Principal Process Chemist - Peptide Focus

Corden Pharma Colorado• Boulder, CO, US, CO

1d•$122,000 - $153,000•Onsite

About The Position

Responsible for providing strong technical leadership and documentation support for development and GMP manufacturing processes in the area of peptide manufacturing. Responsible for the planning and execution of multi-step syntheses from laboratory to full commercialization and supporting commercialization in the plant. 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 (PhD) in Organic Chemistry/Biochemistry ideally with strong expertise in Peptide Chemistry (SPPS, LPPS, Fragment Synthesis), plus 5 years of industrial experience ideally at a CDMO; or equivalent combination of education and experience; including demonstrated success in Synthetic Organic Synthesis in a CDMO, Pharmaceutical or Fine Chemical Manufacturing Environment.
Peptide experience required.
Proven track record in developing manufacturing processes suitable for large scale production > 100 kg.
Strong knowledge in working in multidisciplinary teams during tech transfer.
Experience with ICH guidelines, GMP, and regulatory CMC expectations.
Ability to write reports, proposals, contracts, business correspondence, and procedure manuals.
Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.
Ability to convert units of measurement.
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.
Deep expertise in peptide synthesis technologies and optimization
Strong understanding of analytical methods for peptide characterization (LC‑MS, HPLC, purity profiling)
Maintains a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports
Experience in the development and manufacturing (including purification, concentration via TFF and isolation) of peptides by Lyophilization and precipitation
Has thorough knowledge of all plant-scale unit operations, scale-up, and plant design considerations
Understanding of chemical reactivity, potential exotherms, cross reactivity, side products, and waste streams; and 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. Demonstrated independent support on multiple (not necessarily simultaneously) 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 Process 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, GDP, FDA, ICH, PSM, OSHA, EPA requirements, and process hazard analysis; can interpret regulatory laws, and propose, defend, and implement cost-effective solutions. Familiar with concepts of process validation
Computer skills, in the areas of: Microsoft Office Products – Word, Excel, PowerPoint; statistical analysis programs, Chemdraw and SciFinder, electrical notebook system (Signals), Laboratory Information Management System, 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 the site
Creates clear, concise goals and strategies that support individuals’ development and the site’s mission; actively participates in proposing and setting 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
Demonstrates a positive attitude
Interacts with management in developing project objectives and site strategies; advises management regarding technical opportunities and advances

Responsibilities

Ensures that the chemistry is capable of meeting cost, yield, throughput, and QSHE goals on assigned processes in GMP plant production
Complete knowledge of peptide development and production: synthesis (SPPS, LPPS, Fragment Synthesis), crude, cyclization, purification, Lyophilization, and isolation by precipitation
Leads in a matrix environment large and/or multiple teams to accomplish the peptide process development, transfer, or implementation of technology at a lab or GMP plant scale
Strong knowledge and practical application of Quality by Design (QbD) principles, including: Definition of QTPP, CQAs, CMAs, and CPPs; Risk assessments (e.g., FMEA, Ishikawa); Design of Experiments (DoE) and multivariate data analysis; Strong knowledge of relevant ICH guidelines, ICHQ3A, Q3C, Q3B, Q3D, Q11, Q10, Q9, and ICHM7R(2)
Develops and supports scalable peptide processes and provides technical expertise and support during lab and GMP plant operations
Responsible for supplying management with specific project data to facilitate the budgeting process for the development, transfer, and/or implementation of technology
Develops and executes procedures, processes, and methods for solutions to chemical and technical problems on lab and/or plant scale
Conducts research and development to improve manufacturing processes, improve on costs profile and process yield and throughput
Possesses an individual area of technical expertise, which others consult them for advice
Collaborates closely with Analytical Development, Manufacturing, QA, Regulatory, and external partners
Provides expert input on project timelines, risks, and mitigation strategies
Adheres to GDP and SOPs in all aspects of work
Demonstrates a 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 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