Principal Process Chemist - Peptide Focus

Job Description

Job Description

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

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned

• 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

LEADERSHIP & BUDGET RESPONSIBILITIES

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.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

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.

QUALITY RESPONSIBILITIES

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.

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

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.

LANGUAGE SKILLS

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.

 

MATHEMATICAL SKILLS

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.

REASONING ABILITY

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.

CERTIFICATES, LICENSES, REGISTRATIONS

Domestic and international travel required.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill, and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• 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

 

SALARY

Actual pay will be based on your skills and experience.

 

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service 
• Accident Plan