Posts Tagged asthma
I have new opportunities in California and Texas; many of them are in in engineering in Quality, Manufacturing, and Mechanical and other job openings in Biochemistry, Physiologist with animal surgery experience and in manufacturing and document control of drug delivery type of medical devices. I will post details as and when I get full descriptions. All opportunities are for candidates located in the United States. When sending your resume, please include details on your current compensation and compensation expectations. Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com. See below a list of additional opportunities.
Post-docs – Engineering – ME, EE, Biochemistry, Pharmaceutical Sciences – CA & TX
Requires excellent and proven problem solving skills.
Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract) – Berkeley, CA
Overview: Responsible for managing the full scope of proper study conduct including, but not limited to, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of Phase 1 to 4 clinical trials. Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.
The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. May determine methods and procedures on new assignments. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
* Lead clinical trial project execution for asthma programs to ensure that trial timelines, costs, and quality metrics are met.
* Serves as primary contact for functional area representatives in managing protocol execution.
* Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
* Forecast and oversee clinical supplies, e.g. study drug.
* Manage study milestones to ensure accurate tracking and reporting of study metrics.
* Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
* Create and manage clinical trial budgets in collaboration with manager and the Vice President of Clinical Operations.
* May provide study-specific direction and mentoring to CRAs and CTAs.
* Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
* Manage adherence to ICH/GCP/local regulations.
* Participate in clinical operations initiatives and programs.
* Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
* Other duties as assigned.
* Bachelor’s Degree with at least 5 to 8 years of CRA experience for the manager level with at least 1 year of staff management experience. The senior manager level requires 10+ years of combined CRA and CTM experience and 3 years direct staff management experience is required.
* Experience in inflammatory diseases, specifically Asthma and/or Chronic Obstructive Pulmonary disease (COPD) is required.
* Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
* Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
* Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
* Excellent organizational and negotiation skills. Proven ability in creative problem-solving and possess sound judgment.
* Team oriented and collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners.
* Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook.
* Working knowledge of MS Project for development and update of clinical study timelines.
* The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment and needs to occasionally move about the office for meetings, to access files, and other office equipment.
* Willing to travel – anticipate up to 25%.
Senior Mechanical Engineer – San Jose, CA
12+ years of Class III medical device is required, with experience in machining, injection molding etc.
Biochemist – San Jose, CA
Senior Electrical Engineer – Austin/ San Antonio – TX
A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience. Experience with closed loop, analog design hardware, microcontrollers, actuators and ultra low power consumption circuit design highly desired.
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.
Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development
Senior Mechanical Engineer – San Jose, CA
This is an exciting opportunity to work at grounds level with a veteran leader, in innovative drug delivery space. Minimum 10 years of medical device experience is required.
Opportunities in Berkeley, CA
If you are interested in any of the opportunities below in Berkeley, CA then send me an email with resume and I will be happy to share more details.
On “Building a Pearl” – Story of Pearl Therapeutics from Concept to Acquisition by Astra Zeneca for $1.15B
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on March 17, 2014
Pearl Therapeutics is a huge success story in the biotech world. At www.bio2devicegroup.org event, Dr. Sarvajna Dwivedi, co-founder of Pearl Therapeutics talked about his own professional journey and about Pearl team, technology and products, that brought the company to pearly stunning $1.15 Billion exit. Pearl Therapeutics was acquired by Astra Zeneca in June, 2013.
Dwivedi began the talk by paying tribute to his mentors, his father, Professor Rewa Prasad Dwivedi, his first role model and a reknowed Sanskrit scholar and poet, his professor Dr. Alan Mitchell at University of British Columbia who imparted important lessons on staying true to fundamentals and understanding the properties of nature, and Silicon Valley’s prolific inventor Mr. Mir Imran, who told him long before he needed to raise money, “don’t ever take investor’s money, unless you can treat it as your own”. Dwivedi said he carried all those valuable lessons in his professional journey.
After his education where he worked on tablets, Dwivedi was invited to join Glaxo to work on inhalation products. When he was concerned about making a jump from tablets to inhalation products, he was told “you know how to keep particles together, you would know how to keep them apart too”. From Glaxo, he went on to Dura, where he worked on an electromechanical inhaler system, a complex 50 part device. Then at Alkermes, Dwivedi put together a team which designed a device with a precessing capsule inside. Each of these opportunities contributed to giving him a stronger grounding into fundamentals.
Eventually, his career journey brought him to Nektar Therapeutics. Nektar was focusing on systemic conditions like diabetes, to be treated by inhalation delivery of drugs like insulin, and on anti-infective therapies for lungs. Dwivedi and his colleagues were looking at delivering drugs uniformly into the lungs for diseases such as asthma and COPD, and especially make drug combinations with standard metered dose inhalers. Global COPD or chronic obstructive pulmonary disease and asthma market is projected to reach $47 billion, by 2017. These were compelling clinical problems that Dwivedi and his colleagues were trying to solve, but Nektar chose to stay focused on other opportunities. Eventually, Dwivedi and his co-founder Adrian Smith formed Pearl Therapeutics and spun it out as a separate company.
Pearl Therapeutics has combined two bronchodilator drugs in one inhaler, and put it into Phase III. Pearl has now demonstrated that it can also combine three drugs, to treat the fatal lung condition, COPD. These drugs typically do not mix well together in a common inhaler and that leads to less than ideal distribution of the drugs in the lungs. Pearl’s secret is its proprietary technology. Dwivedi said the lessons he learned earlier in life regarding staying true to fundamentals and to not fight nature, were most useful in navigating these challenges. The nature of particles is to coalesce, and therefore it’s very difficult to keep them separate for aerosolization purposes. This can be achieved easily with liquid propellant suspensions, such as those in commonly used metered dose inhalers. Pearl creates these suspensions with a proprietary technology utilizing specially engineered phospholipid porous particles. When these inhalers are actuated then the porous particles go back from liquid to vapor, facilitating consistent and uniform inhalation delivery. The porous particles traverse the back of the throat easily and spread aerosols throughout the lung. Astra Zeneca saw the tremendous promise in this technology, the product progression achieved by Pearl, the value of the product pipeline at Pearl, and the Pearl team assembled by Dwivedi and his co-founder, Smith. AZ forked over $1 B+ and acquired Pearl, with a promise to enable Pearl to continue to operate independently. This was very interesting talk and generated a great deal of discussion.