Posts Tagged biologics

JOBS: May, 2019


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.

Job Search Human Resources Recruitment Career ConceptRegulatory 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.

Requirements
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.

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Innovative Deal Structures in Medtech Financing (2015 WSGR Med Device Conference)


WSGR 2015 Medical Device conference, focused on understanding the challenges facing the medical device industry, and highlighting the emerging strategies to navigate the new and complex world of medtech. Eminent team of panelists discussed “innovative deal structures” at WSGR medtech conference, in San Francisco.  The panel was moderated by Scott Murano, Partner at WSGR and panelists included Justin Klein with New Enterprise Associates, Evan Norton, Divisional VP at Venture Investments, Abbott Ventures and Mir Imran, Chairman and CEO at InCube Labs.  The panel shared insights from their recent experiences with corporate partnering transactions.

Justin Klein at NEA, with $3.1B fund, focuses on medical device, healthcare technology and biopharmaceutical investments.  Recently NEA funded three medical device companies, all of them in Atrial Fibrillation space.  “Scarcity of assets in AFib category positioned AFib as a very attractive category”, said Klein.  NEA was a strategic investor alongside others, including Abbott Ventures, in its more recent financing of Sunnyvale based VytronUS, with a proprietary cardiac imaging and ablation system to treat atrial fibrillation and other arrhythmias.  Although NEA funds companies from early stage, VytronUS is couple of years away from commercialization, said Klein.  NEA looks for interesting opportunities to syndicate with a broader variety of partners.

Evan Norton said his job at Abbott Ventures is to go out and find new business that Abbott can enter into.  Abbott Ventures focuses on emerging medical technology companies that have the potential to provide long term strategic growth options for Abbott.  Mostly AVI looks for early stage opportunities and makes it possible for early stage companies to gain critical access to capital, in return for bigger equity stake.  “Our job is to identify the next Spinal Modulation earlier”, said Norton, referring to Mir Imran’s company that was recently acquired by St. Jude.  AVI does not move to non-buying term sheet phase earlier, in the process.   “About a 4th of the capital in our syndicates, comes from China”, said Norton.

Among corporate venture funds, Abbott Ventures tends to be highly creative in putting together early stage deals.  AVI focuses on medical devices, drug/ device combinations, diagnostics and unique drug delivery technologies.  An absolute key aspect of putting together a deal is flexibility on both sides, said Norton.

Mir Imran, Chairman and CEO at InCube Labs, also runs VC fund at InCube Ventures, along with an online crowd funding platform at Venture Health.  Currently, there are about 9 companies that are incubated at InCube Labs.  The Spinal Modulation deal happened with SJM “because SJM was creative in putting together a deal they could live with and we could live with”, said Imran.  Most recent buzz has been around Imran’s company, Rani Therapeutics, which has developed a technology to convert injectable biologics (such as insulin and Humira) into pills, allowing millions to escape the needle prick.

“Rani has a powerful platform and many large pharma companies are talking with us to convert their injectable drugs into pills”, said Imran.  According to recent announcement, Novartis has joined previous investors Google Ventures, InCube Ventures and Venture Health, in a Series C round of more than $25M and similar deals are in the works with other investors.  The deal will allow Rani to evaluate Novartis molecules on the new platform, with equity investment and all expenses for testing of the molecules to be paid by Novartis, said Imran.  Imran avoided entering into license negotiations, at this stage.   “If the technology delivers expected results with Novartis molecules, then we can sit down and put a licensing deal at a later time”, said Imran.   

How has Imran managed to create mutually beneficial conditions for deal negotiations, with large pharma?  “From small company perspective, I don’t like to give away rights too early”, said Imran.  Most of Imran’s companies come out of R&D at InCube Labs.  “We keep our burn rate low and keep a relentless focus on execution”, said Imran.  

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