Proposal Writer - CDMO , Sterile Drug Product

Alcami Corporation•Remote,

4d•Remote

About The Position

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. The Proposal Writer (Technical Evaluations Specialist) drives results in a fast-paced environment by assessing requests for proposals (RFPs) received from our Sales and Business Development team or customers. This role demonstrates technical and scientific expertise for assigned business units (focusing on Sterile Drug Product) to develop proposals, including associated costs. The Proposal Writer collaborates with Sales and Business Development, Project Management, Finance, Legal, and Operations to provide technical guidance to customers, which includes direct customer interface. This role demonstrates a high level of independence.

Requirements

Bachelor’s degree in a scientific or engineering field with 4+ years of industry experience.
Master’s degree or doctorate degree in scientific or engineering field with 2+ years of industry experience.
CDMO and sterile drug product experience required.
Knowledge of FDA regulations/ICH guidelines.
Knowledge of U.S. Drug Development process regulatory requirements for pharmaceutical industry.
Knowledge of activity costing, margins, and budgets.
Knowledge of scientific terminology and testing procedure requirements as related to area focus.
Excellent communication, interpersonal, presentation and organizational skills.
Excellent customer service orientation.
Excellent organizational skills, detail orientation and ability to effectively manage competing priorities.
Proficiency with Microsoft Office including Excel and Word.
Ability to gain proficiency working with a CRM. Prior CRM experience such as Salesforce.com preferred.
Demonstrated ability to understand the interdependencies of process chemistry, analytical development and manufacturing necessary to support specific assigned area(s).

Nice To Haves

Prior CRM experience such as Salesforce.com preferred.

Responsibilities

Performs technical evaluations of incoming RFPs and existing program extensions across Alcami capabilities for assigned business units (Sterile Drug Product) including proposed scope of work, costing, and budgets with limited guidance from Management.
Compilates technical evaluation into appropriate templates and proposal generation.
Assesses with Operations and recommends Alcami capabilities to meet customer requirements as part of technical evaluations.
Represents technical operations in front of customers in support of project acquisition with Sales & Business Development and Project Management.
Attends customer site visits and presentations for new opportunities.
Performs data entry into the applicable CRM system.
Performs assigned tasks carefully and on schedule per supervisor instructions.
Adheres to all company SOPs and policies.
Identifies opportunities for process improvements.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.