JOBS – June, 2015


I have new opportunities in California and Texas 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 medical devices.  I will post details as and when I get full descriptions.  But I am looking forward to receiving resumes for the opportunities listed below and I am submitting them, as I receive them.  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.

Senior Mechanical Engineer – San Jose, CA
12+ years of Class III medical device is required, with experience in machining, injection molding etc.

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

Drug Safety Assistant – Contract 6 – 12 Months — Berkeley, CA

This contract position is responsible for processing serious adverse events (SAEs) in compliance with standard operating procedures (SOPs) and national and international regulatory safety and pharmacovigilance regulations, such as the Food and Drug Administration (FDA), International Conference of Harmonisation (ICH), World Health Organization, and country and regional regulations for the reporting of adverse events to regulatory agencies.  The contractor in this position will be responsible for implementing pharmacovigilance guidelines and ensuring the uniform and timely processing of adverse event data on investigational and post-marketing products, as assigned.

Responsibilities:

The level of incumbent will determine the level of independence for the following duties:  See complete details in JOBS category at http://www.darshanavnadkarni.wordpress.com

* Process SAEs in compliance with SOPs and national and international regulations, and assist or lead in preparing SAE reports for management and regulatory agencies, assist in the preparation of new drug application (NDA) updates, investigational new drug safety reports, investigator communications, product labeling/packaging inserts, and other reports as necessary,  Assist or prepare aggregate data for safety review sessions.
* Support audits and inspections; create and maintain audit-ready files including training files.
* Process and review safety narratives for adverse event cases as required.
* Perform reconciliation activities including performing review of source data of SAE files.
* Ensure all SAEs are handled in accordance with safety regulations and department procedures and communicate to internal/external groups as necessary during scheduled holidays as well as non-business hours.
* Provide back-up support to the Drug Safety Coordinator with the following duties:
* Maintain electronic/paper files including management of the central Drug Safety & Pharmacovigilance file room.
* May be responsible for daily on-site filing and retrieval of adverse event case files and maintenance of the Client adverse event file storage facilities within the Case Management Center.
* Responsible for scanning and uploading adverse event case information to our safety systems, monitoring electronic mailboxes for adverse event reports, responding to queries and follow-up local reference numbers when required.
* Perform other operational tasks in support of Drug Safety & Pharmacovigilance Operations as required by Management
* Responsible for monitoring the inbound mailboxes, fax machines and/or other inbound systems for adverse event cases, and forwarding to the appropriate DSP Manager for triage
* Maintain electronic/paper files including management of the central Drug Safety & Pharmacovigilance file room.
* May be responsible for daily on-site filing and retrieval of adverse event case files and maintenance of the Client adverse event file storage facilities within the Case Management Center.
* Responsible for scanning and uploading adverse event case information to our safety systems, monitoring electronic mailboxes for adverse event reports, responding to queries and follow-up local reference numbers when required.
* Perform other operational tasks in support of Drug Safety & Pharmacovigilance Operations as required by Management
* Responsible for monitoring the inbound mailboxes, fax machines and/or other inbound systems for adverse event cases, and forwarding to the appropriate DSP Manager for triage
* 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

Qualifications:
* For the Senior Associate, 8 plus years of related experience OR training in health-related fields such as nursing, pharmacy or medicine and 4 years of related experience. Strong communication skills including appropriate email etiquette is required
* Impeccable ethical standards and integrity.
* Knowledge of both domestic (FDA) and international (ICH) regulatory pharmacovigilance requirements.
* Able to maintain confidentiality (especially on patient records), quality and accuracy.
* Familiarity with medical terminology.
* Demonstrated attention to detail, follow-through and initiative.
* Strong team orientation and be collaborative, but must be able to work independently while processing adverse event cases.
* Required: demonstrated mastery of Microsoft Word, and a working knowledge of Microsoft Excel; familiarity with Argus, the MedDRA coding dictionary and the WHO Drug coding dictionary.  Note that this contract position does not require direct interaction with Argus but familiarity and understanding are essential.
* Must be effective working in a fast-paced environment and possess good judgment; must be flexible and quickly adapt to changing priorities.
* The person in this position must be able to remain in a stationary position 50% while operating a computer and/or other office equipment, occasionally move about the office to retrieve files and attend meetings.

Drug Product CMC Contractor – Pleasanton, CA

There is an immediate opportunity for Senior Drug Product CMC contractor at a revolutionary company bringing together high tech and biotech to discover and develop more effective medicines for treatment of cancer. We are changing the current paradigm of drug discovery and development.  This position will be responsible for managing drug product manufacturing activities for one or more of company’s clinical compounds. Travel will be required on an as-needed basis to liaise with CMO staff and oversee manufacturing activities. This can be either a part-time or full-time role, 2-5 days per week, for an initial term of 12 months.

Responsibilities:
* Implement CMC strategies for one or more compounds in clinical development (parenteral and oral solids)
* Manage, interact, and build relationships with CMOs for drug product process development & scale-up studies & manufacturing clinical trial material
* Design process development studies as appropriate to improve process robustness & understanding
* Write &  review development history reports
* Maintain all relevant files & reports for regulatory submissions
* Author and review CMC sections of INDs, CTAs, Annual Reports, NDAs etc. for global regulatory submissions
* Liaise closely with the CMC team including Process Chemistry and Formulation, Analytical and Stability groups as well as Quality Assurance for review of batch documentation and release of product
* Interact with Regulatory and Clinical team project representatives for CMC project deliverables
* Lead investigation activities for non-conforming materials and implement preventive actions
* Travel: Up to 15%

Qualifications:
* MS or PhD in Chemistry or a related pharmaceutical science is required
* Pharma/biotech industry experience in pharmaceutical development and manufacturing preferably with small molecules (minimum 10 years with a MS; minimum 5 years with a PhD)
* Thorough knowledge of drug product formulation and manufacturing is required
* Proficiency in either parenteral or oral solids manufacturing
* Proven track record of working with CMO partners to meet drug product manufacturing project milestones
* Process validation experience and knowledge of analytical methods and data is desirable
* Strong knowledge of global current Good Manufacturing Practices (cGMP).
* Experience preparing Chemistry, Manufacturing and Control (CMC) documentation for regulatory filings, particularly in Common Technical Document (CTD) format, is highly desirable
* Strong problem-solving and troubleshooting abilities
* Ability to work independently and in a team environment
* Excellent oral, written, and interpersonal communication skills

Senior Quality Engineer – San Jose, CA Requires 8-10 years medical device quality engineering experience and educational background in mechanical or electrical related engineering. Include brief summary of your background in the email and mention if you have class 3 device experience or if you have any sterile pharma experience.

Senior Manufacturing Engineer – San Jose, CA Required 8-10 years medical device manufacturing engineering experience and Bachelors or equivalent in mechanical or electrical related engineering area.  Include brief summary of your background in the email and mention if you have class 3 device experience or if you have any sterile pharma experience.

Document control – San Jose, CA Biologist/ Physiologist with large animal in-vivo experience – San Jose, CA

Polymer Chemist/Drug Formulation – San Jose, CA         

Mechanical Engineering Technician – San Jose, CA

Senior Mechanical Design Engineer – San Jose, CA

Electrical Engineering Technician – San Jose, CA

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