PDA Metro Chapter: ATMP Interest Group In-Person Session and Vendor Night

Featured Presenters

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  Michael Blackton, MBA

  Elektrofi

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  Michael Blackton, MBA

  Elektrofi

  A member of PDA since approximately 1996, he is currently the SVP Technical Operations at Elektrofi. Prior to joining Elektrofi, Michael had roles in Quality, Operations, and Manufacturing over a career spanning 30 years with experience in monoclonal antibodies, small molecules, medical devices, and advanced therapies. Prior to his role at Elektrofi, Michael served as SVP of Cell Therapy Manufacturing at Nurix where he was Product Team Lead for cell therapy assets. Prior to Nurix, Michael was Global Head of Quality at Adaptimmune after spending 12 years working at Eli Lilly where his recent role was AVP Facilitities and Maintenance for Eli Lilly’s locations in New York and New Jersey.  Prior to Eli Lilly, Michael worked at Millennium Pharmaceuticals and Biomarin. Michael started his biotech career at IDEC Pharmaceuticals (Now Biogen) where he developed downstream processing methodologies for Rituxan.  Michael is active in the Parenteral Drug Association where he is a past Board Member and the immediate past chair and co-founder of the ATMP Advisory Board, co-founder of the ATMP Interest Group, a past member of the Biopharmaceutical Advisory Board, and co-contributor to several PDA Technical Reports dealing with lifecycle, steam in place, cell therapy, and oral solid dosage forms.

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  Rebecca D. Jordan

  Associate Director, Global Cell Therapy Sterility Assurance Lead, Bristol Myers Squibb (BMS)

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  Rebecca D. Jordan

  Bristol Myers Squibb (BMS)

  Rebecca Jordan is the PDA Interest Group lead for ATMPs. She is also an Associate Director, serving as the Global Sterility Assurance Lead for the BMS Cell Therapy Franchise. She oversees all things contamination control in manufacturing facilities spanning across the Globe. Rebecca has over 15 years’ experience in industry, with the past 6 in the Cell Therapy space. She has supported both large and small manufacturing sites, new facility design and start-up, and global regulatory interactions. She has experience with a diverse product portfolio spanning everything from phase I INDs, veterinary, controlled substance, to commercial approvals of parenteral and CAR T medicines. She is a skilled investigator with a curious mind which has led to engaging diverse endeavors throughout her career. Rebecca holds a B.S. in Biology from Fitchburg State University. Outside of work, Rebecca is a military spouse, so she’s had to relocate her career and family across 4 states so far, including a giant tortoise that has been in her family for 23 years.
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  Luciana Mansolelli

  Janssen Advanced Therapies Regulatory Compliance Head, Janssen Pharmaceuticals

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  Luciana Mansolelli

  Janssen Pharmaceuticals

  Over 27 years of leadership and experience in the development, manufacturing, quality, and strategy.  Demonstrated leadership in cGxP strategy setting for new and existing operations and facilities and global organizations. Contributor to industry councils and standards.  Facilitation of strategic goals setting utilizing strategic analysis and thinking tools.

  Luciana is a Pharm D and has MBA in Innovation and Strategy.

  Currently Luciana serves as Head of Large Molecules and Advanced Therapies for J&J Innovative Medicines, prior to that she has held roles in corporate Compliance, Quality and Manufacturing Sciences and Technologies for Novartis Pharmaceuticals Corporation in Brazil and since 2011 in the US.

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  Jennifer Metch

  Plant Microbiologist, Janssen CAR-T

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  Jennifer Metch

  Plant Microbiologist, Janssen CAR-T

  Jennifer is the Plant Microbiologist within the Janssen CAR-T Advanced Therapies Supply Chain and has been with Johnson & Johnson for 26 years. Her areas of focus include collaboration with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products, define specific aseptic techniques to be performed for crucial process steps and provide input to processing operations, ensure microbiological control strategy is consistent with cGMP and Janssen requirements , design, maintain and deliver aseptic technique and microbiology awareness training program, maintain, re-evaluate and communicate KPIs to site environmental monitoring program, support process microbiological investigations, identify risks and opportunities in relation to contamination control on the manufacturing floor and drive follow-up initiatives for improvement in cooperation with operators, QC and operations management. Jennifer has a B.S in Biology from Stockton University.