Jobs – April, 2012

For the opportunities below, please send resume to wd_darshana at hotmail dot com.

Quality Engineer – San Jose, CA

Drug delivery company has an immediate opening for Senior Quality Engineer with 10+ years pharmaceutical industry experience in sterile manufacturing and process qualifications for injectible drugs. Experience in documentation and batch process and automation quality systems setup and management experience is required. Qualifications should include BS in Chemical Engineer, Mechanical Engineering or related. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.

Clinical Project Manager 

The position will support US and OUS clinical trials in a cross-functional role to support the clinical study team.

Essential functions include manage clinical trial operations with a specific focus on European feasibility investigations, establish and maintain study master files, work with sites to prepare submissions, secure study documentation, and negotiate contracts, manage case report form data and monitoring activities, develop and refine clinical trial procedures, create and prepare materials for Investigator, Coordinator, and DSMB meetings, prepare Case Report Forms, support field clinical staff with significant involvement in site assessments, monitoring activities, site audits, and site closures as needed, write and file Adverse Event reports, annual reports, and other communications with Ethics Committees, Competent Authorities, and Institutional Review Boards, perform clinical data entry, report generation, work with sites to resolve data queries, support investigators with publication activities, as needed, provide regulatory support for US and OUS clinical submissions, interface with Regulatory Affairs department to provide support for ongoing regulatory activities, provide support for new and ongoing regulatory submissions, provide support for Product Development and Operations, development, writing of Manuals and training materials, and participate in clinical validation and product development verification activities

BS in life sciences or equivalent with a minimum of 5 years related experience in supporting medical device clinical trials is required.  Experience working directly with US and EU sites and working with clinical data and database experience, strongly desired.  Familiarity with literature searches, experience monitoring sites, and scientific writing skills, preferred. About 10% travel will be required.

Manufacturing/ R&D Engineer – San Jose, CA

There is immediate opening for R&D Engineer with 10+ years of deep experience in injection molding. Experience in Autocad and SolidWorks and BS in Mechanical Engineering is required. Experience in vacuum forming, a huge plus. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.

Machinist – San Antonio, TX

Innovative medical device/ biotech in Texas has an immediate opening for Machinist. The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup. (Stock options could make this a once in a lifetime kind of an opportunity). The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems. The candidate must be familiar with fabricating small parts or tooling on a lathe and mill. Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.

Pharmacologist with In-Vivo Experience: San Antonio, TX

A dynamic company, found by a veteran leader of several successful startups, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential.  The applicant must have a BS with a minimum of 8 years (or MS with at least 6 years) of hands-on laboratory experience. The individual is expected to have a breadth of experience in in-vitro and in-vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.

The applicant will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the applicant will set up and run a variety of routine in vitro research paradigms as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The applicant will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects. The position requires a strong background in cell biology, chemistry, biochemistry, immunology, physiology or a related area. Position, salary and benefits are commensurate with experience.

Sales Opportunity – Palo Alto, CA

There is an immediate opening for a business development/ sales individual with 10+ years experience in selling regulatory compliance, project management and IT in the regulatory arena in LifeSciences (Biotech, Pharma, Medical Devices, CRO) and Genomic Companies. Experience should be in compliance consulting, not clinical consulting. Responsibilities include both sourcing new leads and closing deals. Compensation will be commission based for first 3 months and will include salary plus commission after that. This is an opportunity to work with a veteran CEO and will include stock options.

Ultra Low Power Analog Design Engineer – San Jose, CA

There is an opening in CA & TX for ultra low power analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise. Compensation will be commensurate with experience, in addition to the stock options. The stock options could make this highly attractive opportunity. The position requires 6+ years of experience with medical device low power analog circuit design and embedded design experience.

My colleague is working on the opportunities below. If you have an interest, please mention the opportunity in the subject line, with your name and send your resume and I will forward it to him.

Director of Clinical – San Jose, CA

VP of RA/QA – Redwood City, CA

Senior Manager of RA/QA – San Francisco, Ca