Corden Pharma - A Full-Service CDMO

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.

Accounting Operations Intern

Operations

• The Principal Operations 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
• Build analytics around: Scale-up success rates, Process robustness indicators
• Partner with Program Management to identify risks to milestones and deliverables
• Translate operations into financial outcomes (Cost per batch / per Kg; Yield impact on margins; Absorption and utilization metrics)
• Support Product profitability analysis and Standard vs. actual cost variance analysis

Principal Operations Analyst

QA Engineer

• Provides Quality Assurance related project assistance as it relates to analytical methods and specifications for both development and commercial products.
• Responsible for providing strong Quality leadership and scientific/GMP information support to the plant-site as the Quality representative for new products/projects.
• Supports analytical aspects of new product introduction.
• Responsible for review and approval of protocols, and reports for stability and reference standards.
• Serves as QA liaison on product/project implementation teams.

QA Analytical Project Specialist

• The SAP SME will contribute to the SAP S/4HANA implementation at the Corden Pharma Colorado sites, working both independently and as part of the implementation team, being accountable for all aspects of Master Data-Business Partners within the project.
• Works closely with project team members to ensure successful project delivery.
• Collaborates with business stakeholders to understand needs and translate into business requirements for the SAP implementation.
• Enthusiastically learns the Corden Pharma global SAP S/4HANA template functionality.
• Prepares migration data files according to technical requirements – identifies, cleanses, and maps source data to target data.
• Provides input and makes decisions for system authorizations assigned to SAP S/4 users in area(s) of responsibility.
• Conducts thorough testing of SAP solutions to ensure functionality, stability, and data integrity; identifies and ensures resolution of test issues; gives business approval of test results.
• Provides end-user support post go-live during the hypercare period of the SAP project.

Warehouse Operations SAP SME

• Administers Quality Assurance programs, procedures, and controls ensuring that performance and quality of products conform to established Corden standards and federal regulations.
• Works directly with manufacturing and support groups to address quality issues with cGMP activities.
• Participates in validation activities related to processes and computer-related systems, as well as general QA areas of responsibility.
• Reviewing Validation, Qualification, and Change Control Documents for adequacy and adherence to cGMPs and Corden SOPs.
• Acting as the QA Representative on project teams as needed.
• Is the QA Generalist and resource on cGMP issues, who understands cGMP, Data Integrity, and GDP requirements and expectations.
• Participates in customer audits and regulatory inspections, which may include defending systems, formulating responses, or owning associated CAPA records.
• Reviews completed/executed batch records in support of lot release.
• Compiles supporting data/information for lot release.
• Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API.
• Reviews and approves stability reports, SOP/document revisions, methods, specifications, validation documents, and miscellaneous cGMP documents that require QA approval.
• Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department, which includes managing the records database (TabFusion) and off-site records storage (Iron Mountain).
• Serves as overall back up to other Quality personnel as appropriate.

Senior QA Associate

Engineer

• The Project Engineer is responsible for managing and executing capital projects in support of pharmaceutical drug substance, intermediates and fine chemical development and production.
• The project engineer manages multiple, high-value projects over a diverse number of disciplines including civil; mechanical; equipment & facilities design & installation; technology transfer; and product delivery.
• Ensures project cost, schedule and quality control, and adherence to regulatory laws and practices throughout the project life cycles are central to this position.
• Works with the project owner and supporting staff to develop the project business case and project objectives.
• Helps generate and communicate (i.e., presentations) and effectively build consensus for proposals with project stakeholders, as well as management.
• Plans, develops, and coordinates engineering efforts, with supervisory oversight, for projects while ensuring project success.

Project Engineer

Software Engineer

• The Project Engineering Group Lead is responsible for providing technical leadership for project engineers; as well as managing and executing capital projects in support of pharmaceutical drug substance, intermediates, and fine chemical development and production.
• Provides strong technical leadership in the areas of civil, mechanical, and equipment and facilities design and installation projects.
• Also, providing leadership to ensure project costs, schedules, quality control, and adherence to regulatory laws and practices throughout the project life cycles.
• Interacting with management in developing project objectives, department goals, and site concepts and strategies; advises management regarding technical opportunities and advances.
• Takes a lead role in working with the project owner and supporting staff to develop the project business case and project objectives.
• Ensures relevant alternatives are evaluated and the recommended solution is supported by local staff and management.
• Plans, develops, coordinates, and directs the entire engineering effort for assigned projects; and mentors and coaches on other projects with many complex features, while ensuring project success.
• Directs efforts relating to the generation of cost estimates, as well as cost and schedule tracking.
• Proactively demonstrates responsibility for ensuring that cost, scope, and schedule requirements are met.

Project Engineering Group Lead

Project Manager

• Manage resources and cross-functional efforts to successfully achieve customer deliverables and project objectives for contracted development and technical transfer of active pharmaceutical ingredients at Corden Pharma.
• Provide leadership and mentoring to other Project Managers as assigned.
• Project Manager for New Product Introduction Drive adherence to Corden’s contractual commitments: develop project plan including resources, timing, milestones, and deliverables.
• Track, monitor, and report key performance metrics including expenditures vs. budget.
• Manage and control multiple projects to meet objectives.
• Act as a liaison between Corden Pharma and customer project manager to ensure mutual agreement of contract scope and schedule.
• Monitor trends and drive continuous improvement of the project management process.
• Develop and distribute periodic reports on project performance, issues, risks, and schedules of key activities, events, or milestones.
• Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect project performance goal.
• Ensure risk assessments and appropriate risk mitigation plans are established for projects at every phase of the contract.
• Collaborate with R&D, Quality, and Operations to understand critical to quality product requirements.
• Lead and coordinate the preparation of Proposals for New Business RFPs. Lead preparation of Proposals for scope additions to existing Development Projects.
• Act as a sounding board and provide feedback to assigned Project Managers.
• Assist in the onboarding and professional development activities.

Senior Project Manager

Business Development Rep

• Identify customers in Northern Europe, directly or with the support of the Commercial Head, Marketing or other team members, who are a good fit for Corden Pharma and drive the business opportunities from prospecting to closure.
• Discuss and develop a strategy together with the Commercial Head to grow the business in the territory.
• Manage a group of diverse Biotech and Pharma customers representing the Drug Product (Injectables) Unit.
• Negotiate and close the sales opportunities according to the Business Plan.
• Establish a customer visit plan for the territory and involve key stakeholders whenever needed.
• Provide input on project pricing, timelines and competitive landscape to drive towards closing the opportunity.
• Work closely with the site to structure the proposal based on customer expectation.
• Provide input to the line manager to establish business cases for selected projects.
• Identify new clinical and commercial opportunities for Drug Product Unit (Injectables) and generate cross selling opportunities for other Business Units.
• Contact prospects and customers (phone, face to face visits, emails, conferences and trade shows) in pharma, biotech and diagnostic fields.
• Present information on Corden Pharma capabilities and services in useful, appealing and interactive ways to potential customers.
• Generate quote requests.
• Review RFPs, initiate internal evaluation of projects with site-based customer project manager for technical feasibility and cost assessment.
• Prepare proposals for internal review and approval prior sending to customers.
• Close opportunities.
• Negotiate MSA and CSAs.
• Initiate and participate in industry events.

Director, Sales and Business Development – Injectables

• Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for quality control and process control
• Runs standard and advanced analysis in-process, raw material, intermediate and final release samples
• Analyzes batches of drug substance and/or intermediates to be used in clinical or registration programs
• Handles potent materials per applicable procedures and training
• Performs qualitative tests or quantitative assays on samples using standard analytical equipment
• Responsible for training new chemists as needed
• Ensures laboratory productivity and turnaround goals are met

In-Process QC Analyst

• Performs laboratory tests to determine chemical and physical characteristics or composition of solid and liquid materials for such purposes as quality control, process control, consistently, and accurately.
• Displays ability to set up and follow procedures independently as directed.
• Maintains a high level of housekeeping.
• Displays initiative in completing training, and the ability to train others.
• Displays a high level of attention to detail.

In-Process QC Analyst – Nights

• Provides Quality Assurance related product leadership as it relates to planning and execution of customer projects.
• Responsible for the collaboration, review, and approval of GMP documents needed for products.
• Represents the highest level of GMP understanding and accomplishment and demonstrated technical knowledge as it relates to cGMP Operations.
• 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.
• Knowledgeable in regulations including, but not limited to, ICH Q7 – Q13, 21 CFR Parts 210, 211, 600, applicable USP requirements, and in cleanroom requirements as it applies to Annex 1.
• Represents QA for Quality related customer interactions for one or more products.
• Responsible for clear, direct, and appropriate communication in customer interactions.
• Provides Quality leadership and decision-making on cross-functional teams that include, but are not limited to, Operations, Process Engineering, Process Development, Analytical Development, Safety, and other Quality functions.
• Serve as process Quality Team representative on capital improvement projects.
• Provides process support including clinical development, process validation, technical transfer, and commercial activities.
• Collaborate, review, and approve all phase-appropriate product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation.
• Author and approve internal documentation including, but not limited to, training documents, work instructions, and Standard Operating Procedures (SOPs).
• Collaborate, review, and approve all levels of investigations (including major and critical investigations) and Corrective Actions Preventative Actions (CAPAs).
• Create, report, and communicate 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.
• Perform final product batch disposition.
• Assist in and represent Quality during internal and external audits and regulatory inspections. May lead audits and inspections as needed.
• Lead efforts that support CordenPharma initiatives and improvements. Knowledgeable in Operational Excellence.

Senior QA Product Specialist

• Oversee site-level treasury operations, ensuring disciplined cash execution in accordance with corporate treasury policies
• Partner with Finance Controller to develop, monitor, and validate short- and long-term liquidity forecasts, providing clear visibility into funding requirements and cash risks
• Provide dedicated cash management oversight for strategic construction projects aligned with Engineering and Steering Committee governance frameworks, ensuring alignment between approved CARs, project milestones, and cash requirements
• Coordinate site-level tax compliance activities in partnership with external Tax Advisors and Corporate Tax Team
• Oversee site lease accounting in accordance with IFRS 16/ASC 842, including identification, classification, and ongoing administration of lease arrangements
• Lead site level insurance management in partnership with Human Resources and Safety, Health, & Environmental (SHE) Teams
• Ensure alignment with corporate policies, accounting standards, and regulatory requirements across treasury, tax, leasing, insurance, and capital cash management activities