What are the responsibilities and job description for the Purification Project Lead position at Corden Pharma Colorado?
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 group-level leadership for the Process Chemistry Department to provide results in order to meet business needs. Guides, directs, and reviews work done by Process Chemists to support the development of new pharmaceutical processes. The Purification Project Lead ensures the technical feasibility, economic competitiveness, and overall robustness of new and existing processes with a focus on preparative chromatography and TFF. The Purification Project Lead also supports and troubleshoots investigations into processes in non-commercial manufacturing.
The Purification Project Lead’s further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. Responsible for creating an environment that encourages technical excellence, developing, and coaching the group to improve skills, while ensuring high quality technical work.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Guides, directs, and reviews work done by their group to ensure an exceptional level of project performance
- Responsible and accountable for all aspects of project performance within their group. Including meeting technical, timeline, and budgetary objectives, as well as client satisfaction
- Ensures experimental plans are designed to ensure project objectives are met
- Takes the lead in customer and interdepartmental communications, or delegates to sufficiently trained and competent group members
- Enforces compliant working practices including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating practices in the labs, production areas, and office areas
- Manages performance of group members according to Corden standards and job descriptions
- Involved in professional development, recruiting, hiring, and promotions for the members of the group
- Applies principles of Continuous Improvement to ensure work processes and business processes are meeting business and client needs
LEADERSHIP & BUDGET RESPONSIBILITIES
Supervises and directs the group directly in cooperation with department manager and project managers. Responsible for effective communication within the group, the department, and externally to the site, other sites, and external customers as appropriate.
Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts.
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
PhD in Chemistry or equivalent combination of education and work experience. Five years of practical work experience in API Pharmaceutical Process Development with a focus on preparative chromatography and/or TFF, including all aspects of Process Chemistry from scale-up and process safety considerations to the API Regulatory approval process.
LANGUAGE SKILLS
The ability to write reports, proposals, contracts, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general 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
The ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagrammatic, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
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 sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; 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 25 pounds. Specific vision abilities required by this job include the 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 occasionally exposed to moving mechanical parts, fumes or airborne particles and noise typical of an office environment.
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.
- Advanced communication skills (oral and written) to interrelate with external customers and other departments within the company structure
- Expert abilities in the design of chemical processes, and in the implementation of common unit operations
- Ability to formulate and articulate a cohesive strategy for process development, including its regulatory aspects
- Administration - able to organize group to achieve group goals and objectives
- Analytical Methodologies – HPLC/UPLC, GC, IR, UV, IC, NMR
- Analytical Instrumentation – comfortable with the use of common analytical techniques
- Process Instrumentation – understanding of common development tools such as pressure vessels, large-scale lab equipment (20-50 L), optical analysis probes, parallel process development equipment, etc.
- Preparative Chromatography/TFF – understanding of all aspects of chemistry, development, and scale-up
- Regulatory Compliance – excellent working knowledge of ICH guidelines/USP/EP/JP, SME for inspections
- Quality Compliance – performing and supporting investigations, determinations of root cause, and preventative measures
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
- 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
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
This post will expire February 6, 2026
Salary : $110,000 - $125,500