Manufacturing Technician

Manufacturing Technician

(Clinical Environment)

Ivyland, PA

We are growing and seeking a full time and permanent Manufacturing Technician (Clinical) to join our Team!

Lyophilization Technology, Inc. (LTI), established in 1992, is a unique Contract Development and Manufacturing Organization (CDMO) enjoying a leadership position in the health care and related industries.

The company conducts applied research, provides scientific services and technical support, and manufacturers clinical supplies for freeze dried pharmaceuticals, biologics, diagnostics, and biopharmaceuticals.

LTI is located in Ivyland, Bucks County, Pennsylvania. Current operation expansion is underway for 2023 completion.

Our opening for a Manufacturing Technician is an opportunity for a detail oriented, self-motivated, creative and energetic individual to join a dynamic, technology
oriented organization.

As a member of the scientific team, you will participate in the preparation of parenteral preparations for clients conducting toxicological and clinical trial studies.

This unique aseptic processing operation that includes containment capabilities focuses on preparing sterile lyophilized products for toxicology and clinical studies of
critical freeze dried products.

Collaborating with client project teams, you will be able to apply your skills and knowledge to the preparation of new and novel lyophilized health care products ranging from antibiotics to vaccines.

Manufacturing Technician position responsibilities:

Day-to-day operations in the GMP Manufacturing Area, including development and sterile product preparation.

Procure, and maintain inventory of materials and supplies

Maintain and support an aseptic operation, including cleaning, sanitization and environmental monitoring activities.

Preparation of sterile toxicology and clinical supply materials.

Be engaged in preparing sterile product, collaborating with other Manufacturing Technicians, supervisor and Project Director

Participate in batch preparation, fill, lyophilization, inspection and packaging activities,

Execute procedures for preparation and processing, completing batch documentation.

Process development and manufacturing techniques for processing, including sterile products that include cytotoxic, highly potent compounds and biologicals
using isolators.

Work with the supervisor and Safety Officer for sustaining proper conditions for containment

Compose and review Standard Operating Procedures,

Maintain containment equipment and execute proper procedures.

Equipment Qualification and Process Validation:

Execute validation studies, compile and evaluate data, Compose validation reports.

Follow all aspects of cGMP compliance for the Clinical Manufacturing Area including all its related elements such as facilities, equipment and documentation, training, reports and records.

Work with the Quality Assurance staff on procedures and documentation associated with production of GLP and cGMP supplies.

We are an Equal Opportunity Employer

We are NOT using search firms to fill this position.

Interested candidates, please submit your résumé along with a cover letter and three (3) professional references via the MEA.jobs website submission.

For additional information about Lyophilization Technology, Inc., Please visit our Website at: https://www.lyotechnology.com/

Requirements:

Seeking a fulfilling growth opportunity

Strong work ethic

Good mechanical aptitude and the ability to troubleshoot on technical and process related issues preferred

Highly organized with attention to detail for successfully satisfying diverse responsibilities

Ability to work in a dynamic environment and collaborate with a cross functional project team

Possess a positive attitude

Excellent written and verbal communication skills

Proficient in MS Windows 10 Pro and MS Office 365 products: Word, Excel, Access, and Outlook

Ability to routinely lift materials weighing approximately 20 pounds

Possess a valid Driver's License

Creative problem solving

Preferred Requirements:

1-3+ years of experience in a healthcare product, clinical or commercial manufacturing environment.

Experience in aseptic processing.

Knowledge of cGMP regulations.

Demonstrated hands-on ability to achieve results in a multi-product environment.

Ability to write investigations and SOPs as needed.

By applying your background, knowledge, and experience in our unique technology, within our internationally recognized organization, you will earn an excellent salary and comprehensive benefits which include tuition reimbursement, as well as opportunities for professional development and career growth.