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VP R&D Diagnostic Assays
Job Description SummaryBD is searching for a highly experienced strategic technology leader based in their Sparks, MD facility that can significantly increase BD’s molecular, microbiology, and immunoassay presence (technically/strategically) in the Worldwide IVD Diagnostics market, with a primary focus on Infectious Disease assay development. This position is responsible for leading and guiding the overall research and development team of ~150 associates in molecular, microbiology, immunoassay and cytology diagnostic assays to be practiced on BD’s suite of fully automated diagnostic platforms, including the BD MAX, BD Phoenix IDAST, BD Kiestra Microbiology Lab Automation, BD BACTEC automated blood culture system, BD Veritor POC ImmunoAssay system, BD Focal Point Cytology system, and all new platforms under development by BD Diagnostic Systems. The ideal candidate will possess deep training and experience in the Clinical IVD diagnostics technology space with a track record of recent development and launch of multiple novel molecular IVD assays into the worldwide market, but will also possess a strong foundation in basic clinical microbiology (and virology) and related assay development. The candidate will have strong working understanding of diagnostic methods across the spectrum of DNA/RNA amplification and hybridization technologies, growth microbiology and resistance detection (molecular and growth based), and direct antigen and serology based immunoassay development (lateral flow technologies), and will readily be able to span across all multiple technology spaces to lead/foster the conceptualization, creation, and development of novel inventive new assays for the clinical IVD market. The candidate will understand Diagnostic instrumentation technologies (i.e. PCR, thermal cycling, hybridization, multiplexing, imaging technologies, antimicrobial detection and resistance determination technologies, rapid pathogen detection technologies, etc.). The preferred candidate will be well versed in developing and qualifying new assay products for clinical trials and regulatory clearance. The candidate will have a broad and current view of the IVD Molecular, Microbiology, and Immunoassay Infectious Disease assay market. # Job Description Key Areas of Focus & Responsibilities + Working with BD Diagnostic System’s Molecular, Microbiology, and Immunoassay Business and Platform Leaders, R&D Instrumentation Engineering and Lab Automation leaders, Strategy and Business Development and the Clinical/Medical and Regulatory Affairs functional leaders, help derive and execute effective (winning) assay content strategy for BD’s IVD diagnostic platforms that includes innovative molecular, microbiology, and immunoassay technologies, clinically relevant assay or systems solutions, and leading edge clinically relevant assays across the spectrum of BDDS’s Diagnostics IVD system portfolio. The primary focus of the role is infectious disease assays with primary focus on molecular assay content, but with the charge to investigate other assay content spaces or partner with collaborators for assay development and generation of novel diagnostic assay content.
Provide leadership, optimal staffing, and overall management of molecular/microbiology/immunoassay/cytology R&D teams located at our Sparks, MD, Quebec City, CAN, San Diego, CA and Durham, NC sites. Recruit/Select best in class talent and leaders (functional and program) for key assay development capability. A capable assessor of talent, able to recruit and build excellence in technology and product development across the defined assay spectrum.
Make and execute capability/capacity and organizational alignment plans and actions to optimally organize the Molecular, Microbiology, Cytology, and Immunoassay R&D sub-functions, ongoing, as project and technology needs emerge and change over time.
Provide overall guidance to BDDS’s assay development agenda, from an R&D best practice and GPDS (Global Product Development System - BD’s formal development process) to accelerate the development of multiple IVD assays in parallel, all running concurrently andoptimally/efficiently,to deliver key syndromic (clinically associated) assays to the market in a synchronized fashion.
Assess/acquire technologies and novel assay content via partners, collaborators, IP licenses, etc. as core/integral components to enhance delivery of critical assays and capabilities across the molecular (DNA/RNA) assay menu and automated molecular/microbiology/cytology/immunoassay platforms.
Via collaborations, develop/acquire novel technologies aimed at the leading edge molecular, microbiology, immunoassay IVD diagnostic solutions set through internal/external Research or Technology Development programs.
Search/synthesize/select the acquisition or access to novel molecular, microbiology, immunochemistry technologies or methods to assure rapid/sensitive detection of bacteria, viruses, or proteins (immuno).
Coordinate with VP of Engineering and Product Development, Diagnostic Systems and to enable world-class IVD instrumentation and fully automated molecular, microbiology, immunoassay and cytology workflows and clinical performance. Similarly, coordinate closely with WW Director of Scientific Affairs to enhance BD’s image as a premier Molecular/Microbiology/POC immunoassay/Cytology leader, enhancing that image by delivering World Class assays in the clinical IVD infectious disease spaces.
Coordinate product development objectives with peer functional leaders, especially in the Medical, Regulatory, Quality, Finance, Manufacturing and Marketing functions.
Perform strategic and technical assessment of external technologies at target companies for partnering and potential licensing and acquisitions.
Professional Experience and Qualifications The ideal candidate will possess the skills and a solid track record in developing and bringing to market nucleic acid based assays for infectious disease (bacteriology and virology) diagnostics using nucleic acid-based (DNA and RNA) amplification technologies for practice on human clinical specimens composed of many different types of sample matrices including urogenital tract, blood and blood derivatives, wound, oral, respiratory and nasopharyngeal origins. The candidate will also have a strong working knowledge of bacteriology and be highly familiar of classical and emerging technologies of rapid methods for detecting bacteria or viruses direct from clinical specimens including blood, urine, wounds and other clinical specimens.
The candidate will have a superior working knowledge of (NAAT) Nucleic Acid Amplification Technologies including real-time fluorescent PCR, (isothermal) and other emerging DNA/RNA amplification technologies.
The candidate will have significant training or experience in microbiology and immunochemistry for bacterial detection, classification, and susceptibility and resistance determination.
The candidate will be able to leverage and nurture(internally/externallyacquired) technological knowhow gained through internal capability building, collaborations, KOL relationships, and other leading edge sources to develop and leverage world class capabilities all facets of Molecular Diagnostic assay development.
The candidate will be able to demonstrate excellence in sample preparation, DNA/RNA isolation and extraction chemistries and methods, amplification enzymes, amplification and detection methods (including melt chemistry, arrays, etc.) and general nucleic acid amplification system technologies to create competitively differentiable assay products on BD’s platforms.
The ideal incumbent will also possess deep clinical knowledge relating to Infectious Diseases(bacteriology/virology)and will be able to drive strategy creation on the creation of clinically and competitively relevant assays with the business leaders and platform teams.
The ideal candidate will havecapability/experienceand mentoring/coaching skills to develop BD’s next set of leaders in R&D. The ideal candidate will have the capability (learning agility) to grow into the next level of R&D Leadership within the BD Diagnostics Systems or the BD Life Sciences Segment within 3 years.
Essential Requirements + Ph.D. preferred in Biochemistry, Molecular Biology, Microbiology, Immunology.
Infectious Diseases training preferred with related work experience in the Clinical Infectious Disease Diagnostics arena.
Deep Molecular training (PhD), but the ideal candidate will be an MD or have significant infectious disease clinical experience, (dual training in microbiology), or closely related discipline to assure development of best in class, clinically relevant assays, molecular and microbiology, immunoassay design/development methods, assay design, etc. based on emerging clinical needs (globally) for HAI’s, TB, STI’s, viral diseases (respiratory, HIV, HCV, HBV, et.al.), developing world diseases, and potentially oncology.
At least 15 years of applicable managerial experience in R&D management at a suitable leadership level with strong people development and delegation skills.
Has managed a large R&D organization developing NAAT assays, or microbiology assays with recent molecular R&D assay development track record, and has taken that organization to the next level of performance, demonstrating the ability to develop multiple assays or systems at once to meet the criteria of our syndromic approach (assay bundles) to product development. Has demonstrated the ability to put together an excellent (productive = right first time) teams. Has demonstrated ability to work within a matrix structure, with knowledge of molecular and microbiology IVD assays and component manufacturing methods, rare reagent sourcing, clinical evidence generation, and IVD regulatory guidelines on Molecular/Microbiology/Immuno/Cytology products. Is recognized as a solid team player in the industry.
Demonstrated strategic mindset to complement (and/or constructively challenge) our business leaders on infectious assay strategy (can spot and create solutions for unmet needs in the IVD market), and is able to readily offer novel technology solutions to difficult business, platform, or technical problems.
A high profile (or emerging) professional in the IVD industry or the clinical community, is comfortable to speak in public meetings on behalf of BD and other forums that benefit BD’s presence in the market for molecular (AACC, AMP, ASM, Eurogin, etc.), Micro (ASM, ECCMID). Can exemplify the benefits of BD’s designs/products in Molecular, Microbiology, Immuno, and Cervical Cytology, both from an assay and systems aspect in meetings, i.e. with FDA and other regulatory or medically related discussions with external parties.
Can further BD’s strategic messaging and credibility surrounding Molecular Assays, Microbiology assays and methods, Molecular and Microbiology automation, screening, molecular POC, and other vectors of penetration in the market categories.
Possesses an existing personal professional network in the industry from which s/he can attract talent and develop meaningful collaborations to accelerate BD’s agenda going forward. Has published and is a recognized name in the Infectious Disease Assay R&D field.
The ideal candidate possesses a clear proven track record of developing high performing Infectious Disease assay products and a strong record of accomplishment in the field. Ability to manage multiple organizations and assay research/development projects with clear articulation of prioritization of resources with focus on successful outcomes. # Primary Work LocationUSA MD - Baltimore # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status
Scientist, Assay Development
About Nuredis Nuredis, Inc. discovers and develops small molecule therapies for a group of inherited neurodegenerative and neuromuscular diseases, aiming to treat the cause of disease rather than just managing symptoms. Nuredis was founded in 2016 based on technology licensed from Stanford, with facilities in Menlo Park.
Nuredis is looking for a self-driven candidate who will be an integral member of our dynamic and highly motivated research team, to make significant contributions to therapeutic development. Job Description The current position to be filled is Scientist, Assay Development. The candidate will be expected to develop and perform in vitro assays such as ELISA and cell-based assays to determine therapeutic efficacy of small molecules in our therapeutic pipeline.
In addition, the candidate will be tasked to develop new assays to measure biochemical markers of therapeutic effects to be used for clinical trial purposes. The work scope includes developing, validating, and performing ELISA assays, running cell-based assays and DNA-based assays to evaluate drug efficacy. Setting up SOP, documenting experimental processes and generating reports will also be key duties.
Minimum Qualifications •Ph.D. in Molecular Biology, Biochemistry, Cell Biology, Genetics, Chemistry Neurobiology or related fields with 5+ years of post-graduate experience in developing and/or validating protein assays such as ELISA and cell-based assay development •Experience in DEVELOPING and PERFORMING ELISA assays to evaluate small molecule drug candidates; specifically, establishing assay parameters such as specificity, selectivity, quantification limits (LLOQ), linearity, and reproducibility •Ability to design experiments and think independently with minimal supervision •Ability to work as a productive member in a dynamic and highly collaborative team; high level of energy, enthusiasm and initiative, good communication skills •Must be legally authorized to work in the United States Additional Qualifications Candidates with direct experience in the following areas will be given priority. •Experience in overexpression and purification of large intracellular proteins from mammalian cell culture •Experience in making monoclonal antibodies •Experience in handling human blood samples •Experience in animal studies •Experience in fields of neurobiology or neurodegenerative diseases •Basic statistical analysis of data •2+ years of work experience in Biotech or Pharma industry is preferred Application Instructions To apply, please email your cover letter and resume to , with the subject line "Nuredis Application: Scientist, Assay Development"
Post a Job
Biomolecular Assay Research Associate Or Scientist
Who We Are
Alveo Technologies is changing the world by applying cutting edge advances in sensing, microfluidics and bioassays to create the next generation of point of care infectious disease and personal care diagnostic devices. We are connecting and empowering consumers, healthcare professionals and treatment providers with personalized medicine. Our versatile product platform enables rapid, inexpensive and dependable screening in the waiting room, doctors’ office, at home or any low resource setting. We are hardworking, encourage the input of all members of the team and value a healthy work-life balance.
Strongly self motivated with a desire to grow by working as part of a highly-collaborative, multidisciplinary team in a fast paced setting. Must be meticulous, focused and detail oriented while working smoothly and efficiently with minimal supervision. Tidy work habits considerate of colleagues are essential. Independent, flexible, enthusiastic and professional. Excellent communicator, team player, highly organized and a fast learner. Mechanically minded individual with experience operating prototype devices/instruments is a plus.
- Design, perform and optimize nucleic acid and immuno assays for clinical samples
- Test assays on Alveo’s prototype and beta unit platforms
- Write and review technical reports to clearly communicate experimental results and challenges
- Identify, analyze and appropriately interpret relevant scientific literature
- Define objectives, collect and analyze data, and draw meaningful conclusions
- Effortlessly manage multiple tasks and prioritize duties effectively with limited oversight
- Assist in maintaining operation of lab including cleaning and ordering consumables as needed
- Bachelor’s degree (BS), Master’s (MS) degree in biological/analytical science or equivalent work experience
- Track record of designing, executing and optimizing nucleic acid assays
- Highly skilled at pipetting with track record of routine success in executing complex experimental protocols
- Track record of successfully working at the bench as part of a team
- Experience working in strict, biosafety level 2 (BSL-2) environment
- Willingness to work with infectious or otherwise biohazardous material
- Experience with basic molecular biology techniques including PCR, gel electrophoresis, immunoassays, etc
- Interest in learning new skills and ability to quickly master unfamiliar tasks
- Ability to work successfully both independently and in a collaborative environment
- Excellent written and verbal communication skills (English) as well as ability to communicate effectively with scientists and engineers from a wide range of technical backgrounds
- Flexibility to perform duties while working in a rapidly evolving environment
- Comfortable using common office software (Microsoft, Google, etc)
- Master’s (MS) degree in biological/analytical science or equivalent work experience
- 2 or more years hands-on laboratory experience
- Experience using prototype microfluidic platforms
- Experience designing, running and analyzing nucleic acid amplification assays
- Experience working with RNA samples
- Experience working with blood, human pathogens and biohazardous material
- Expertise developing immunoassays (i.e. ELISA) from scratch (not kits)
Health insurance, 401k, commuter benefit, mobile phone subsidy, flexible time off, free on-site gym, healthy snack day, fun team building activities, fencing and basketball.
Primary candidates ONLY. No recruiting agencies.
Research Associate, Bioanalytical Assays
Typical Daily Work Hours = 8am to 5pm (some flexibility in start/end times)
Weekend & OT work not required, but will be available, so all candidates should be open to it.
100% onsite work.
CORE JOB FUNCTIONS
- Responsible for carrying out laboratory experiments and analysis in support of characterization/qualification, validation and/or transfer of analytical methods.
- Conduct experiments/analysis independently and may assist other scientists/analysts with experiments employing various methodologies, including: cell culture, flow cytometry, ELISA, cell counting, qPCR, etc.
- Draw basic conclusions from data and results and communicate effectively within/across groups.
- Contribute to scientific technical writing of qualification, validation and/or transfer plans and reports.
- Perform instrument/method troubleshooting and investigations within analytical method parameters and management guidance.
- Use laboratory notebooks to document laboratory experiments in compliance with cGMP requirements.
- Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices.
- Provide training for analytical release and stability assays.
- BS/MS in Biology, Cell Biology, Biochemistry or relevant discipline with equivalent experience.
- Ideally a minimum of 2 - 4 years recent laboratory experience.
- Experience/knowledge with flow cytometry, ELISAs, microbiology, cell culture, qPCR.
- Basic understanding of analysis software, experience in statistical design and analysis of experiment is a plus.
- Understanding of basic experimental design and scientific reasoning.
- Experience in assay transfer, instrument performance qualification, training or technical writing is a plus.
- Highly motivated, willingness to acquire new skills and ability to work with minimal supervision.
- Must be proficient in MS Office suite of software.
- Good communication skills.
- Able to work well in team environment to achieve results.
Our founders are seasoned business frontrunners with business process outsourcing backgrounds and proven track record in the finance and IT field.
Our leaders are pioneers in the Philippine RPO scene catering to US-based clients and play an integral role in supporting our recruiters ensuring the success of each campaign.
As pioneers in the Phillipine RPO business, we invest on our talents harnessing cum laude graduates from top universities and seasoned recruiters having 5+ years of experience in offshore staffing.
24HRPO focus not only in cost savings: but more importantly we work on making our partners generate more revenue by allowing them to cover more Job Orders, more clients and more placements. We invest in building long term business relationships with a high flexible engagement model.
- MS or PhD in Biological Sciences (e.g. microbiology, biotechnology, immunology, cell biology, biochemistry).
- 5+ (PhD), 11 (MSc), years’ experience in a microbiology laboratory and diagnostic product development
- Demonstrated record of competence in performing microbiology assays in a regulated environment is required. Experience with isolating, growing and maintaining bacterial, viral, protozoan and fungal cultures
- Facilitate the understanding and transfer of key diagnostic development processes / products / information into the manufacturing, commercial and regulatory functions.
- Experience with development of IVD’s, CE marking and the 510(k) submission process are desired.
- Strong knowledge of immunoassay methods used for protein analysis, with hands-on experience in at least one of the following assay formats: EIA, bead-based assay (e.g., Luminex platform), or ECL is required.
- Working knowledge of statistics, Design of Experimentation (DOE), the Six Sigma method, risk analysis (FMEA, Cause and Effect, Fishbone Diagram, etc.) is desired.
- Good understanding of Good Laboratory Practices (GLP), Quality System Regulations (QSR), and International Organization for Standardization (ISO) is required.
- Demonstrated proficiency with Excel, PowerPoint, and Word programs is essential.
- Must have excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical scientific information to a wide range of audiences.
- This is a hands-on, bench level laboratory position that includes supervising the work of other laboratory scientists and associates.
- Conduct experiments on patient specimens; analyze human specimens (blood, urine, feces) for specific analytes to monitor and identify microorganisms using Singulex or other assay technologies.
- Set up a microbiology procedures and ensure a safe and compliant laboratory environment.
- Grow and maintain bacterial, viral, protozoan and fungal cultures.
- Develop, optimize and validate assays for the Singulex Clarity® System and for other platforms as necessary. Optimize new assays, processes and scaling up to achieve commercial levels of stability, robustness, and performance. Develop and execute systems integration plans for the assay involving automation.
- Supervise and train junior personnel; plan and coordinate experiments and review data of junior personnel. May have direct reports and be responsible for mentorship, guidance, and writing performance reviews
- Support assay troubleshooting, root cause analysis, process improvement, reagent formulation, guard band and stability studies.
- Critically analyze, summarize and report data generated from experiments, draw conclusions from experimental results, recommend and execute follow-up actions with consideration of prior experimental findings (self and others) with minimal supervision.
- Propose new investigations based on experimental findings and literature review. May be involved in feasibility studies to define assay parameters and verification and validation studies to support regulatory requirements.
- Demonstrate a comprehensive understanding of the technology encompassed in and practiced with the Singulex assays as well as other assay platforms employed by Singulex, Inc., and understand general immunoassay principles. Apply knowledge of scientific principles and concepts to develop assays and processes.
- Demonstrate success in technical proficiency, scientific creativity, collaboration with others and be able to work independently. An emerging leader who demonstrates expertise with the Singulex technology and components involved in the Singulex immunoassay system.
- Present data at team meetings or to small focus groups that may include representatives from other departments and/or outside parties. Participate in and lead brainstorming and troubleshooting sessions.
- May represent the Company in external relationships including communications with instrument manufacturers, suppliers of critical components, potential partners and evaluation sites.
- Ensure compliance with and implement the requirements of working in a regulated environment to assure adherence to various requirements including Design Control, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
- Follow the Singulex Design Control process for Product Development, and document all work as required by this process. As part of a team effort, be involved in the planning, and perform and document verification activities to ensure that newly developed products meet the pre-determined product specifications and all applicable requirements of the Food and Drug Administration (FDA), QSR, ISO, and CE mark. Generate, document and review studies related to the verification, validation, and transfer of assays under development.
- Ensure maintenance of appropriate laboratory records, notebooks, QC and manufacturing documentation as required for self and direct report(s).
- Facilitate the transfer of Assay Development processes to Singulex Manufacturing and CMOs, including involvement in the completion and release of enabling documentation for newly developed products by ensuring all relevant technical information is incorporated into the appropriate documents
- Maintain knowledge of current technology-related information, literature and theories. Demonstrate scientific creativity, innovation, and understanding of the principles, requirements and practices of Assay Development.
- Conduct project related information searches, literature searches, and may be involved in review for project specifications and initiation. May contribute to scientific publications, posters and conferences, when appropriate.
- Train individuals from own and other departments in laboratory procedures and processes as required.
- Coordinate general laboratory tasks such as laboratory cleanup and organization of work. Prepare reagents as required and maintain laboratory inventory. Perform other duties and assume additional departmental responsibilities as required. Perform other assignments and tasks as directed.
- Operate lab instruments according to procedures and assist in their routine maintenance. Writes operational procedures for new instruments.
- May be required to work non-standard hours; for example, second shift and some weekends.
- Normally receives no instructions on routine work, minimal instructions on new assignments, and detailed instructions or training on new applications or responsibilities.
- Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Excellent cross-functional team leadership and participation skills.
- Consistently displays a positive, patient attitude and extends respect and courtesy toward supervisors and peers alike.
- Highly organized and detail-oriented.
- Results and goals oriented.
- Excellent written and oral communications.
- Ability to work in a fast-paced and changing environment
- Flexible and quickly adaptable to changing priorities.
- Good people skills. Ability to supervise team members and work with a positive attitude, control negativity, and promote teamwork at all times.
- Ability to inculcate the Singulex “Top-5” core values and serve as positive example to team members and others within the organization.
- Effective interpersonal communication skills.
- Excellent training skills and shares knowledge.
- Having integrity and a strong work ethic.
- Passionate for both personal and corporate success.
- Ability to work independently with minimal supervision and as a member of a team.
- Commitment to quality.
- Enthusiasm, attention to detail, the ability to meet aggressive deadlines, ability to think “out of the box,” and ability to work effectively with others in a fast paced, highly-productive environment.
Singulex is a commercial stage, privately held company pioneering Next Generation immunodiagnostics (NGI). Singulex’s proprietary Single Molecule Counting technology is the back bone of NGI, and provides unprecedented ultra-sensitivity in the precision measurement of biomarkers. Such reliable ultra-sensitive accuracy provides definitive health status answers for physicians and patients resulting in improved health outcomes and reduced healthcare cost, without reducing delivery of care. Powered by SMCTM technology, the company’s NGI commercial offerings are transforming patient care from reactive disease treatment to proactive health management.
B And T Cell Assay Group Lead, Biologics Discovery
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, located in Spring House, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives.
We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Biotech, Inc. delivers on the promise of new treatments and ways to improve the health of individuals with serious disease.
Built upon a legacy of innovative firsts, Janssen Biotech pursues advancing patient care with immunology and oncology solutions. Please visit http://www.janssenbiotech.com/ for more information. We are Janssen.
Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. JBio, Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, works on projects from five therapeutic areas and enables discovery of new therapeutics concepts in collaboration with Therapeutic area discovery counterparts.
Utilizing highly specialized, world-class expertise, experience and knowledge, this position will be accountable for the development and implementation of a B and T cell biology strategy to allow Janssen Pharmaceutical Research and Development to become leaders in the discovery and development of therapeutics targeting these cell types and their activities, focusing mainly on immunological diseases and oncology. Key responsibilities include, but are not limited to: + Leading multiple complex cross-functional and cross-company preclinical and clinical projects to develop and deliver best-in-class biotherapeutics targeting B and T cell function
Designing and executing strategies to take advantage of cutting-edge innovative scientific discoveries that will deliver industry leading clinical products and platforms + Managing scientifically diverse team of scientists toward execution of product and platform development + Collaborating with therapeutic area leads to define and co-develop future projects and programs + Utilizing clinical development experience to identify opportunities to achieve robust clinical proof-of-concept that is differentiated from competitors + Contributing to regulatory communications, submissions, and participate in meetings with Health Authorities in US and Europe and with key opinion leaders Qualifications + BS with at least 20 years of assay development, immuno biology or drug discovery experience OR a MS with at least 15 years of assay development, immuno biology or drug discovery experience OR a PhD with at least 10 years of assay development, immuno biology or drug discovery experience is required + At least 5 years in B and T-cell biology is required + Demonstrated leader in the field of B and T cell biology is preferred + Significant experience in biotherapeutics is required + Possess the ability to independently propose, design, execute and report research projects + Experience in early drug development is required + Team leadership (coaching, mentoring, leading projects, directly supervising) is required, and experience in a heavily matrixed environment is essential.
Ability to travel up to 10-15% yearly is required (International as well as Domestic) is required Primary Location United States-Pennsylvania-Spring House Organization Janssen Research & Development, LLC. (6084) Job Function Biology Requisition ID 9412170831
Staff Scientist - NGS Assay Development
The Sequenom division of LabCorp, focused on women's healthcare tests and non-invasive prenatal testing (NIPT) has an exciting opportunity for a Staff Scientist to join its R&D Diagnostics Development Team! The Staff Scientist will plan and execute assay development experiments and projects including those for innovative programs like liquid biopsy.
The ideal candidate will have extensive knowledge of molecular biology and biochemistry as well as a proven track record in development of novel nucleic acid detection assays. Experience with the analysis of genomic data, in particular NGS and/or microarray data, is preferred. Understanding of the biology of cancer and low frequency variant detection is a plus. This is an exciting opportunity to be part of a dynamic R&D team and have the opportunity to participate in novel technology development.
Responsibilities: + Design assays and experiments, execute experimental protocols, and analyze data for review + Contribute to the team focusing on liquid biopsy and other molecular diagnostic assay development
Develop next generation sequencing assays and perform data analysis/interpretation
Develop target enrichment approaches utilizing multiplex PCR and/or capture methods + Conceive and design model systems for proof-of-concept studies + Design and execute appropriate analytical verification studies + Document all work in the form of laboratory notebook, study reports, summary reports and presentations + Perform data analysis with graphical representations of findings using appropriate software (R, Excel, JMP) + Present data clearly and concisely at departmental meetings and project meetings + Participate and present findings at conferences + Publish scientifically relevant data in peer reviewed journals + Participate in the development of patent applications, if applicable + Independently and/or collaboratively conceive, initiate, and apply for the acceptance of new projects
Cell-Based Assay Development Associate Investigator/Investigator
Job Description: s: ScitoVation is dedicated to understanding how chemical compounds affect human health and developing non-animal based approaches to human safety assessment.
We help our clients develop safer and more effective pharmaceuticals, food ingredients, agricultural chemicals, commodity chemicals and consumer products through the development of fit-for-purpose, human cell-based in vitro assays and computational models. We are seeking a cellular/molecular biologist to lead research in the design, development, and validation of cell-based assays for the evaluation of toxicological endpoints relevant to safety science. The candidate should have a combination of experience in general molecular biology techniques, cell culture methods, application of simple 2D or 3D cell models or more complex organotypic systems, and high-throughput assays.
The successful candidate for this position has a doctoral degree in cell biology, genetics, molecular toxicology or a related field with significant background in cell and molecular biology. A demonstrated track record of managing multiple projects, supervising technical staff, and writing proposals for external research sponsorship is strongly preferred. Expertise in in vitro alternatives for the following toxicity endpoints are of particular interest: primary hepatocyte culture and liver toxicity, developmental toxicity, endocrine disruption (thyroid, androgen), cardiac, brain and kidney toxicity. Required Experience: + A PhD in molecular biology, cell biology, pharmacology, molecular toxicology, or similar disciplines is required + At least 2 years of work experience post-graduate studies + Experience in phenotypic assay development or optimization for medium or high-throughput screening + Experience with advanced techniques such as organotypic or 3D cell culture model systems, high content imaging and/or flow cytometry for high throughput assays is preferred, but not essential + Independently managed multiple projects and personnel + Self-driven individual with strong organizational skills + Excellent communication skills - both verbal and written
- Ability to work in a team environment and guide research to support overall company goals Keyword: Cellular Molecular Biologist Cell Assay Cell Models Toxicity Toxicology PhD 3D Cell Culture Flow Cytometry Pharmacology From: SciMetrika
Assay Product Specialist I
Collaborative, assertive, flexible, passionate, driven, inspired. These aren’t just nice words, they’re the start of every great Fluidigm career.
We are a growing community of thinkers and creators, dedicated to pursuing the fundamental truths of biology. We seek to empower and inspire our customers and each other to push limits and envision ever more creative answers to “what if…?” As the industry pioneer in revolutionary single-cell technology and a cutting-edge leader in production genomics, we are committed to enabling biological exploration at every level. And if you’re into all that too, we’re ready to commit to you.
Fluidigm is looking for an Assay Product Specialist I for our Assay Design Group. The team member will focus on providing design service support to customers and internal teams to ensure timely execution of customer orders. Job duties include management of multiple customer designs and ability to troubleshoot problematic designs.
You Are: + Passionate about working for a company that creates cutting edge scientific solutions + Inspired by the opportunity to help develop high quality reagents for Fluidigm’s platform. You Will: + Provide technical expertise to customers in the development of genotyping, gene expression, and targeted re-sequencing primers + Manage multiple customer projects in designated sales territory + Perform necessary wet-testing protocols for project fulfillment + Provide assistance to support and sales teams in regards to customer projects + Maintain records and laboratory environment to comply with regulatory requirements, good laboratory practices, and standard operating procedures.
Any other Manufacturing Operations duties as assigned. You Have: + Bachelor’s degree in Biology, Biochemistry or similar Life Science.
Technical proficiency in molecular biology enabling independent and effective execution of lab protocols.
Experience with publicly available informatics tools, e.g. UCSC Genome Browser, Primer3.
Experience in PCR primer design a plus.
Working knowledge of MS Office, Excel, Access and general understanding of ERP concepts.
Ability to pick up new technologies quickly and ultimately troubleshoot independently.
Ability to multitask in a fast-paced environment. Working Conditions: + May require handling and use of hazardous materials.
Acute judgment is expected in handling such materials. Repetitive motion tasks or projects may be assigned. Lifting typically does not exceed 25 pounds. Environment is climate-controlled.
No travel is required for this position. We Will: + Support you in your ongoing development and contribution both as an employee and as a person.
Value your contribution and enlist your feedback + Host excellent company-wide events multiple times a year Sound good? Apply online now with your resume.
Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, age, or national origin. Req No.: 2017-2496 External Company URL: https://www.fluidigm.com/
Associate Scientist, HTS Assay Development
Description: Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Scientist, High Throughput Screening Assay Development, located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit for more information. The new Lead Discovery team is a critical part of the Discovery Sciences (DS) organization in Janssen R&D, and is committed to the delivery of high quality chemical leads needed for the generation of small molecule clinical compounds in all five Janssen Therapeutic Area (TA) discovery teams.
This mission requires deep scientific expertise in a number of disciplines including chemistry, cellular and molecular pharmacology, enzymology, and screening technologies coupled with an ability to work collaboratively with internal and external partners. Building on a strong legacy of success, we are currently seeking an outstanding individual to join our team as Associate Scientist in the Lead Discovery group. This position will be based in Spring House, PA.
You will be a key member of the High Throughput Screening group and provide analytical support and expertise to therapeutic area programs from target nomination through declaration of a clinical candidate. You will also: •Design and perform biochemical or cell-based screening assays for HTS and Lead Generation •Utilize automation in the performance of HTS assays •Communicate results to project team members •Collaborate with Therapeutic Area scientists Qualifications: •A minimum of a Bachelor's Degree in biochemistry, cell biology, chemistry or related areas is required. •A Master's degree in biochemistry, cell biology, chemistry or related field is strongly preferred. •Expertise using methods such as luminescence, fluorescence, absorbance or radiometric detection assays to analyze biochemical or cell-based data is required. •Experience with biophysical methods such as surface plasmon resonance, microscale thermophoresis, isothermal titration calorimetry or mass spectrometry is preferred. •Experience in the design, optimization, and miniaturization of biochemical or cell based assays for High Throughput Screening is preferred. •Familiarity with modern automated laboratory instruments for running high throughput assays is preferred. •Strong capabilities to collaborate with scientists in multiple disciplines is required. •Excellent written and oral communication skills are required. •Excellent quantitative analytical skills and familiarity with best practices in biochemistry and cell biology is also required. •Record of publications is preferred. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location: North America-United States-Pennsylvania-Spring House Organization: Janssen Research & Development, LLC. (6084) Job Function: R&D Travel 0-10%
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