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    1 month ago

    Pittsburgh, United States HRT Solutions Full time

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Project Manager

2 months ago

Pittsburgh, United States Krystal Biotech, Inc. Full time
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 Project Manager to join our cross-functional team in Pittsburgh. The Project Manager will be responsible for managing a variety of facility, equipment, and business-related projects. They will also assist the upkeep of equipment and facilities, including planning or executing installation, validation / commissioning, and process improvements.

Primary Responsibilities:
  • Provide technical expertise for the planning, prioritization, and execution of projects supporting business goals
  • Ensure projects are completed to specification within an established timeframe and budget through oversight of short-term and long-term objectives
  • Build and collaborate with cross-functional teams. Track activities and prepare progress reports.
  • Support new product or technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
  • Apply process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity
  • Interact with external contractors and vendors to schedule qualified resources for activities as necessary
  • Coordinate activity schedules with internal departments to ensure staff and system availability
  • Review specifications for systems and equipment to understand proper usage to ensure business or process requirements are met
  • Investigating, documenting, and reporting all non-conformances in alignment with protocols and site CAPA plans
  • Reviewing all paperwork to ensure activities are documented according to the site's guidelines and SOPs
  • Resolving any issues in a quick and efficient manor
  • Remaining up to date on regulations and industry standards
  • Other duties as assigned
Experience and Skills Desired:
  • Bachelors' Degree in Life Sciences, Engineering, or related technical field
  • Relevant hands-on experience in an engineering setting, preferably within biotech/pharma industry
  • Direct experience within regulated environments (i.e., FDA, cGMP, OSHA, EPA, etc.) and strong knowledge of GMP and ICH requirements
  • Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup and validation, preferred
  • Project Engineering / Project Management background in a dynamic, cross-functional setting
  • Must be a self-starter and capable of working with minimal oversight
  • Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately
  • Excellent oral and written communication skills

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.