Process Engineer - Proposal Focus

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

Evaluate incoming Requests for Proposals (RFPs) for feasibility, parse those RFPs by task, generate pricing for each task set, and then compile a draft quotation to be reviewed by Sales & Marketing.

All work is done in coordination with input from the Project Management Organization, Sales & Marketing, Manufacturing, Procurement, R&D, Scheduling & Planning, Engineering, Facilities, and the potential Client.

Ensure the proposal is viable at the proposed price, considering process chemistry, analytical chemistry, engineering, capital requirements, scheduling, raw material costs, time in plant, product release, and stability.

Also responsible for analyzing and improving the current processes involved with quotation generation, including developing calculation spreadsheets, developing tracking tools, etc.

Responsible for campaign planning by modeling different manufacturing cases (e.g., batch size, batch strategy, equipment) per Sales and Customer request. Also responsible for managing customer comments on proposals and proposal revisions.

Responsible for performing timeline assessments (i.e., ensuring plant equipment is available in the timeline provided in the proposal) for new RFPs and communicating capacity information to SIOP.

Performs costing for Work Orders (WOs), Change Orders (COs), and add-on campaigns for existing projects as requested by the project manager. This includes managing the agreement of scope between members of the technical team.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Perform cost assessments for RFPs, WO/CO, and add-on campaigns. Generate quotations and evaluation reports, ensuring that proposals are generated on time
• Evaluate capacity availability for new RFPs and new campaigns. Devise and evaluate alternative production strategies to align with equipment availability
• Document and justify production strategy and assumptions to Sales/Marketing and Site Leadership
• Exercise judgement in the RFP assessments and understand technical requirements as they apply to the Corden Colorado sites
• Work closely with Sales and Marketing, site technical and operational SMEs, and site leadership to provide evaluations and proposals including pricing spreadsheets, schedules, and capacity analyses
• Interface with potential clients, seeking clarification on scope of RFPs, technical details where necessary
• Provide prompt responses to customer informational requests
• Ensure all work is accurate and well-documented. Coordinate with potential customers, sales, and internal departments on assessment, identification, proposal, and implementation of new business projects
• Make technical recommendations for flexible management of assets to anticipate and respond to business changes
• Meet with managers and site leadership to discuss progress of quotes
• Identify opportunities to improve the proposal processes and devise plans to implement these changes
• Maintain site and corporate database and tracking tool of agreements and key dates
• Create business processes that improve quotation generation by better capturing the project costs, identifying risks of new processes, and improving the RFP turnaround time

LEADERSHIP & BUDGET RESPONSIBILITIES

Provide input to the Technical Project Management Organization toward completion of goals in a timely and complete manner. Work cross-functionally with sources of input to ensure complete responses.

No budgetary work required.

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

A Bachelor's Degree (BS) in Chemistry or Chemical Engineering, with 5 years of direct experience in Pharma API development, including experience with manufacturing environments. Previous experience in analytical development and knowledge of pharmaceutical regulatory requirements is a big plus.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, 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 develop and optimize mathematical methods that input to the proposal process. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. 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 frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance vision, depth perception, and 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, low levels of toxic or caustic chemicals, outside weather conditions, and vibration. The noise level in the work environment is usually moderate.

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.

• Effective in prioritizing workload
• Excellent internal and external customer service skills
• Excellent written, oral, and interpersonal communication skills
• Ability to write technical documents, business correspondence, and proposals
• Working knowledge of process chemistry, analytical procedures, and manufacturing processes
• Ability to read, analyze, and interpret business documents and technical procedures
• Ability to effectively present information and respond to questions from groups of managers, clients, and customers
• Computer skills with intermediate ability to use Microsoft Office Suite and Salesforce
• Strong process, implementation, and follow-up skills
• Good facilitation skills and ability to interact with colleagues from all levels of the organization
• Project management skills and ability to completely follow through tasks and projects to completion
• Ability to forecast work, identify potential conflicts, and develop and communicate potential solutions
• Ability to understand and implement company policies and practices, including regulatory compliance
• High level of attention to detail and ability to identify errors or changes needed to take corrective action to rectify
• Understanding of documentation needs and ability to maintain documentation systems in a timely and accurate manner

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 on September 30, 2025