Corden Pharma - A Full-Service CDMO

Technician

• Responsible for the safe manufacture of pharmaceutical intermediates and APIs within one of the Corden Pharma Colorado Manufacturing Centers of Excellence
• Performs various unit operations on raw materials and intermediates according to written manufacturing procedures and SOPs
• Familiar with hands-on operation of manufacturing process equipment and material handling
• Prepares equipment for maintenance and maintains a consistent high level of housekeeping
• Completes assigned tasks, thinking ahead to prepare for the next steps in processing
• Displays a high level of attention to detail and accuracy in their work

Manufacturing Technician – Associate

Supplier Quality

• Lead the end‑to‑end supplier lifecycle management program, including phase‑appropriate qualification, risk‑based assessment and classification, performance monitoring, audit strategy, and continuous improvement of supplier quality processes
• Ensure reliable, compliant, and market‑aligned material supply by evaluating and qualifying new suppliers, reviewing documentation and quality systems, and monitoring ongoing supplier performance through metrics, trending, and Quality Management Reviews (QMR)
• Develop and maintain supplier relationship and performance programs, including Supplier Relationship Management (SRM), supplier risk monitoring, second‑sourcing strategies, and ongoing business intelligence related to market trends and CDMO practices
• Plan, prioritize, and execute supplier audits using a risk‑based approach, including defining scopes, performing audits, issuing reports, ensuring timely closure of corrective actions, and maintaining an accurate and compliant Approved Supplier List (ASL)
• Serve as the technical escalation point for supplier quality issues, leading investigations into material defects, deviations, or supply disruptions; coordinating cross‑functional teams; managing supplier‑initiated change evaluations; and ensuring timely issue resolution
• Collaborate cross‑functionally with Supply Chain, R&D, Engineering, Project Management, Regulatory Affairs, and external suppliers to support risk mitigation, strengthen supplier partnerships, improve supplier quality systems, and enhance long‑term supply reliability
• Support external audits, regulatory inspections, and customer reviews by providing supplier qualification records, supplier oversight documentation, and subject matter expertise in Supplier Quality Management and compliance expectations
• Drive continuous improvement across the Supplier Quality Management Program by identifying process enhancements, updating procedures, mentoring SQM Team members, and fostering consistent application of supplier qualification, monitoring, and risk management practices

Senior Supplier Quality Management Specialist

QA Engineer

• Provides Quality Assurance related product leadership as it relates to planning and execution of products.
• Responsible for the collaboration, review, and approval of GMP documents.
• Represents a high-level of GMP understanding and accomplishment.
• Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality representative supporting the lifecycle of products for internal and external customers.
• Responsible for clear, direct, and appropriate communication in customer interactions.
• Provide process support including process validation, technical transfer, and commercial activities. May include clinical development as needed.
• Collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation.
• Collaborate, review, and approve minor and major investigations and Corrective Actions Preventative Actions (CAPAs).
• Create, report, and communicate product-related quality metrics to internal and external stakeholders.
• Assure that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs to ensure favorable quality inspections and customer satisfaction.
• Provide Quality leadership and decision-making on cross-functional teams that include but are not limited to Operations, Process Engineering, Quality Control, and Safety.
• Perform final product batch disposition.
• Assist in and represent Quality during internal and external audits and regulatory inspections.
• Perform other duties as needed to support CordenPharma initiatives and improvements.

QA Product Specialist

Engineer

• Provide process safety engineering technical expertise and leadership to ensure Corden facilities are operated in a manner that protects the health and safety of employees and the public; protects the environment; and provides regulatory compliance.
• Manage and coordinate all aspects of Process Safety Management (PSM) and Risk Management Plan (RMP) compliance standards.
• Define and prioritize site programs to meet the needs of regulatory compliance, risk analysis recommendations, and audit findings.
• Work with site resources to integrate these efforts into the manufacturing and development organizations.
• Provide functional oversight and guidance for PSM elements under the ownership of other departments.
• Develop and deliver PSM-required employee training.
• Establish means and methods for sharing relevant safety knowledge and lessons learned from industry experience.
• Develop the necessary process safety expertise, judgment, and initiative within the Corden workforce to continually strengthen the Process Safety Program.
• Implement, maintain, and continuously improve process safety policies, procedures, and systems.
• Ensure that the established PSM Program also meets the business needs of Corden.
• Establish relationships with other process safety resources within and outside of Corden to gain additional knowledge of industry practices, and to provide guidance and knowledge in return.

Senior Process Safety Engineer

• Performs research and development activities for the purpose of transferring and designing/improving a process or technology
• Provides process engineering support for manufacturing processes in assigned group or plant through developing and implementing continuous improvements
• Troubleshoots methods and equipment used in the production of bulk pharmaceutical intermediates and active pharmaceutical ingredients
• Provides day-to-day support to assigned processes, at times requiring attention outside of the normal work hours
• Evaluates new process fits into manufacturing with supervisory oversight
• Performs process development via process modeling or testing at lab scale
• Participates in technology transfer from one manufacturing site to another
• Develops plans for successful tech transfers, and implements processes into pilot or commercial facilities
• Assembles technology transfer packages
• Implements process improvements and optimization that reduce costs; improve yields, cycle times or product quality
• Supports manufacturing through compiling technical requirements for batch record generation
• Provides technical input on equipment setup requirements
• Writes process validation protocols; provides technical input on deviations and investigations

Chemical Process Engineer

General Counsel

• Lead legal advisor for Corden Pharma in the United States, responsible for providing pragmatic, business-oriented, legal support across Corden’s operations in Colorado and South Carolina.
• Provide strategic legal guidance, ensure regulatory compliance, and manage legal risks while partnering closely with business leaders.
• Lead the drafting, review, and negotiation of complex commercial agreements and other business transactions for Corden Pharma in the United States, including manufacturing, supply, development, procurement, and capital project agreements.
• Manage disputes affecting the U.S. business, including litigation, arbitration, and settlements, in coordination with external counsel as appropriate.
• Monitor, advise, and develop mitigation strategies on legal and regulatory developments relevant to the U.S. business.
• Provide practical, business-oriented legal advice to Corden Pharma’s U.S. functions and sites on commercial, corporate, compliance, operational, and other matters.
• Develop and maintain legal templates, tools, policies, and guidance materials to support the business efficiently and consistently.
• Provide legal training and practical guidance to internal stakeholders on relevant legal and compliance topics.
• Work closely with global legal and cross-functional teams to support effective collaboration across functions, sites, and external stakeholders.
• Lead legal projects as assigned by the General Counsel.
• Support the General Counsel on strategic initiatives, integrations, M&A matters, and selected corporate finance transactions.

Director, Corporate Counsel

• Leads and assists in Quality Assurance related projects and day-to-day quality activities as needed
• Represents the highest level of GMP understanding and accomplishment.
• Supports the Quality Assurance Department in the following functions/projects.
• Responsible for improving the efficiency and effectiveness of all engineering related quality systems.
• Will have responsibility for generating or reviewing and approving the following document types: Equipment Qualification documents, Temperature Mapping, Water System Utilities, Environmental Monitoring, Risk Assessments, Cleaning, Write protocols and reports, Annual Product Reviews
• Provide guidance and leadership where appropriate.
• Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace.

Operations

• Consolidation of site demand planning, site supply and asset planning, and managing site planning intersections with global integrated planning processes to ensure capacity availability aligns with client demands
• Drive site SIOP process and strategy through collaboration with team to ensure success of site sales and resource utilization plans
• Mapping and documenting processes: Identify areas for improvement and gaps in existing processes
• Effectively manage/set key performance indicators to monitor the effectiveness of SIOP processes
• Lead processes to forecast Inventory (API and key intermediate) to drive optimal inventory levels, balance plant flexibility, and minimize stockouts and product expiration
• Translate site capacity to global partners to facilitate sales and forecasting meetings
• Develop and implement site resource planning processes to ensure forecasting and planning of key resource groups are aligned with budget and SIOP processes
• Develop and deliver SIOP and Resource/Capacity Planning training programs to enhance organizational engagement
• Work with IT teams to design reports, dashboards, and processes that improve business planning and communication at the site level and above site

Senior Sales, Inventory, and Operations Planning Specialist – SIOP

Analyst

• The Manufacturing Production Analyst is a high-impact, cross-functional role responsible for delivering data-driven insights that improve manufacturing performance, program execution, and financial outcomes across both commercial production and development pipelines.
• This role sits at the intersection of Operations, Planning, Program Management, Quality, and Finance, translating complex operational data into actionable intelligence that drives throughput, yield, and profitability.
• Maintain KPIs and dashboards for batch success rates, yield variance, cycle times and capacity utilization.
• Analyze batch-level performance to understand and report production and cost variances, with clearly quantified drivers.
• Partner with Manufacturing and MSAT to support continuous improvement initiatives, Tech transfer performance, and financial impact of production deviations.
• Provide Site Leadership Team with real-time operational insights to support Tier meetings.
• Support development program tracking across all phases: Timeline adherence vs. plan, Resource utilization (lab capacity, scientist allocation), Cost-to-complete and burn rate.
• Collaborate with BI team to develop and maintain standardized reporting.

Manufacturing Production Analyst

Accounting Manager

• Apply concrete experiences and abstract principals to chemical manufacturing and/or development activities.
• Perform simulations, scale-up calculations, investigations, and laboratory work, and/or evaluate manufacturing data, perform statistical analysis, and write technical reports of manufacturing campaigns.
• Potential to propose and implement process improvements.
• Become familiar with cGMP operations and documentation.
• Demonstrate problem-solving skills within interdisciplinary team environments.
• Acquire new skills and expand competency in support of project goals.
• Collaborate with supervisors, mentors, and team members to achieve assigned objectives and deadlines.
• Develop and apply skills supporting accounting processes, financial analysis, and business operations.
• Prepare and deliver a summary presentation outlining key learnings and contributions at the conclusion of the assignment.