Job Description

About Krystal Bio:  

At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

 

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Packaging / Manufacturing Support Technician to support our commercial manufacturing facility in the South Side.  The Technician will work closely with the manufacturing team to uphold quality standards, follow strict procedures, and contribute to the smooth operation of all manufacturing processes.

Primary Responsibilities:

• Execute packaging and labeling operations for gene therapy products in accordance with GMP and regulatory standards
• Operate, clean, and maintain packaging equipment and environments in ISO-classified areas
• Perform in-process inspections and label verifications to ensure accuracy and compliance with product specifications
• Collaborate with Quality and Manufacturing teams to resolve discrepancies and support batch record documentation
• Support inventory control of packaging components and ensure traceability of serialized materials
• Adhere strictly to SOPs and cGMP practices to ensure product integrity and patient safety
• Support the final steps in the manufacturing process, and become a subject matter expert in our packaging and labeling equipment
• Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner
• Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials
• Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules
• Participate in training sessions and meetings to stay updated on the latest industry standards, regulations, and best practices
• Assist with movement of materials; work with EHS/Materials Teams for collection and dispensing of biohazardous waste
• Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends
• Perform other tasks, as assigned

Requirements and Preferred Qualifications:

• High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus
• In lieu of direct experience, bachelor’s degrees in applicable fields such as life sciences or engineering will be considered
• Experience with packaging, labeling, or following SOPs in a regulated setting (GMP, ISO) is highly preferred
• Ability to follow detailed instructions and maintain accurate documentation
• Excellent attention to detail, organization skills, and the ability to prioritize and multitask effectively in a fast-paced environment
• Demonstrated commitment to safety protocols and adherence to standard operating procedures
• Excellent communication and the ability to work well both independently and as part of a team
• Physical stamina and the ability to stand, bend, and lift heavy objects when necessary
• Flexibility to work shifts, including evenings, weekends, and holidays as required.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc.  will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc. 

Job Tags

Full time, Shift work, Afternoon shift,

Similar Jobs