Shalaka Patel

Director, Precision Medicine and Companion Diagnostics, Bristol-Myers Squibb

Role: Director, Precision Medicine and Companion Diagnostics, Bristol-myers Squibb at Bristol Myers Squibb
Location: Greenwich, CT, US
LinkedIn followers: 500 followers

About Shalaka Patel

Lead Precision Medicine and Companion Diagnostic projects linked to strategic pharmaceutical business needs.• Lead large teams and projects linked to strategic business needs in the Life Sciences Diagnostic industry from early concept / design phase through regulatory clearance to market launch.Areas of expertise include:• Leadership: Lead Precision Medicine/Companion Diagnostic projects, large R&D and cross-functional project teams. • Program/Project Management: Execute projects/programs by managing teams, overseeing budgets, managing initiation/collaboration CDx agreements, determining resource requirements, managing risk and timelines. • Quality/Regulatory expertise: Plan/conduct validation and clinical activities for 510(k) and PMA submissions for IVD products, adhere to Quality Management Systems and ISO13485 standards, and performing internal audits. Develop internal standards, documentation and training procedures.• Sales/Commercial support: Support strategic sales efforts by scientific technical presentations, handle customer trainings, conduct beta testing on new or modified products; trouble shoot assay and software related issues; write white papers. Served as key technical point of contact for customer assistance and relationships with KOLs in the field. • Technical expertise: Companion diagnostic assay development in oncology, Red cell and HLA diagnostic assays; NGS and Sanger sequencing; Assay Automation on Janus, Tecan and Biomek platforms; Protein Biochemistry; Antibody Assays

Experience

Director, Precision Medicine and Companion Diagnostics, Bristol-myers Squibb
Bristol Myers Squibb
Oct 2021 — Present

Education

St. Xavier's College
Bachelor of Science (B.Sc.), Lifesciences/Biochemistry
The Ohio State University
PhD, Molecular and Cellular Biology
1999 — 2005
MS University
Master of Science (MSc), Biotechnology

Skills

Fda - 510(K) Submissions
Genetics
Research
Biochemistry
Cell Biology
Pcr: Multiplex, Qpcr
Molecular Biology
Lifesciences
Life Sciences
Transplantation, Transfusion Immunology
Polymerase Chain Reaction (Pcr)
Microbiology
Sequencing - Sanger and Ngs
Biotechnology
Protein Purification
Pcr
Immunology
Assay Development

Contact information

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•••••@bms.com
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Current company

Bristol Myers Squibb

Pharmaceutical Manufacturing · 39K employees · Lawrence Township, New Jersey, United States

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome. Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients. Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do. Review our Social Media Community Guidelines at: https://www.bms.com/social-media-community-guidelines.html

bms.com

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About Shalaka Patel

Experience

Director, Precision Medicine and Companion Diagnostics, Bristol-myers Squibb

Education

St. Xavier's College

The Ohio State University

MS University

Skills

Find verified contacts for anyone on LinkedIn