Jennafer Lyons Email & Phone Number

Denmark

Hillerød Municipality, Capital Region Of Denmark, Denmark

Baar, Zug, Switzerland

Technical Product Lead for Biogen's two commercial Alzheimer's products (Aduhelm and Leqembi), as well as a late-stage molecule for Lupus (litifilimab). I sit on the strategic program team for each product representing the technical and manufacturing operations reporting lines. Responsibilities include defining lifecyle management strategy for each product from late-state clinical through commercial and post-licensure changes; establishment of Continuous Process Verification plans and ongoing… Show more Technical Product Lead for Biogen's two commercial Alzheimer's products (Aduhelm and Leqembi), as well as a late-stage molecule for Lupus (litifilimab). I sit on the strategic program team for each product representing the technical and manufacturing operations reporting lines. Responsibilities include defining lifecyle management strategy for each product from late-state clinical through commercial and post-licensure changes; establishment of Continuous Process Verification plans and ongoing monitoring of CPV throughout the product lifecycle; authoring and reviewing of regulatory submissions and queries, as well as oversight of implementation / completion of regulatory commitments impacting manufacturing; contributing author to the Annual Product Review (APR) and approval of the QOS; support of at-scale DS and Parenteral DP manufacturing including support for major deviations and GCCs; escalation point of contact between the project teams and SMEs via clear communication, collaborative cross-functional discussions across multiple time-zones; responsible for ensuring maintenance of the historic technical knowledge and documentation throughout the lifecycle of a product. Show less

Zug, Switzerland

Worked in the Global Manufacturing Sciences department supporting GMP late-stage and commercial Drug Product manufacturing processes at multiple contract manufacturing sites. I served as the technical subject matter expert for compounding, sterile filtration, and sterile liquid vial or syringe filling operations. I was the process SME for manufacturing investigations, change controls/ process improvements, Regulatory Agency inspections, documentation review / approval (SOPs, batch records… Show more Worked in the Global Manufacturing Sciences department supporting GMP late-stage and commercial Drug Product manufacturing processes at multiple contract manufacturing sites. I served as the technical subject matter expert for compounding, sterile filtration, and sterile liquid vial or syringe filling operations. I was the process SME for manufacturing investigations, change controls/ process improvements, Regulatory Agency inspections, documentation review / approval (SOPs, batch records, protocols, reports) and process performance monitoring / CPV. I contributed to Regulatory dossier submissions (MAA, BLA, post-licensure filings, etc) and regulatory agency responses. I was also the Technical Product Lead for our Interferon products (Avonex, Plegridy). Show less

Zug, Switzerland

Currently working in the External Manufacturing Sciences department supporting late-stage and commercial Drug Product manufacturing processes at multiple contract-manufacturing sites. I serve as a technical subject matter expert for compounding, sterile filtration, and sterile liquid vial or syringe filling operations. I am the technical process SME for manufacturing investigations, change controls, process improvements, Regulatory Agency inspections, documentation review / approval (SOPs… Show more Currently working in the External Manufacturing Sciences department supporting late-stage and commercial Drug Product manufacturing processes at multiple contract-manufacturing sites. I serve as a technical subject matter expert for compounding, sterile filtration, and sterile liquid vial or syringe filling operations. I am the technical process SME for manufacturing investigations, change controls, process improvements, Regulatory Agency inspections, documentation review / approval (SOPs, batch records, protocols, reports) and process performance monitoring / CPV. In addition I have project management roles for tech transfer, change controls and process improvements, and I contribute to BLA and post-liscensure filings. Show less

Cambridge, Ma

I supported downstream Drug Substance manufacturing operations for GMP clinical and commercial operations. I served as a project manager (tech transfer, process improvements, change control owners) as well as the technical subject matter expert for process investigations, change controls, Regulatory agency inspections, documentation (SOPs, batch records, reports) review, and process monitoring, etc. In addition, I contribute to INDs, BLAs, and post-licensure filing changes.

Andover, Ma

I worked in the Purification Process Development department primarily involved with two main areas: 1) development of chromatography based purification processes for primarily CHO based molecules - Phase I through commercial scale; liquid chromatography, high throughput screening, HPLC assays, SDS-PAGE, tech transfer activities, scale-down validation / qualification studies for chromatography processes (DOE robustness, virus removal / inactivation, resin cycling, product stability, impurity… Show more I worked in the Purification Process Development department primarily involved with two main areas: 1) development of chromatography based purification processes for primarily CHO based molecules - Phase I through commercial scale; liquid chromatography, high throughput screening, HPLC assays, SDS-PAGE, tech transfer activities, scale-down validation / qualification studies for chromatography processes (DOE robustness, virus removal / inactivation, resin cycling, product stability, impurity removal studies, etc), facilitator for Risk Assessment activities in support of late stage process development,and 2) support of multiple commercial manufacturing processes as a Subject Matter Expert for chromatography unit operations, providing written scientific / technical input for manufacturing investigations, process development and tech transfer of process improvements, written contribution to regulatory filings, technical support for health agency inspections, raw material changes / challenges; Show less

Andover, Ma

See the description under my Pfizer experience.

Supported chromatography step development for early phase CHO based processes including virus validation and resin lifetime studies;Supported process improvements for manufacturing an affinity resin (reduction of ligand leaching, improved coupling, improved capacity)Performed multiple assays (SEC and Affinity HPLC, SDSPAGE, Western Blot, BCA) in support of department

Westwood, Ma

Developed ELISA based assays for a panel of infectious diseases ranging from Hepatitis B to HIV for use with OPUS automated system. Purified Antibodies, coupled Abs to either beads or membranes for use in the assays; wrote custom programs for the OPUS systems; Behring was eventually bought by Dade in 1997 and the majority of the site was laid off. The company subsequently closed in 1999.

Bachelor Of Arts - Ba, Biochemistry, 3.0

Activities and Societies: Theater, orchestra, chorus, Resident Advisor, LGBTQ+ network, Tuxedo Junction (a cappella group),

High School