Associate / Manager – CMC Regulatory and IMP Manufacturing Operations

Initial Therapeutics, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 61,000 - 143,000; Full time

Job summary

An established industry player is seeking a detail-oriented Associate/Manager for CMC Regulatory and IMP Manufacturing Operations. This hybrid role involves supporting regulatory operations, managing change control, and overseeing document lifecycle management for innovative diagnostic products. The ideal candidate will have a scientific background, strong communication skills, and the ability to thrive in a fast-paced environment. Join a global leader in healthcare and contribute to life-changing medicines while enjoying a comprehensive benefits package and opportunities for professional growth.

Benefits

Company-sponsored 401(k)

Pension

Vacation Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Life Insurance

Employee Assistance Program

Fitness Benefits

Employee Clubs and Activities

Qualifications

• 1+ years in pharmaceutical development or CMC regulatory.
• Bachelor's degree in a scientific discipline is required.

Responsibilities

• Manage CMC regulatory operations and document lifecycle management.
• Coordinate regulatory submission timelines and manage documents.

Skills

Organizational Skills

Communication Skills

Technical Writing

Project Management

MS Office

Education

Bachelor’s degree in a scientific discipline

Tools

Regulatory Information Management (RIM) system

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities:

The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within IMP manufacturing operations. This position supports Lilly/Avid diagnostic radiopharmaceutical products globally.

• Support CMC change management, including change control issuing and assessments, as well as task management to ensure compliance with quality management systems
• CMC regulatory operations (e.g., coordinate regulatory submission timelines, manage regulatory documents, prepare content plans for regulatory submissions, and maintain submission information according to the Regulatory Information Management (RIM) system)
• Manage the preparation, review, and submission of global CMC regulatory dossiers and information request responses according to CMC regulatory strategies
• Author, revise, and/or review technical documentation including but not limited to testing protocols, technical reports, and standard operating procedures
• Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans
• Support the establishment and maintenance of infrastructure tools, procedures, and systems for CMC regulatory and CMC development
• Keep current with global regulatory guidelines applicable to CMC
• Perform other duties as assigned

Basic Requirements:

• Bachelor’s degree in a scientific discipline
• Minimum of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory, project management, and/or related field

Additional Skills/Preferences:

• Organized and detail-oriented
• Strong communication skills with ability to work within global multi-disciplinary teams
• Excellent technical writing skills
• Ability to plan, prioritize, and handle multiple tasks concurrently
• Ability to independently complete assigned workload with minimum supervision
• Ability to adapt to change and work in a fast-paced environment
• Strong MS Office skills

Additional Information:

• Must be willing and able to travel within the USA and worldwide 10% of time

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $61,500 - $143,000.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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