Principal Purification Chemist

Corden Pharma Colorado • Boulder, CO, US, CO

41d • $122,000 - $153,000 • 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. This role is responsible for providing strong technical leadership and documentation support for development and GMP manufacturing processes. It involves the planning and execution of multi-step preparative chromatography from laboratory to full commercialization, with an emphasis on the creative application of literature and theoretical concepts to design and implement cost-effective processes. The role operates within a team-oriented environment and conducts research, analysis, synthesis, experimentation, and documentation for process development, implementation, registration, validation, and 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
• Leads team in the development, troubleshooting, transfer, and improvement of purification and analytical processes
• Gives regular reports to, and actively solicits feedback from, management

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree