Position Overview

The Director, Portfolio Lead - Aerosol is responsible for owning the end-to-end aerosol program development and management for Peptilogics’ current and future assets. The successful candidate will have a unique opportunity to develop and expand upon a diversified technical skill set while making a positive contribution to the area of particle science and technology. Ideal candidates will be highly collaborative, have a deep understanding of materials science, strong communication skills, and a passion for identifying potential aerosolized product solutions.

Essential Functions

  • Provide expert advice on experimental methods for Aerosol testing to support new product development and sustaining activities
  • Develop, maintain, and monitor the necessary processes and documentation required to maintain compliance to GLP level standards
  • Ensure the necessary study plans, protocols, processes, and other documentation for studies for pharmaceutical partners that are intended for submission to a regulatory body are established, documented, implemented, maintained, and reported to GLP level standards
  • Act as a point of contact for quality processes during auditing of Aerosol laboratories by external & Internal parties, for conformance to GLP level standards when requested
  • Plan, perform and co-ordinate the aerosol testing of products, in conjunction with the product project groups and production
  • Present clear and accurate protocols and reports that present meaningful data to stakeholders
  • Drive the establishment of the aerosol portfolio program structure and processes from ideation to execution including tracking and measuring the achieved results via budgets evaluations and dashboards
  • Manage and align the funding process for aerosol portfolio across multiple functional/technical designs and/or timelines
  • Guide internal and external functional counterparts through all stages of planning and execution of program objectives, including directing and allocating resources, timing, etc., to assure program(s) completion
  • Conduct aerosol portfolio project reviews with leadership, partners, and other relevant stakeholder teams to assess, execute change, and reprioritize objectives to meet business needs and/or mitigate constraints
  • Participates in overall business planning in their program area(s) to ensure alignment to business objectives
  • Develops strategic and associated communications documents, including portfolio status reports
  • Effectively communicates program expectations to team members and stakeholders in a timely and clear fashion
  • Estimates the resources and participants needed to achieve program goals
  • Draft and submit budget proposals and recommend subsequent budget changes where necessary
  • Act as one of the company's representatives for Aerosol Sciences with external bodies
  • Work Safety – Ensures that all tasks and functions of position are always performed in a safe manner and that all procedures and requirements are properly followed to accomplish assigned tasks
  • Other duties as assigned

 

Required Qualifications and Skills

  • BS in Pharmacology, Biology, Chemistry, Microbiology, (MS Preferred)
  • 8+ years' experience in a laboratory environment preferably an aerosol / R&D laboratory
  • Skilled in current AS analytical instruments and techniques for pharmaceutical aerosol testing
  • Understanding of medical devices
  • Basic project management / supervisory experience
  • Working knowledge of cGXP guidelines and a strong understanding of regulatory guidelines and directives
  • Ability to translate lab-based ideas into a plan for commercialization
  • Experience of analytical validation and instrument qualification
  • Excellent judgement and decision-making capability with ability to apply critical and analytical thinking skills and manage complex/ambiguous situations
  • Exceptional interpersonal skills and influencing at all levels, including the capability to build strong relationships in a matrix organization
  • Mastery of process improvement techniques
  • High degree of detail orientation with strong organizational skills
  • Composure, positivity, flexibility, organizational skills, and time management ability necessary to succeed in a performance-driven environment
  • Ability to work well independently and without close supervision, keeping focused on short- and long-term objectives
  • Live near or willingness to travel to Pittsburgh, PA

Diversity & Inclusion: Our Foundation for Innovation

At Peptilogics, diversity, inclusion and equality are embedded in our DNA. Together, regardless of gender, race, ethnicity, national origin, age, sexual orientation or identity, education or disability, the Peptilogics team envisions a workplace where all employees feel valued and respected. We provide equal employment opportunities to all employees and applicants as we continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our team members. 

Peptilogics is committed to serving as a model of diversity and inclusion for the entire biotech and biopharmaceutical industry and to maintaining an inclusive environment with equitable treatment for all. It fuels our innovation, reinforces our vision, and more closely connects us to the communities we serve.

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