Jobs – July, 2015

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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.

Key Responsibilities
* 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.

Key Qualifications
* 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.

BioChemist – San Jose, CA
Scientist I-III, Potency Assay Development – 6-12 month contract
Scientist I/III Protein Analytics (Contract 6-12 months)
Senior Manager / Associate Director, Regulatory Affairs (Clinical)
Director, GxP & Research Applications
Director, SG&A Applications (Finance, Supply Chain, HRIS, and Reporting Systems)
Director/Sr. Director Corporate Communication
Medical Writing QC Reviewer – 12 month contract (x2)
Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract)
Copy Editor – 6-12 month Contract
Director/Sr. Director, Marketing
Laboratory Assistant
Vice President and General Counsel
Sr. Director, Quality Assurance – Commercial
Director/Sr. Director,Quality Assurance, Development
Specialist/Sr. Specialist/Manager – Quality GCP Compliance
Post-Doctoral Fellow (Senior), Analytical Development – Protein Analytics and Characterization

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