GMP Production Team Lead

Clinigen Group; Malvern (Chester County); On-site; USD 65,000 - 90,000; Full time

Job summary

Clinigen in Malvern, PA is seeking a Production Team Lead to head the packaging team, coordinate daily tasks, and ensure accurate labeling and documentation of clinical trial material.

Requirements include a High School Diploma or GED and at least 6 months in a related setting, with packaging experience and familiarity with SOPs, cGMP, or GDP preferred. This on-site role demands 5 days per week presence.

Qualifications

• High School Diploma or GED required.
• 6 months experience in an office setting or medical field preferred.
• 6 months packaging experience at Clinigen preferred.
• Experience with SOPs, cGMP, or GDP is preferred.

Responsibilities

• Lead and coordinate the day-to-day tasks of the packaging team.
• Share knowledge and information related to packaging tasks.
• Serve as subject matter expert for the CEMS inventory system.
• Act as SME on primary packaging operations including machine setup and troubleshooting.
• Make proactive recommendations to improve quality and efficiency.
• Train new packaging employees with supervisor mentorship.
• Perform Packaging Specialist tasks alongside team members.
• Provide support to the direct supervisor as needed.
• Suggest process improvements and be a knowledge resource.

Skills

Packaging operations

Team leadership

Documentation

Education

High School Diploma or GED

Tools

CEMS inventory system

Job description

About Clinigen:

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

The primary purpose of the Production Team Lead is to lead the packaging team to package, label and accurately document the creation of clinical trial material.

This position requires on-site presence 5 days/week.

To be successful in this role you should have:

• High School Diploma or GED required
• 6 months experience working within an office setting or medical field preferred.
• 6 months prior Clinigen packaging experience preferred.
• Preferred experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP)

Your role at Clinigen:

• Acts as lead to the packaging team by coordinating and directingtheday-to-day tasks of the packaging team.
• Supports the Packaging team bysharingknowledge, skills and informationrelated to the tasks and requirements of the position.
• Acts as a subject matter expert for the CEMS inventory system
• Acts as a subject matter expert on all primary packaging operations, including machine set ups and trouble shooting.
• Makesproactive recommendations and present/offer solutions to improve quality and work efficiently.
• Trains newpackaging employees on packaging processes, procedures, and works with supervisor to ensure a mentor is assigned.
• Performs all Packaging Specialist tasks and duties alongside other team members.
• Provides support to their direct supervisor as needed.
• Suggests improvements to processes and is a knowledge resource for other team members

We’re excited about you if you have:

• Ability to work independently or within a team.
• Detail oriented to produce timely and accurate work.
• Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast-paced environment.
• Maintain a high regard for confidentiality while dealing with all clients, proprietary, and pharmaceutical related information.
• Excellent oral, written, and interpersonal communication skills with active listening ability
• Excellent time management skills to prioritize work and meet deadlines.
• Ability to develop effective working relationships with associates at all levels to influence others and foster a cooperative work environment across the organization.

While at Clinigen, you’ll enjoy:

The culture.

Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.

The transparency with leadership.

All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.

The benefits.

We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

EEO.

Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.