Posts Tagged Pharma
Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience. If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.
Regulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.
Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation, running clinical trials, working with clinicians and medical centers.
Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.
Manufacturing Engineer – San Jose, CA
Requires 8+ years of experience in medical device manufacturing.
Director of Manufacturing Automation – San Jose, CA
This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.
Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.
Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome. BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.
Director of Pilot Manufacturing – San Jose, CA
Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing. This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.
Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on April 24, 2015
Healthcare industry is poised to go through impressive transformation, in the coming decade. What some experts have dubbed a 3D transformation, changes in life sciences are happening through massive changes in Diagnostics, Digital Devices, and Data.
Consider this. TiEcon, the largest entrepreneurship conference, focused for several years on computing, storage, hardware, software, firmware, semi conductors, gaming and mobile technologies. HealthTech was not the focus at TiEcon. But HeathTech has recently emerged as one of the hottest areas to invest. Besides offering a special healthcare focused track, on day 2, May 16th, healthtech is integrally woven in most of the other tracks, at TiEcon 2015. Technology has impacted all areas of our lives such that no entrepreneur could look at any industry as a silo. To register go to https://www.123signup.com/register?id=ygszb&ref=4182698 to get a $100 discount on the two-day conference at the non-member rate. When prompted, enter the promo code VOL500 at checkout:
In fact, most of the disruptive innovation is happening on the boundaries of disciplines. This is most pertinent in life science, hospitals and healthcare, healthtech, biotech, pharma, drug development, medtech, digital health, mobile health, wearables space. Every new intersection point between health and an emerging technology, brings its own terminology. Collectively, the aim is to positively transform the quality of lives of healthy and sick people. So how is life science focus woven across several tracks at TiEcon?
John Kapoor, a serial entrepreneur, who is number 577 on Forbes Billionaire List, is going to give a grand keynote address on day 2, Saturday. Kapoor, whose net worth is estimated at $3.5B, has founded and guided two pharmaceutical companies, Insys Therapeutics and Akorn Pharmaceuticals and led them to exceptional success. Pharmaceutical industry is slowly but surely changing to innovate faster, cheaper, more cost efficient process of drug development. Here is link to my recent blog on novel approaches to drug development http://bit.ly/1xzpdFx .
Here is another interesting keynote to watch out for. After helping coin the term, “Data Scientist”, while still in the academia, D. J. Patil did some initial work on deciphering the complexity of the weather patterns and impact of bioweapons proliferation in Central Asia. Here is link to my blog on Patil in 2013 http://bit.ly/YYyOxd . After stints in eBay, PayPal and LinkedIn, Patil was appointed by President Obama, as Chief Data Scientist at the White House. Among other responsibilities, Patil will work on the Administration’s Precision Medicine Initiative, focusing on utilizing advances in data to enable clinicians select most effective treatments. Here IBM’s Watson, an artificial intelligence system with access to millions and millions of pages of structured and unstructured data, to help in efficient diagnosis and suggest possible avenues for treatment, deserves special mention. Here is my link to Dave Farucci’s keynote at TiEcon, several years ago http://bit.ly/JOZmwH .
Besides the keynotes and healthcare representation on panels in other tracks, Day 2 focused Healthcare track panels will address such varied topics as role of “Medical Devices in a Changing Landscape” and “Trials and Tribulations of Adopting Technology in Hospitals”. Eminent speakers include, MD and CEO at Good Samaritan Hospital, Paul Beaupre; Anupam Pathak, Founder & CEO of Lift Labs, acquired by Google X, Brett Knappe, Senior Director of Strategy at Medtronic; Satnam Alag, VP, Software, Illumina; and Darius Naigamwalla, President at Campbell Alliance. Representation from technology rich companies such as IBM, GE, Google X, and Tibco, in discussions on healthcare, along with medtech and big pharma companies like Medtronic, J&J, 23&me, Illumina and Genentech AND representation from healthcare providers like Good Sam, will make for very rich dialogue. Register for TiEcon at https://www.123signup.com/register?id=ygszb&ref=4182698 to get a $100 discount on the two-day conference at the non-member rate. When prompted, enter the promo code VOL500 at checkout:
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 20, 2014
For the healthcare sector, JPM conference is the largest and most important event of the year. Technology innovators and life science professionals come together with the business analysts and investors and significantly more transpires outside the halls of the Westin hotel and presentations rooms, then what goes on inside. Inside, the companies begin their short presentations with disclaimers that their presentations will include forward looking statements and reality can be different. The companies give a quick overview of how they met the goals, objectives, and milestones they had envisioned or how and why they failed to meet them. The companies go on to succinctly talk about their goals, objectives and milestones for the year ahead. They share about new technologies, products, or drugs in the pipeline, the kind of return shareholders can expect, and make a case for why they present a great investment opportunity.
Outside the conference halls, market opportunities are discussed, new product or technologies are pitched, licensing contracts are signed, and deals are done as suited professionals fill up SF hotel lobbies, coffee houses, and diners. The networking does not stop in the evenings. Instead, it picks up. Various receptions hosted by law houses, life science companies, and investment firms at hotel penthouses and art galleries, offer opportunities to mingle and get to know people, in a less formal and more personal way. As alcohol freely flows and finger food and attractive dessert choices loosen everyone, professionals find more ways to make deals. In my next few reports, I will share more details from JPM conference and One Med Forum events. But overall mood this year was positive and companies had less to apologize for. Large pharma companies and smaller biotech and device companies are mostly done dealing with most dire recession challenges that hit the life science industry most deeply; nearly dried out funding sources, stagnated hiring, patent cliffs and lackluster period of growth that significantly lowered earnings.
Biopharma sector has enjoyed an incredibly good year, with 76.25% increase in value for the year, according to Bio World Blue Chip Index. Funding has also begun to flow. According to Bioworld Snapshots, the amount of capital raised by global private biotech companies was $4 B in 2013, up 4% on the total raised in 2012. Almost $1.5 B was raised in 4th quarter of 2013, a huge 55% more than $975 million raised in the third quarter of 2013. Biotechs also closed many venture rounds in Q4, 2013. And there was a flurry of activity in the IPO market, with a number of IPOs with 2X the offering price. So the good news is not just the number of IPOs, but their price, which has gone up 119% and their market cap which is up 236%.
But it will take a while for money to trickle down and spread more widely. And many other challenges remain. For instance, at 45 percent of the global R&D spend, although US still tops investment in life sciences, the amount has dropped 51% since 2007. Meanwhile the cost of developing drugs continues to rise. As one of the most scientifically and technologically advanced industries, life science sector still faces major challenges including stringent and constantly changing regulatory standards, rising R&D costs, and shorter market cycles. Additionally, there are increasing cost pressures, a need to streamline business operations, and increasingly higher expectations from patients, doctors, payers and so on. The environment at JPM was one of optimism, even exuberance, but it was also mingled with caution. In my following posts, I will include highlights from various keynotes and some company presentations.