEBRA, AND ADVANCED STATISTICAL THEORY.
ABILITY TO WORK WITH CONCEPTS SUCH AS LIMITS, QUADRATIC AND EXPONENTIAL EQUATIONS, AND PROOFS OF THEOREMS.
ABILITY TO APPLY PRINCIPLES OF LOGICAL OR SCIENTIFIC THINKING TO A WIDE RANGE OF INTELLECTUAL AND PRACTICAL PROBLEMS.
ABILITY TO DEAL WITH NONVERBAL SYMBOLISM (FORMULAS, SCIENTIFIC EQUATIONS, GRAPHS, ETC.,) IN ITS MOST DIFFICULT PHASES.
ABILITY TO DEAL WITH A VARIETY OF ABSTRACT AND CONCRETE VARIABLES.
Maintains a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports
Experience in the purification of Peptides
Thorough knowledge of all plant-scale purification unit operations, scale-up, and plant design considerations
An understanding of chemical reactivity, process hazards, cross reactivity, side products, and waste streams, especially for processes they support
Regularly seeks out new learning opportunities beyond basic skills that can result in innovative approaches to technical issues
Demonstrates clear understanding of technical issues and the requirements of a viable manufacturing process; has demonstrated independent support on multiple (not necessarily simultaneous) processes
Identifies areas where change/continuous improvement is beneficial to the business, and successfully defends and implements projects
Assumes reasonable risk in trying out new, self-generated ideas
Proactive approach to problem identification and resolution
Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective, and effective
Ability to understand and apply statistical design of experiments and draw sound conclusions from the results; uses results when solving problems or proposing improvements
Ability to provide leadership in all purification chemistry aspects of manufacturing processes; leads teams in the development, transfer, troubleshooting, and improvement of chemical processes in an interactive, interdisciplinary team environment
Seeks out opportunities to learn manufacturing needs and methods that facilitate substantial process improvements; acquires new skills in state-of-the-art technology and applies it to their assignments
Demonstrates skills in negotiation and influencing others
Thorough working knowledge of regulatory issues in pharmaceutical manufacturing including cGMPs, PSM, OSHA, EPA requirements, and process hazard analysis; can interpret regulatory laws, and propose, defend, and implement cost-effective solutions
Computer skills, in the areas of Microsoft Office Products – Word, Excel, PowerPoint, statistical analysis programs, Laboratory Information Management System (LabVantage), electronic notebook system (Signals), Openlab, Smartsheets, and business systems (SAP)
Develops special expertise in products and processes; acknowledged as an expert in one or more technical areas both within and outside site
Creates clear, concise goals, and strategies that support individuals’ development and the site’s mission; actively participates in proposing and setting purification/Process Chemist Group and Manufacturing Department goals
Routinely demonstrates a proactive approach to problem identification and resolution
Understands Corden’s business goals and contributes technically to its strategy development
Interacts with management in developing project objectives and site strategies; advises management regarding technical opportunities and advances

Nice To Haves

Preferably specializing in purification chemistry

Responsibilities

Ensures that the purification chemistry is capable of meeting cost, yield, throughput, quality/purity, and QSHE goals on assigned processes in GMP plant production
Leads the technical progress of large and/or multiple teams to accomplish the development, transfer, or implementation of technology at a lab or plant scale
Develops and supports scalable purification processes and provides technical expertise and support during lab or GMP plant operations
Responsible for supplying management with specific project data to facilitate the budgeting process for the development, transfer, or implementation of technology
Develops and executes procedures, processes, and methods for solutions to purification and technical problems on lab and plant scale
Conducts research and development to improve manufacturing processes
Troubleshoots purification processes running in lab and GMP plant manufacturing
Possesses an individual area of technical expertise, which others consult them for advice
Adheres to GDP and SOPs in all aspects of work
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 purification and analytical processes.
Gives regular reports to, and actively solicits feedback from, management.
Every individual is personally responsible for the safety and environmental aspects of their 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.
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products.
In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable.
This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy.
CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective.
Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards.
Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

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