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Upcoming Volunteer Opportunities

• Task Force: Cryopreservation of Cells for Use in Cell Therapies & Regenerative Medicine Manufacturing (new standard)

  Scope

  This is an introduction and best practices approach on how to prepare, cryopreserve, and recover cells, cell lines, and tissue for use in cell therapies and regenerative medicine manufacturing.

  This proposed American National Standard (ANS) was presented by Dr. Brian Hawkins, Scientific Applications Director at BioLife Solutions, Inc.
  The proposed standard is intended to: address the challenges associated with maintaining viable recovery and functionality of cellular therapies and tissue products; discuss the benefits and considerations of low-temperature biopreservation; outline Biopreservation Best Practices for users; and propose considerations for incorporating Biopreservation Best Practices into a GMP cell therapy product.

  Producer Interest stakeholders (ex- manufacturers, supply chains, employees of test labs or commercial labs, etc.), those involved in cellular therapies and tissue products, cryopreservation of cells are being sought

  Requirements:

  Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard.

  Deadline:

  The deadline to submit notification of interest in serving on the consensus body is September 28, 2018. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.

• Task Force: Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries (new standard).

  Scope

  This proposed American National Standard (ANS) was put forward by Mr. Martin Van Trieste, Immediate Past Chair at PDA. The proposed standard is intended to address the challenges organizations face when purchasing, procuring, or referencing where specific material or ingredient came from. This proposal also provides steps to make the responsible party more effective in preventing substandard or adulterated materials from entering the market and potentially harming patients.

  Producer Interest stakeholders (ex- manufacturers, those involved in supply chains, employees of test labs or commercial labs, etc.), Regulatory Interest (ex those representing federal, state, local, foreign, or other government entities), those involved with purchasing / procuring / sourcing are being sought.

  Requirements:

  Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard.

  Deadline:

  The deadline to submit notification of interest in serving on the consensus body is September 28, 2018. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.

• Instructor for PDA Education Courses

  PDA Education is looking for individuals who would like to teach either a lecture, hands-on or laboratory course on an innovative topic or a course in one of PDA's areas of specialty, including:

  • Aseptic Processing
  • Biotechnology
  • Combination Products
  • Environmental Monitoring
  • Filtration
  • Microbiology
  • Quality and Regulatory Affairs
  • Supply Chain
  • Training
  • Validation
  • Visual Inspection

  If you are interested in teaching or have an idea for a new course, please send a cover letter and resume to Karena Grigsby, Volunteer Coordinator, PDA.
• Author or Contribute to the PDA Journal of Pharmaceutical Science and Technology

  Manuscripts are accepted at any time and can include letters to the editor, commentaries, reviews, original research, and technology/applications (e.g., case studies).

  Learn more about being a PDA Journal of Pharmaceutical Science and Technology Author.

• Author: Technology Case Study

  The PDA Letter is looking for authors to write short case studies based on their experiences implementing new technologies into their operations. These could be in manufacturing, labwork, packaging, etc. We’re looking for 750-1000 word articles. We’re always looking for such authors so there is no deadline. Authors can be of any background and level of experience.

  Send inquiries to Karena Grigsby, Volunteer Coordinator, volunteer@pda.org.

• PDA Connect Community Leader: Management of Outsourced Operations

  Management of Outsourced Operations Interest Group looking for a new leader

  Mission Statement

  The Management on Outsourced Operations Interest Group will provide a platform for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities, and, serve as the liaison between RAQAB and follow-up of the PCMO Task Force.

  Scope

  • To monitor regulatory developments, guidance’s and standpoints regarding management of outsourced activities
  • To support the preparation of position papers, Points to Consider documents, or a Technical Report on outsourcing as well as submission of articles to the PDA Letter; which may evolve from IG Meetings
  • To proactively identify ways of ensuring a global approach for integration of ICH Q10 using ICH Q9, and principles of Quality Risk Management in managing outsourced activities
  • To provide input to scheduling and content of PDA conferences and TRI courses on outsourcing.

  The IG leader role is an important connection to PDA members at large. IG leaders are expected to keep abreast of developments in the IG area of interest and to promote frequent interaction with their membership. PDA Connect is an excellent tool for accomplishing this. IG Leaders also have networking opportunities with Regulatory and Quality Advisory Board (RAQAB) Members and other IG leaders as well as opportunities to host F2F meetings during PDA signature conferences. The ideal candidate will have experience or current job function working with outsourcing partners or in a CMO/CDO.

  Requirements

  • Active PDA Membership Required
  • Residing in the United States (optional)

  Time Commitment

  • Long-term volunteer opportunity: 3 years
  • The anticipated time commitment is about 15 minutes per day.

  Please send a CV highlighting your experience that match this request to Karena Grigsby, Volunteer Coordinator, volunteer@pda.org.

  Please note: If selected for this position, you will receive online community management training, and you will join a forum with PDA's other community coordinators where you can learn from each other’s' experience and brainstorm together.

• PDA Journal Editorial Board

  Scope

  PDA is establishing an all-volunteer Editorial Board for the PDA Journal of Science and Technology comprised of qualified experts with working knowledge of existing and/or emerging science and technologies important to PDA members. This expertise should include, but is not limited to, the following areas:  Aseptic Processing/Sterilization, Pharmaceutical and Biopharmaceutical Manufacturing Science, Supply Chain, Packaging Science, Drug Delivery, Pharmaceutical Microbiology, and Viral Clearance.

  Requirements

  • The selection process will favor members in good standing.
  • The Editorial Board will consist of volunteers with diverse backgrounds (i.e., region, organization type, demographic).
  • Editorial Board members are expected to commit for a two-year term, with the possibility of renewal for an additional two years. 
  • Editorial Board members will be expected to solicit articles on areas of their expertise, contribute articles and/or editorials themselves on occasion, recommend peer-reviewers when asked, serve as peer-reviewers, and assist with the initial screening of submitted manuscripts. Members will also be expected to contribute their ideas to the development of a strategic plan for the Journal.

  Time Commitment

  PDA will organize two meetings with the entire Editorial Board per year:

  • one via virtual conferencing tools, like "GoToMeeting" and;
  • the other, an in-person meeting either at a PDA event or at PDA's headquarters in Bethesda, Md. (travel expenses for volunteers will not be reimbursable).

  Please note: Activities should not demand more than three hours per month.

  Deadline

  Accepting applications until volunteer positions filled.

  If interested in this volunteer opportunity, please forward a resume/CV to volunteer@pda.org.

• Technical Translator: Spanish

  Scope

  PDA is looking to offer translation of technical reports and is recruiting member-volunteers with subject-matter expertise to serve as translators and as quality control checkers. While PDA is interested in translating into many languages relevant to our members, the Association is currently seeking volunteers fluent in technical Spanish and English.

  PDA is also seeking volunteers to serve on a Translation Review Committee who will review the translated technical report and compare it to the original English version for the purposes of determining its accuracy. These volunteers will receive recognition as contributors in the document, and one copy of the translated electronic technical report for their efforts.

  Time Commitment

  Volunteer translators must be willing to commit the appropriate amount of time necessary to complete a translation of a technical report within one to three months.

  Please note: Technical reports range from as few as thirty to as many as 100 pages (the typical report is about 60 pages.)

  Requirements

  • Fluent in both English and Spanish (or other language)
  • Active PDA Membership
  • Agree to PDA’s Confidentiality, Conflict of Interest and Copyright Agreements.

  Additional Information

  Volunteers will receive recognition as translators in the document, and a free copy of the original and translated electronic technical report for their efforts, assuming the final translation is accepted and published.

  Deadline

  Accepting applications until volunteer positions filled.

  If interested in this volunteer opportunity, please forward a resume/CV to volunteer@pda.org.