Manufacturing Production Analyst

Manufacturing Production 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. Combining long-term and short-term production readiness and analysis.

Include the following. Other duties may be assigned.

1. Manufacturing & Operational Analytics (Commercial + Development)

• 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

1. Development Program Analytics

• 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
• Quantify impact of delays on downstream manufacturing

1. Capacity Planning & SIOP Support

• Support SIOP by aligning demand forecasts with production capability
• Modeling trade-offs across commercial vs. development priorities
• Identify capacity gaps and debottlenecking opportunities

1. Financial & Cost Analytics (Operations-Facing)

• 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
• Quantify financial impact of deviations, rework, scrap and downtime delays or inefficiencies

1. Data Infrastructure & Reporting

• Collaborate with BI team to:
• Develop and maintain standardized reporting for Daily/weekly operational dashboards and Monthly Reporting Packages
• Integrate data from SAP, MES / LIMS, Smartsheets and other Scheduling tools to improve data quality and reduce reliance on manual Excel processes

1. Support Transformation Office with Analytics

• Drive analytics supporting Lean / Six Sigma initiatives:
• Root cause analysis (5-Whys, Pareto)
• KPI tracking for improvement programs
• Support governance forums (e.g., Summit 28, Tier meetings, SIOP, MBRs) with decision-grade analytics

Leadership & Budget Responsibilities

None.

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

• Bachelor's Degree in Engineering (Chemical, Biochemical, Industrial), Operations Research, Data Analytics, or related field. Advanced degree (MBA, MS) preferred
• Five years of progressive experience in Operations Analytics within a GMP-regulated environment (CDMO/Pharma preferred)
• Demonstrated ownership of end-to-end analytics frameworks (e.g., batch-level profitability, yield analysis, throughput optimization)
• Proven ability to translate operational data into actionable insights tied to revenue, EBITDA, and working capital
• Hands-on experience with SIOP, capacity planning, and production scheduling analytics
• Strong understanding of Cost Accounting in manufacturing environments (standard costing, variance analysis, absorption)
• Experience supporting executive-level reporting (MBR, board materials, KPI dashboards)

Language Skills

Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

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, diagram, 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 close vision 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.

• Excellent communication skills and the ability to manage multiple tasks simultaneously
• Understanding of accounting principles as they apply to organization and business matters
• Understanding the basics of manufacturing and key business processes
• Strong analytical and problem-solving skills. Able to do ad hoc reporting and reconciliations as requested
• Hands-on experience with an ERP (Enterprise Resource Planning) Mainframe System (i.e., SAP, JD Edward, Oracle)
• PC skills are required, including