New Directors of Process Development and Regulatory Compliance Join Consultancy
HAYWARD, Calif.–(BUSINESS WIRE)–Pharmatech Associates announce the addition of two new directors to executive level positions. Dr. Mihaela Simianu, Ph.D., joins the company as Director of Regulatory Compliance and Mr. Randy Henrickson joins the company as Director of Product and Process Development.
“Dr. Simianu’s deep technical knowledge and experience within complex compliance frameworks embodies Pharmatech’s commitment to compliance through science”
Dr. Simianu brings leadership, knowledge and experience in the Regulated Life Sciences industry from a career spanning over two decades. She is a long time member of the Parenteral Drug Association (PDA) and serves on the task force for PAC iAM (Post Approval Changes Innovation for Access to Medicines). She was a speaker and member of planning committees for conferences on injectable drugs and biologics topics. Previously, Simianu was Amgen’s Executive Director of Parenteral Product and Process Development in Thousand Oaks, Calif., and worked at Eli Lilly’s Research Laboratories (Indianapolis) and led global Manufacturing Science and Technology groups in various senior roles. She holds a Ph.D. from Marquette University and completed post-graduate work as a research fellow at the University of Nebraska-Lincoln.
“Dr. Simianu’s deep technical knowledge and experience within complex compliance frameworks embodies Pharmatech’s commitment to compliance through science,” said Bikash Chatterjee, President and Chief Scientific Officer, Pharmatech Associates.
Mr. Henrickson, a recognized leader in the field of process and product design for both pharmaceuticals and medical devices, will be adding his expert knowledge to the seasoned Pharmatech professional team currently encompassing product development, compliance, regulatory strategy, and validation. With over 20 years of experience in the biopharmaceutical industry he brings direct experience in the areas of product and process development, technology transfer, and operational management. Henrickson’s career spans multiple post-approval process optimizations for bio-similars and vaccine projects and delivering Phase I-III support for active Clinical Studies. Previously, he was senior Vice President and site head for KBI Biopharma’s Boulder, Colorado facility.
“Pharmatech Associates is extremely pleased to welcome both Mihaela and Randy to our team of professional consultants, as part of our continuing commitment to serve our clients in the regulated life sciences industry,” said Warren Baker, Chief Executive Officer, Pharmatech Associates. “Each brings outstanding talent, a wealth of leadership and strong executive experience that we intend to put to use in resolving product development, regulatory compliance and the quality issues confronting our clients.”
About Pharmatech Associates
Pharmatech Associates provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise that are necessary throughout the complete product development lifecycle: Product and Process Development, Compliance, Regulatory, and Validation. Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area.
SIPR for Pharmatech
Judy Curtis, + 1 650-274-1509
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