Posts Tagged lab-on-a-chip
R&D Engineer w/ Analytical Instrumentation, Systems Integration Exp – Sunnyvale, CA
There are several exciting opportunities for product development research associate/ technician/ engineers in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as competitive benefits package. Company is found by a veteran leader and focuses on development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. This role requires working with a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.
Testing, development and optimization of functional biochips, fluidic cartridges & analytical instruments; Support document prep; Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations; Process development & optimization related to biomolecular sensing; Support all aspects of technology transfer to & from development partners; Develop, test & execute QC procedures; Process troubleshooting to determine root cause & find possible engineering solutions.
Requirements: MS in bio-, mechanical-, electrical- or chemical engineering, chem or biochem, or related; 5+ years hands-on R&D, engineering or product development and project/ people management experience. Experience in developing custom equipment by collaborating with external vendors or internal engineering resources; hands-on experience in mechanical design and in building & operating electronic systems; Proficiency in CAD design; Experience w/ statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView); Experience with standard biotech laboratory and/or manufacturing equipment & working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules); Experienced using diverse analytical instruments e.g. oscilloscopes, DAQ interfaces; Experienced in cGMPs & in authoring DOPs, BRs, FRs; Experience in V&V of instruments and processes; and Knowledge of data analysis methods.
Optics & Photonics Research Scientist/ Engineer w/ microfluidics/ lab-on-a-chip Exp – Sunnyvale CA
This is an exciting opening for interdisciplinary research scientist/ engineer with experience in photonics, material science and/or biological applications product development to work in multi-disciplinary team, in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as a competitive benefits package. Company is founded by a veteran leader & focuses on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.
Responsibilities: Support optofluidic platform technology development, & development of single-molecule detection technology with novel reagents & fluidic cartridges, as well as instrumentation for detection, sample preparation & corresponding software; Support diverse aspects related to mid-stage development of a bio-chip based, optofluidic diagnostics platform; Apply diverse knowledge of design principles, practices & implementation in complex systems & assignments; Design, optimize, test, & support validation of optofluidic chips, optical/fluidic interfaces, sample processing technology & instruments, in collaboration with other groups & external suppliers; Develop, evolve & maintain custom optoelectronic systems used for testing and characterizing optofluidic systems; Analyze & present data including images, time traces, assay flows, optical spectrums; Conduct statistical analysis & build/implement/test models for stochastic, high-volume data; Support all aspects of technology transfer to and from internal and external partners; Interface with internal resources and external vendors to design, test & validate equipment.
Requirements: BS/ MS in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related plus 1-5 years hands-on R&D or engineering experience; Extensive theoretical and hands-on experience in optics/photonics; Experience bridging the fields of photonics/optical engineering, microfluidics/lab-on-a-chip & statistics; Exp in design of optical systems (free space & chip based) & in using simulation software eg. ray tracing software for system design & FEM/FDM/BPM etc for chip design: Proficiency in statistical analysis (e.g. Python, JMP, Matlab, etc.) as well as instrument-oriented programming language(s) (e.g. Python; LabView); Experience in using diverse, analytical instruments such as oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc. Expertise in optofluidics, Hands on ability to work-with/manipulate/couple optical fiber and respective components, Proficiency with digital/analogue signals & systems; Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical) and Circuit design and simulation experience are all HUGE PLUSES.
Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!
Software Engineer w/ experience building products in multi-disciplinary envt – Santa Clara, CA
This is an exciting opening software engineer with experience software & hardware development to design, develop & implement a growing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents & custom instrumentation. The company is founded by a veteran leader and is developing single molecule detection technology, and is focusing on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications.
Responsibilities: Lead / Support Software, Firmware & UI development aspects related to the development of novel, diagnostic instrument platforms; Develop control/analysis software for RUO (Research Use Only) & FDA regulated instrumentation; Develop / Contribute to a custom user interface for scientific & medical diagnostic systems; Support all aspects of technology transfer to & from internal & external partners; and work with a multidisciplinary team of experts.
Requirements: B.S. with 3+ years of relevant experience (Level I), B.S./M.S. with 7+ years of relevant experience. (Level III). Requirements also include, Significant experience with instrument-related software engineering using C#; Experience with Python programming; Exp w/ industry coding best practices (Git management, unit testing, documentation, etc; Experience developing, implementing, consuming & supporting contracted APIs. Also preferred: Experience with interface standards (e.g. GraphQL, OpenAPI, etc.); Experience with firmware level interaction (e.g. C). Experience with delivering quality conformant software (e.g. SaMD); Experience with complex data analysis challenges; Ability to develop custom equipment with external vendors and/or internal engineering resources.
Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!
Senior Manufacturing Engineer – S. San Jose, CA
Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.
Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.
Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency.
Associate Director/Director Validation – SJ /QUALITY – QA TEAM
There is an immediate opportunity for Director of Validation in San Jose, CA in a pharmaceutical company with novel drug delivery technology. The company recently had an IPO event and the stock has held very well and the technology holds promise to be a game changing improvement in the quality of care for many patients. The company has a world class team in place. Director of Validation is a hands-on role responsible for the execution of validation activities: To develop & implement harmonized validation processes & practices; Develop a qualified team; Manage validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment.
Skills & Experiences:
Responsibilities: Ensure development & implementation of validation strategies & internal SOPs; Write & review qualification & validation documents; Lead & support qualification & validation of cGMP equipment, facilities, utility systems, cleaning & manufacturing processes; Develop & maintain risk based, quality driven procedures & practices; Lead risk assessment activities; Identify, hire & develop, manage & support company’s validation expertise; Support change control program with respect to facility, utilities, equipment, cleaning & computerized systems validation changes; Evaluate validation impact of manufacturing process changes & equipment upgrades; Complete activities related to regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.; Ensure Quality meets or improves on budget, cost & efficiency targets (KPI’s) in line with business objectives; Support QA activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs; Other duties/activities may be necessary to support departmental or company goals.
Skills & Experience: BS in life science or engineering; 10+ validation exp in bio/pharma industry; 5+ years of supervisory/managerial experience; Knowledge Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) & validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500; Knowledge of international & domestic cGMP regulations for pharmaceutical manufacturing; Technical writing, problem solving & analytical skills; Ability to review, analyze, summarize & interpret data, draw conclusions & make decisions/ recommendations; and Experience in project management.
Quality Assurance – S. SJ
There is an immediate QA position available for support & performance of QA/QS functions/activities and adherence to applicable regulatory standards for medical devices. This is a vascular company founded by a seasoned entrepreneur whose previous company had $1B+ exit. This opportunity will offer competitive salary plus stock with huge potential.
Skills & Experience Required: BS in Science related area; 10+ yrs experience in FDA regulated industry; Exp with Quality Assurance practices & systems; Knowledge of ISO 13485 and FDA 21 CFR 820; MasterControl administration/process ownership; Maintain compliance of a certified QMS related to configuration control, document control, and change control. ASQ Certifications are a plus.
Responsibilities: Support devet & maintenance of QMS, ensuring alignment of corporate operations applicable regulations; Serve as system administrator for MasterControl Electronic Document Management and Training System (EDMS), including responsibility for configuration, user training, account management, training course creation and assignment & assessment of upgrades & patches. Maintain validated state of system throughout system lifecycle. Manage, process & track controlled documents from the Document Change Order (DCO) process until document approval or retirement, including updating related controlled documents; Revise controlled documents as appropriate & ensure timely reviews. Manage electronic approval of records/documents via DocuSign; Monitor & track completion of quality system records including CAPA, Deviation, and NCMR; Monitor training compliance & report any issues to management; Maintain Approved Supplier List (ASL) and ensure supplier files are current; Perform raw data review in support of technical reports and regulatory filings & Issue, track, and perform quarterly audits of laboratory notebooks. Assess corporate operations against quality system regulations, issue identification/ resolution including proper and timely documentation; Prepare quality metrics & reports; Facilitate & conduct internal & external audits; Perform history record review & disposition of device batches. Review/approve facility records as needed (pest control reports, cleaning logs, and environmental monitoring reports & Manage archival of hard-copy records.
Senior Manager CMC, Analytical Development – North San Jose, CA
There is an exciting job opportunity in San Jose, CA, to work on novel projects involving drug-device combinations for treating chronic diseases & participate in method and tech transfer from R&D to Manufacturing as appropriate. This is an exciting opportunity in a rapidly growing company to work with a world class team, on game changing technology with HUGE potential.
Requirements include: BS/MS in sciences PLUS 5+ years relevant bio/pharma experience; biologics analytical development exp in biophysical techniques & analytical characterization of peptides & proteins; solid oral dosage and/or parenteral sustained release formulation exp, exp in process development from early to late phase development; experience of working in GLP/GMP regulated environment, drug-device combination exp; knowledge analytical techniques such as various HPLC modes & detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc, for product characterization, comparability testing and PK/PD analyses; Exp in method validation and specification setting; Assessing chemical & physical stability of formulations, identifying stability, manufacturability, & performance critical quality attributes. Experience in protein purification & biologic formulation is a plus.
Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and most require deep industry experience. Contract opportunities are posted at the bottom. If you have an interest then please send an email (resume as an attachment) at wd_darshana at hot mail dot com. Please bookmark and keep checking here for updates on new opportunities.
Director of Assay Development – Palo Alto, CA
There is an exciting opportunity for Director of Assay Development in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions. Candidate will work closely with electrical engineers to transform an oligonucleotide-based assay from optical measurements to electrical measurements on company’s proprietary platform & will play a key role in development of a high throughput assay for clinical R&D studies.
Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis & management skills; knowledge of oligonucleotide-based assay & application on biosensor based Field-Effect Transistor (Bio-FET) for developing in-vitro diagnostic device; Expertise in assay devt & validation methods, in design & prosecution of in vitro bio-recognition -based assays, and 3-5 years of hands-on exp in biomarker quantification using a variety of biophysical techniques. Aptamer-related experience is advantageous.
Responsibilities: Manage team of lab researchers; Assist with data prep for analysis & reporting; Maintain lab equipment functionality; Track inventory, lab records, good lab practice (GLP) and safety; & Troubleshoot; Adapt assays to multiple platforms & optimize biosensing measurements; Validate biochemical assays & biomarker quantification; Develop & set-up biochemical & in vitro assay for high throughput platforms; Train team members; Provide technical information, experimental assay design & data analysis to team members.
Senior Scientist of Assay Application – Palo Alto, CA
There is an exciting opportunity for Senior Scientist of Assay Application, in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions.
Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis skills; experience in protein and nucleic acid work using binding assays molecular interaction analysis (e.g. ELISA, SPR, FRET), protein microarray and surface chemistry. Aptamer-related experience is advantageous.
Responsibilities: Assist w/ data preparation for analysis & reporting; Manage lab – inventory, records, equipment functions & safety; Troubleshoot bench work; Assay Development, design & analysis; Work multidisciplinary team to design, develop & optimize assays & devices (optical and electrical); Adapt assays to multiple platforms & optimize biosensing measurements.; Validate biochemical assays for biomarker quantification; Facilitate technical communications between engineer and assay development teams.
Mechanical Engineer – Santa Cruz, CA
Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for Mechanical engineer.
Head of Manufacturing Engineering – San Jose, CA
There is an exciting opportunity for Head of Manufacturing Engineering in San Jose, CA. This is an exciting opportunity with high potential.
Responsibilities include, implementing pilot manufacturing line, develop components & assembly manufacturing processes including materials science and selection, develop processes for injection molding, conventional & novel polymers, micro-product molding, converting & sealing plastic films, micro-tablet compression, clean room processing & large molecule processing.
Required: BS in Engineering plus 12+ years of mechanical engineering experience in medical device industry. Any of the following, highly desired: Experience in consumer product medical device, pharmaceutical (transdermal and solid dosage), and combination product design, manufacturing process development, manufacturing equipment design and development, pharmaceutical and sterile device packaging development, 3-D metal and plastic product design, tooling design and fabrication, injection mold design and fabrication, CNC and g-code programming, production engineering management, maintenance management, manufacturing management, and project management and experience in new product launches through heritage product manufacturing.
Software Engineer – Santa Cruz, CA
Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for SW engineer. Embedded microprocessor experience and windows app experience is required. Highly preferred, design/coding experience for embedded systems with wearable/motor-driven devices.
CFO – San Jose, CA
There is an exciting opportunity for CFO for a company, in San Jose – CA. Found by a veteran leader the company focuses on disruptive drug delivery platform technology. 15+ years M&A and licensing deals experience in bio/pharma industry is required.
Director of Program/ Project Management – Santa Cruz, CA
There is an exciting opportunity for Director of Program/ Project Management for a company located in Santa Cruz – CA. This company is found by a veteran leader and focuses on an array of brain computer interface devices to address a range of neurological problems. Candidate is required to have 4+ years of medical device program or project management experience in electromechanical systems area.
Head of Regulatory – San Jose, CA
There is an exciting opportunity for Head of Regulatory for a company, in San Jose – CA. Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.
Design QA Scientist – Pleasanton, CA.
Responsibilities: Support DQA Principal Scientists and Project teams; Review & approve documentation consistent with design control regulations; technical verification, risk; Assist DQA project team to assess completion of milestone deliverables; Assist in the review and development of high SOPs; Support audits/inspections; Other duties as requested.
Requirements: Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline, or equivalent combination of education and work-related experience.
Preferred: Job-related Professional License(s) or Certification(s) and 5 Years Development, Manufacturing and/or Quality Assurance experience under established quality regulations.
Clinical Research Associate II – California
Responsibilities include, participate in design, planning, implementation and overall direction of clinical research projects; ensure compliance with the overall scientific study objectives; work with international investigators and key customers as well; Travel to field sites to monitor studies; Receive general instructions; plans and prepare studies; Review study protocols, report manuscripts; Contribute technical & clinical operations expertise for these documents; Work with Data Management & Biostatistics staff on the design of documents and processes for the collection of study data from participating sites; Collect & maintain legal and regulatory documentation, as applicable; Assume responsibility for training & coordinating certification of study site personnel; Ensure accurate and complete study management/data collection and transfer to data management; Ensure site compliance with regulations and study protocol; Monitor the sites and provide technical assistance, as necessary; Assist, prepare and manages study timelines; Manage material logistics for the studies; Conduct reference material testing in-house. Organize investigator meetings, as necessary; Participate in Project Team Meetings; Keep informed of trends and developments in clinical research; Know & effectively use the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity; Analyze alternative approaches to solve problems or devleop new perspectives & existing solutions. Bachelors degree in a scientific discipline or related field, or equivalent combination of education and work experience is required. Certificate of completion of sections 1 through 6 is required. Minimum 2-6 years of relevant clinical research experience and knowledge of regulations and guidelines is required.
Clerk – San Jose/ Santa Clara, CA
There is an opportunity for a Clerk in a biomed company, located in San Jose/ Santa Clara, CA area.
Responsibilities: Follow standard operating procedures to enter orders for high complexity clinical lab tests; Be responsible for efficient and accurate entry of customer and patient demographic data, clinical information, test request information and physician information; Review, understanding, and executing customer-specific requirements for order entry; Create service requests in CRM system to document issues and work closely with client service team to resolve and escalate incomplete or unclear order issues; Check work of others to ensure order entry quality; Troubleshoot problems & assist employees with process questions; Fax requests to customers to resolve unclear orders; Run queue reports to ensure daily tasks are completed; Assist account set up administration; Act as training resource for department employees; execute process improvement recommendations; Retrieve forms from lab; Escalate issues to appropriate internal resources; Interact with Finance team to provide patient billing information in a secure manner.
Skills: 2+ years experience working in the clinical laboratory, medical, order management, or related field; Experience using Customer Relationship Management (CRM) Software (e.g. NetSuite, Salesforce.com), laboratory information systems. Microsoft Office Suite a plus. Must be able to follow laboratory procedures and must adhere to the laboratory quality control policies; Ability to identify & act on issues within an order that may impact customer satisfaction & test turnaround time; Must be able to type 45 words per minute with excellent accuracy; Must be able to lift up to 35 lbs.
RMD Biospecimen Scientist – Pleasanton, CA — 6 mo. contract
The BioSpecimen Management (BSM) Scientist position will facilitate the daily operations associated with providing the best-in-class simple biological solutions to customers. Biospecimen solutions include acquisition, characterization, and management of biological materials, and build of select panels fit for purpose for RMD research. Responsibilities include deliver simple, efficient solutions, facilitate receipt of shipments of human biological samples, verify sample integrity and data accuracy, process (centrifuge, aliquot, and pool) samples, consolidate inventory, retrieve and distribute samples, maintain inventory of supplies and ships supplies and facilitate routine activities in the build of custom panels, in close communication with team members. Also includes, responsibility for the accuracy, quality, and timeliness of all assigned projects, tasks and related activities, accontablity for electronic records management, use of validated systems, and keep supervisor informed of project status. Requires, Associate degree or certification in Biological Science or related field, or equivalent combination of education & experience, experience handling biological samples, understanding of good laboratory, data and documentation practices, and experience with basic computer application.
Scientist 1 – Pleasanton, CA: 6+ Months Contract
This opportunity is with NGS workflow controls for the RSS assay development team that identifies and tests cutting edge reagents, technologies or protocols that are supporting the development of products in Oncology, Genetics, Infectious Disease and Automation/Sample Preparation. Areas of interest include short and long read sequencing technologies, low input and difficult sample preparation methods and creating integrated workflows. Candidates must be able to work in a collaborative, exciting, and fast-paced team environment.
Responsibilities: Operate & maintain equipment, interact with LIMS databases, complete projects in a timely fashion, research & development, and give presentations at weekly meetings. Additional responsibilities: Operation of different genomics analysis technologies such as next-gen sequencing, microarrays, real time PCR and ancillary equipment for quality control and validation; Develop, validate & apply methods for various genomics methods mainly focused on sequencing; Process include nucleic acid isolation and quantification, PCR amplification, library preparation, plate normalizations and Work with senior personnel, perform early development activity to create new workflows that are robust, cost-effective and time efficient; Collaborate with R&D to transfer new assays and methods to automation platforms; Work closely with IT group and instrument vendors to develop and implement automated workflows; Accurately and consistently record experimental methods, materials & results in electronic laboratory notebooks; Analyze data, evaluates results, form conclusions, and determine future experiments; Present findings or comprehensive project status reviews at internal/external seminars/meetings; Apply advanced technical writing & graphical skills to produce reports & documents; Prepare summaries, reports, presentations, manuscripts, etc.; Present early development work including scientific background information & project updates at internal staff meetings and at cross-functional team meetings; Determine all chemicals, reagents & supplies needed for a project; develop a strong knowledge of all related third-party vendors and their technologies and products; Establish and maintain productive relationship with personnel in development; orient & trains new Research Technicians & peers.
Requirements: Strong Molecular Biology background or Biochemistry or Immunology background with strong knowledge of Molecular Biology; Experience performing next-generation sequencing methods (Exome, whole genome, RNA sequencing) a plus; Bachelor of Science with a minimum of 2 years of lab experience.