提案作家- CDMO，无菌药物产品

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.
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Job Summary
A 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. Technical Evaluations Specialists demonstrate technical and scientific expertise for assigned business units (focusing on Sterile Drug Product) to develop proposals, including associated costs. Technical Evaluations Specialists collaborate with Sales and Business Development, Project Management, Finance, Legal, and Operations to provide technical guidance to customers. This includes direct customer interface. Technical Evaluations Specialists demonstrate a high level of independence.
On-Site Expectations

• 100% remote position.

• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

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.

Qualifications

• 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.

• Strategic pricing experience preferred.

Knowledge, Skills, and Abilities

• 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).

Travel Expectations
· Up to 5% travel required.
Physical Demands and Work Environment
The physical demands and work environment characteristics 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 use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit.
Originally posted on Himalayas