Proposal Writer – CDMO, Sterile Drug Product

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🔥 1 minute ago

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Logo of Alcami Corporation

Alcami Corporation

501 - 1000 employees

Founded 1979

🏥 Healthcare

🏭 Manufacturing

📋 Compliance

Healthcare • Manufacturing • Compliance

Alcami Corporation is a leading provider of integrated solutions for privacy management, risk management, and compliance. The company offers a comprehensive platform that enables organizations to streamline consent and preference management, automate third-party management, and govern data and AI across the lifecycle. With a strong focus on regulatory solutions, Alcami Corporation supports businesses in navigating privacy laws like GDPR and ensures responsible data use through its innovative tools and training resources.

📋 Description

• Assess requests for proposals (RFPs) from Sales and Business Development teams or customers • Perform technical evaluations of incoming RFPs and existing program extensions for Sterile Drug Product capabilities • Develop proposed scopes of work, costing, and budgets with limited management guidance • Compile technical evaluations into appropriate templates and generate proposals • Assess customer requirements with Operations and recommend Alcami capabilities • Represent technical operations to customers in support of project acquisition • Collaborate with Sales & Business Development, Project Management, Finance, Legal, and Operations • Attend customer site visits and presentations for new opportunities • Enter data into the applicable CRM system • Identify process improvement opportunities • Complete work on schedule and comply with SOPs, policies, cGMP, and training requirements

🎯 Requirements

• Bachelor’s degree in a scientific or engineering field with 4+ years of industry experience • Master’s degree or doctorate degree in a scientific or engineering field with 2+ years of industry experience • CDMO and sterile drug product experience required • Knowledge of FDA regulations and ICH guidelines • Knowledge of U.S. drug development process regulatory requirements for the pharmaceutical industry • Knowledge of activity costing, margins, and budgets • Knowledge of scientific terminology and testing procedure requirements • Excellent communication, interpersonal, presentation, and organizational skills • Excellent customer service orientation • Ability to manage competing priorities and maintain attention to detail • Proficiency with Microsoft Office, including Excel and Word • Ability to gain proficiency working with a CRM • Ability to understand interdependencies of process chemistry, analytical development, and manufacturing • Up to 5% travel required

🏖️ Benefits

• Medical, dental, vision and prescription coverage • Life insurance • LTD and STD coverage • 401(k) with match and immediate vesting • Tuition reimbursement / student loan forgiveness • Professional growth • Competitive salary • Exceptional benefits package

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