Qureos Mentor

CORDENPHARMA

<div><h2 class="jobSectionHeader"><b>CORDENPHARMA</b><b> </b><b>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&rsquo;S LIVES.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
OUR NETWORK, SPANNING EUROPE AND THE U.S., PROVIDES FLEXIBLE AND SPECIALIZED SOLUTIONS ACROSS SIX TECHNOLOGY PLATFORMS: PEPTIDES, LIPIDS &amp; CARBOHYDRATES, INJECTABLES, HIGHLY POTENT &amp; 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.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
OUR PEOPLE VISION</b></h2><h2 class="jobSectionHeader"><b>
WE STRIVE FOR EXCELLENCE. WE SHARE OUR PASSION. TOGETHER, WE MAKE A DIFFERENCE IN PATIENTS' LIVES.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
SUMMARY</b></h2><div>
Acts to drive and demonstrate the technology for the planning and execution of development and implementation of chemical processes. Ensures that the chemistry is sufficient to meet goals on process yields, throughputs, and QSHE requirements.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
ESSENTIAL DUTIES AND RESPONSIBILITIES</b></h2><div>
Include the following. Other duties may be assigned:</div><br>
<div></div><ul><li>
Familiarity with general TFF/ultra filtration setup, operation, and components</li><li>
Experience with lab and/or mid-large scale TFF/ultra filtration processing</li><li>
Knowledge of various types of TFF filtration methods and systems</li><li>
Understanding of key operating/scalable parameters for TFF/ultra filtration and ability to determine such parameters during process familiarization/optimization</li><li>
Provides technical support to lab or plant processes</li><li>
Works effectively in a team-oriented environment</li><li>
Presents work orally and in form of written development reports</li><li>
Adheres to GDP and SOPs in all aspects of work</li><li>
Independently plans and executes experiments, while working in a project team, toward development of viable commercial processes</li><li>
Demonstrates a clear understanding of technical issues and the requirements of a viable manufacturing process</li><li>
Executes procedures, processes, and methods for solutions to chemical and technical problems on a lab or plant scale</li><li>
Ensures that the chemistry is capable of meeting cost, yield, throughput, and QSHE goals on assigned processes</li><li>
Leads a team to accomplish the development, transfer, or implementation of technology at a lab or plant scale</li><li>
Develops and supports scalable processes and provides technical expertise and support during lab or plant operations</li></ul><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
LEADERSHIP &amp; BUDGET RESPONSIBILITIES</b></h2><div>
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. This position has no supervisory responsibilities. Provides technical expertise to manufacturing.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
SAFETY &amp; ENVIRONMENTAL RESPONSIBILITIES</b></h2><div>
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.</div><div><b><br>
QUALITY RESPONSIBILITIES</b></div><div>
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&rsquo;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.</div><div></div><div><br>
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.</div><div></div><h2 class="jobSectionHeader"><b><br>
QUALIFICATIONS</b></h2><div>
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.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
EDUCATION and/or EXPERIENCE</b></h2><div>
Bachelor&rsquo;s Degree (BS) in Organic Chemistry and 5 years related experience and/or training; or equivalent combination of education and experience. TFF/Untra filtration experience is required; and Peptide and GMP experience is a plus.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
LANGUAGE SKILLS</b></h2><div>
Ability to read, analyze, and interpret common scientific and technical 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 develop bench scale laboratory procedures into step-by-step operating instructions for chemical operators. Ability to effectively present information to top management, public groups, and/or boards of directors.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
MATHEMATICAL SKILLS</b></h2><div>
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
REASONING ABILITY</b></h2><div>
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. Ability to apply scientific methods to experimentally prove cause and effect.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
CERTIFICATES, LICENSES, REGISTRATIONS</b></h2><div>
Domestic and international travel required.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
PHYSICAL DEMANDS</b></h2><div>
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.</div><div></div><div><br>
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 must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
WORK ENVIRONMENT</b></h2><div>
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.</div><div></div><div><br>
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The noise level in the work environment is usually moderate.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
CORE COMPETENCIES</b></h2><div>
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.</div><br>
<div></div><ul><li>
Demonstrates a positive attitude</li><li>
Strong background in chemistry or a related scientific field</li><li>
Working knowledge of regulatory issues in Pharmaceutical Manufacturing including cGMPs, GDP, FDA, PSM, OSHA, and EPA requirements</li><li>
Communicates effectively in writing and verbally within the department</li><li>
Computer skills, in the areas of: Microsoft Office Products (Word, Excel, PowerPoint), Chemdraw, and SciFinder</li><li>
Ability to work interactively within a multi-functional team-oriented environment</li><li>
Takes initiative in setting own goals and work plans</li><li>
Hands-on organic chemistry laboratory experience</li><li>
Has a broad technical knowledge in Organic Chemistry and Process Improvement Methodology</li><li>
Maintains a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports</li><li>
Experience in the synthesis and purification of peptides (desired)</li><li>
Has working knowledge of all plant-scale unit operations, scale-up, and plant design considerations</li><li>
Understanding of chemical reactivity, potential exotherms, cross reactivity, side products, and waste streams, especially for processes they support</li><li>
Regularly seeks out new learning opportunities beyond basic skills that can result in innovative approaches to technical issues</li><li>
Demonstrates clear understanding of technical issues and the requirements of a viable manufacturing process; has demonstrated independent support on multiple (not necessarily simultaneous) processes</li><li>
Identifies areas where change/continuous improvement is beneficial to the business, and successfully defends and implements projects</li><li>
Assumes reasonable risk in trying out new, self-generated ideas</li><li>
Proactive approach to problem identification and resolution</li><li>
Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective, and effective</li><li>
Ability to understand and apply statistical design of experiments and draw sound conclusions from the results; uses results when solving problems or when proposing improvements</li><li>
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 interactive, interdisciplinary team environment</li><li>
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</li><li>
Demonstrates skills in negotiation and influencing others</li></ul><p><b>
SALARY</b></p><div>
Actual pay will be based on your skills and experience</div><div></div><h2 class="jobSectionHeader"><b><br>
BENEFITS</b></h2><ul><li>
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service</li><li>
Accident Plan</li><li>
Critical Illness Insurance</li><li>
Dental Insurance</li><li>
Disability Insurance</li><li>
Employee Assistance Program</li><li>
Flexible Spending Account</li><li>
Health Insurance PPO/HSA</li><li>
Hospital Indemnity Plan</li><li>
ID Theft Protection</li><li>
Life Insurance</li><li>
Paid Parental Leave</li><li>
Tuition Reimbursement</li><li>
Wellness Program</li><li>
Vacation &ndash; Three Weeks 1st Year</li><li>
Vision Insurance</li></ul><h2 class="jobSectionHeader"><b>
EQUAL OPPORTUNITY EMPLOYER</b></h2><div><i>
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.</i></div><p></p><p><br>
This post will expire December 12, 2025</p></div>

Sr. Process Chemist - TFF focus

<p></p><div><h2 class="jobSectionHeader"><b>CordenPharma </b><b>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&rsquo;s lives.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids &amp; Carbohydrates, Injectables, Highly Potent &amp; 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.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
Our People Vision</b></h2><h2 class="jobSectionHeader"><b>
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
SUMMARY</b></h2><h2 class="jobSectionHeader"><b>
This role will have responsibility for Quality Systems and Compliance Management including Deviation, CAPA, and Change Control Quality oversight, Master Control oversight, Supplier Quality Management (SQM), Document Control and Document Management, Regulatory Inspections and Client Audit oversight, and Quality Metrics. The Associate Director of Quality Systems and Compliance will lead monthly Quality Management Review (QMR) and will drive Quality and Site Metrics for the Colorado Corden site.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
ESSENTIAL DUTIES AND RESPONSIBILITIES</b></h2><div>
Include the following. Other duties may be assigned.</div><div></div><div><br>
<ul><li>
Oversight of Deviations (Quality Systems)</li><li>
Oversight of CAPAs (Quality Systems)</li><li>
Oversight of the Change Control Program</li><li>
Oversight of Master Control</li><li>
Oversight of Regulatory Inspections and Client Audits (oversee Quality Compliance Manager)</li><li>
Oversee Document Control and Document Management</li><li>
Oversee Supplier Quality Management (SQM)</li><li>
Organize and lead monthly Quality Management Review (QMR)</li><li>
Drive compliance and gap assessments for Corporate Standards</li><li>
Drive and provide regular metrics updates to the Leadership Team and site</li><li>
Participate in Global Corden Quality Systems discussions</li><li>
Exceptional Management Skills</li><li>
Exceptional Communication Skills (both written and verbal)</li><li>
Strong Quality and Regulatory knowledge</li><li>
Ability to transform and drive improvement to systems and organizations</li></ul></div><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
LEADERSHIP &amp; BUDGET RESPONSIBILITIES</b></h2><h2 class="jobSectionHeader"><b>
Provide strong leadership to the organization and be able to collaborate well cross-functionally. Provides guidance, and partners with the Head of QA and QC to stay within budget and determine budget requirements year over year.</b></h2><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
SAFETY &amp; ENVIRONMENTAL RESPONSIBILITIES</b></h2><div>
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.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
QUALITY RESPONSIBILITIES</b></h2><div>
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&rsquo;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.</div><div></div><div><br>
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.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
QUALIFICATIONS</b></h2><div>
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.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
EDUCATION and/or EXPERIENCE</b></h2><div>
BA or BS (scientific degree preferred) from a four-year university ; and 15 years of related experience; or equivalent combination of education and experience. Strong Quality background and experience is a must</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
LANGUAGE SKILLS</b></h2><div>
Ability to read, analyze, and interpret general business periodicals, professional</div><div>
journals, technical procedures, or governmental regulations. Ability to write reports,</div><div>
business correspondence, and procedure manuals. Ability to effectively present</div><div>
information and respond to questions from groups of managers, clients, customers,</div><div>
and the public.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
MATHEMATICAL SKILLS</b></h2><div>
Ability to work with mathematical concepts such as probability and statistical</div><div>
inference. Ability to apply concepts such as fractions, percentages, ratios, and</div><div>
proportions to practical situations.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
REASONING ABILITY</b></h2><div>
Ability to add, subtract, multiply, and divide in all units of measure, using whole</div><div>
numbers, common fractions, and decimals. Ability to compute rate, ratio, and</div><div>
percent, and to draw and interpret bar graphs.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
CERTIFICATES, LICENSES, REGISTRATIONS</b></h2><div>
None.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
PHYSICAL DEMANDS</b></h2><div>
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.</div><div></div><div><br>
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.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
WORK ENVIRONMENT</b></h2><div>
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.</div><div></div><div><br>
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.</div><h2 class="jobSectionHeader"><b><br>
</b></h2><h2 class="jobSectionHeader"><b>
CORE COMPETENCIES</b></h2><div>
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.</div><div></div><div><br>
<ul><li>
Leadership and deep knowledge of the concepts (above described as responsibilities)</li><li>
Governance and decision making regarding regulatory compliance and operational knowledge of API manufacture</li><li>
Effective in prioritizing workloads, resolution of issues based on compliance, and scientifically documented risk</li><li>
Excellent customer service skills</li><li>
Business acumen to drive successful customer experience while meeting business targets from a Quality perspective</li><li>
Good written and oral communication skills</li><li>
Computer skills with intermediate ability to use Microsoft Office Suite</li><li>
Strong planning, implementation, and follow-up skills</li><li>
Good facilitation skills and ability to interact with colleagues from all levels of the organization</li><li>
High analytical capabilities</li></ul></div><h2 class="jobSectionHeader"><b>
</b></h2><h2 class="jobSectionHeader"><b>
SALARY</b></h2><div>
Actual pay will be based on your skills and experience</div><div></div><h2 class="jobSectionHeader"><b><br>
BENEFITS</b></h2><ul><li>
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service</li><li>
Accident Plan</li><li>
Critical Illness Insurance</li><li>
Dental Insurance</li><li>
Disability Insurance</li><li>
Employee Assistance Program</li><li>
Flexible Spending Account</li><li>
Health Insurance PPO/HSA</li><li>
Hospital Indemnity Plan</li><li>
ID Theft Protection</li><li>
Life Insurance</li><li>
Paid Parental Leave</li><li>
Tuition Reimbursement</li><li>
Wellness Program</li><li>
Vacation &ndash; Three Weeks 1st Year</li><li>
Vision Insurance</li></ul><h2 class="jobSectionHeader"><b>
EQUAL OPPORTUNITY EMPLOYER</b></h2><div><i>
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.</i></div><p></p><p><br>
This post will expire November 24, 2025</p></div>

Associate Dir., Quality Systems and Compliance

Join CORDENPHARMA and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

CORDENPHARMA

ABOUT_COMPANY

Sr. Process Chemist - TFF focus

Associate Dir., Quality Systems and Compliance