Posts Tagged Molecular Biology
Reagent & Assay Development Research Associate – Santa Clara, CA
There is an exciting job opportunity for Reagent & Assay Development Research Associate in Sunnyvale, CA with a company developing innovative single-molecule detection & ultra-high sensitivity platforms based on its expertise in optofluidics, assay development, system integration and microsystem technologies. This product development infrastructure and suite of proprietary technologies are ideally suited for the robust development of advanced diagnostic products. Competitive compensation will include an opportunity to participate in equity.
Candidate Requirements: Hands-on experience in protein & nucleic acid biochemistry, bioassay development and spectroscopy/microscopy; BS/ MS in biochemistry, biophysics or bio-analytical chemistry with 0-2 years of industrial experiences (recent graduates welcome to apply). Strong understanding of biochemical & bio-analytical techniques for protein, nucleic acids and nanoparticles/biopolymer characterization is required. Also preferred, hands-on experience in Fluorescence Spectroscopy/Microscopy, Protein Assays, Electrophoresis, Dynamic Light Scattering/Zeta Potential, UV-VIS Spectroscopy, Chromatography, qPCR); Some experience with immunoassays and nucleic acid assays. Excellent foundation of data analysis procedures and knowledge of basic statistical concepts is ideal. Experience with reagent preparation for single-molecule detection techniques is a big plus.
Bioanalytical Scientist – N. San Jose, CA
There is an exciting immediate job opportunity for a bioanalytical scientist in San Jose, CA to work on novel drug device combinations for treating chronic diseases. There are three opportunities and position, salary and benefits will be commensurate with experience. This position will be involved in the development of in vitro/in vivo models by performing a variety of microplate assays; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality; Perform routine data management tasks; Support regulatory efforts; Perform other duties as assigned.
Requirements: BS with 2-5 years or MS with 0-3 years or Ph. D. with 2+ years of industry experience is required; Also required, Experience in preclinical & clinical research; experience in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS; Experience with microplate assays; Hands-on experience in automation and liquid handling in a bioanalytical lab setting; Experience working with statistical software like Excel, GraphPad Prism and Softmax Pro; and Experience with writing reports/protocols and SOPs. Experience with Luminex MapX technology is an advantage.
R&D Scientist – N. San Jose
A drug delivery company with unique technology to deliver biologics has an exciting job opportunity in San Jose, CA for R&D Scientist.
Requirements: BS/MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related; 5+ years pharma or biotech experience in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must. Candidates must have experience of working in GLP/GMP regulated environment and working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities. Also required, knowledge of state of the art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell based assays etc for product characterization, comparability testing and PK/PD analyses. Experience in working with drug-device combination products is a plus.
Responsibilities: Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes; Establishing and managing reference standard and stability programs; Participate in method and tech transfer from R&D to Manufacturing as appropriate; Writing, reviewing and approving CMC sections of regulatory filings; Assessing utilization of resources and identifying when, and where additional resources may be needed; Communicate effectively to the project team and present data at team meetings; Maintain high quality documentation of all activities in notebooks, Other duties as explained.
Molecular Biologist – South San Francisco, CA
An early stage biotechnology company located in S. San Francisco, CA has developed patented technology for engineering mammalian cells to vastly increase their productivity for therapeutic protein or virus production and has an exciting opportunity for senior molecular biologist.
Requirements: Must have PhD in a related field or equivalent amount of experience with recombinant mammalian cell line creation; mammalian cell culture expertise; experience with general molecular biology techniques for designing and constructing vectors and transfecting mammalian cells; experience with protein assay techniques for screening transfected cells. Also highly preferred, Experience with flow cytometry, virology, cell banking, transposase transfection methods; experience with protein analytical methods; knowledge of the regulatory environment related to creating and testing cells destined for GMP manufacturing; and photomicroscopy.
Responsibilities: This position is responsible for helping develop the technology toward full commercialization. Responsibilities include work with cell engineering, vector design and construction, transfection, mammalian cell culture, cloning and screening, flow cytometry, and other related molecular and cellular biology techniques.
Quality Assurance Engineer – North San Jose, CA
There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team to support compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
Responsibilities: Maintain and improve quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements; Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs; Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause; Lead the resolution of quality issues related to non-conformance reports and CAPAs; Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ); Provide QE support to production, purchasing and engineering; Support/lead test method validation activities; Conduct and support the development and validation of appropriate test methods for product and process performance; Develop and initiate sampling procedures and statistical process control methods; Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan; Address systemic quality issues with suppliers or internal groups; Oversee calibration and preventive maintenance program; Assist in the review of lot history records and disposition of product (subassembly and finished goods); Work with engineering to develop adequate inspection criteria; Perform statistical analysis such as capability, gage R&R, and statistical process control; Evaluate product changes for qualification and validation requirements and assist in change implementations.
Requirements: A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, Experience in performing test method validation and Gage R&Rs, Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and BS in Engineering is required. CQE, CQA preferred
Senior R&D Mechanical Engineer – N. San Jose, CA
This is a very exciting opportunity to work at grounds level on a stealth mode project, with a veteran entrepreneur, with several successful prior ventures. Requires 8+ years of medical device product development experience and strong expertise in Solidworks.
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.
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.