Lab Tech

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com. Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements.  The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments.  Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing.  Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation.   The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks.   This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience.    Responsibilities: Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols. Create and execute product/process enhancement, and new product/process development plans. Lead material/design/process changes and their implementation with well-documented research/analyses.  Process and analyze results, Author protocols and reports including engineering studies and design verification/validation activities. Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes.  Prepare samples as required for manufacturing, testing, or other evaluations and data analysis.  Participate in voice-of-customer (VOC) labs and other user needs assessments. Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes. Support process and product transfers to manufacturing or CDMOs. Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines. Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions. Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project or product support as needed to support Cresilon’s business objectives. Requirements Required Qualifications Education:  BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline.  Minimum 4+ years previous experience in an industrial environment with a BS degree.  (2 years minimum experience if advanced degrees). Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment. Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively.  Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills. Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time. Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills. Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements. Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required. Requires excellent written and verbal communication and presentation skills. Legal authorization to work in the United States is required. Physical Requirements include: Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training. Wear Appropriate Personal Protective Equipment (PPE): Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment. Ability to speak, listen, and understand verbal and written communication. Possesses hand-eye coordination and manual dexterity for delicate manipulations. Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects. Visual acuity is required for performing close and distant activities. Preferred Qualifications An advanced technical degree (MS or PhD). ·Lab experience in an industry setting within cGMP-regulated environments. Prior experience developing processes and scaling these up into manufacturing or CDMO Mechanical/electrical knowledge with the ability to troubleshoot processing equipment Six Sigma green belt or black belt certification preferred. Experience implementing process and quality improvements in a manufacturing environment Work experience with the medical device or pharmaceutical industries Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200. Working knowledge of FDA requirements as per 21 CFR 820.  Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications Paid Vacation, Sick, & Holidays Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5% Work/Life Employee Assistance Program Company Paid Life and Short-Term Disability Coverage Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Join Us in the Fight Against Alzheimer's Disease Psychosis! Are you or someone you care about dealing with Alzheimer’s Disease? We encourage you to take part in vital clinical trials focused on enhancing research and treatment options for this condition. We are seeking patient volunteers to help evaluate the effectiveness of a new medication for this purpose. The medication will be provided at no cost to you or your insurance. Participants will receive compensation for their time and travel, and if you refer a qualifying friend, you will earn a $100 bonus. Call 480-716-4590 Now! Or Apply Here To qualify, you must: ● Be a male or female, 55 - 95 years of age ● Be diagnosed with Alzheimer's Disease or probable Alzheimer's Disease ● Have a prior history of psychotic symptoms for at least 2 months prior to Screening WHY PARTICIPATE? ●Compensation: Get compensated up to $3,400, with no cost to you or your insurance! ●Comprehensive Support: Regular check-ins and assessments to ensure your health is a priority. Our trial is conducted by experienced healthcare professionals dedicated to your well-being. ●No-cost study medications: Study medications are given at no charge. Check out our other studies! ● Multiple Sclerosis ● Obstructive Sleep Apnea ● Excessive Sleepiness Due to Shift Work ● Narcolepsy and Idiopathic Hypersomnia ● General Anxiety Disorder ● Asthma Treatment ● Cardiovascular Risk Factor Study ● Future Studies AND MANY MORE! Chandler Clinical Trials (CCT) Contact us today at 480-716-4590 or visit us at https://chandlertrials.com/ for more details! Advancing Medicine Through Research!

Millennium Health LLC is an accredited specialty laboratory with more than a decade of experience in medication monitoring and drug testing services, helping clinicians monitor the use and misuse of prescription medications and illicit drugs. The testing is used by healthcare professionals to obtain objective information about patients’ recent use of prescription medications and/or illicit drugs and helps monitor the effectiveness of treatment plans. A scientist who develops clinical LC-MS/MS assays.  Independently performs original scientific research and develops appropriate analytical technologies.  Manages resources and timelines for the project team. The following are intended to be examples of the accountabilities for which the person in this position is responsible.  This position is not intended to be complete or all-inclusive and does not preclude management from assigning other or related functions for which the individual has demonstrated competency through performance. Technical leader who develops, manages, and independently executes the research and development plan, to design, develop, and validate high-quality LC-MS/MS  assays/products/technologies within pre-defined timelines. Provide formal/informal scientific mentoring within the project team. Applies technical and functional knowledge to design experiments and independently complete work within own project team, working on multiple projects in parallel. Acts as a technical and scientific resource within the organization. Draft, review, and complete technical documents required for various stages of product development. Maintain detailed experiment records in lab notebooks and follow SOPs in compliance with company guidelines. Ability to ensure HIPAA, Confidentiality, and Compliance policy, procedures, and standards are always adhered to. Ability to ensure administrative, physical, and technical cybersecurity controls are always adhered to. Regular and reliable attendance. Requirements MS in Sciences such as Biology, Biochemistry, Chemistry, or a related field. PhD. preferred At least 5 years of industrial experience, preferably in an R&D analytical laboratory. Extensive hands-on experience with LC-MS techniques, including sample preparation, chromatography, method development, data interpretation, and validation. Familiarity with GLP and cGMP environment, LIMS experience, and project management. Understanding the principles of statistical tools is highly desirable Demonstrated ability and proven track record of successful development of assays/products. Excellent writing and verbal communication and presentation skills. Strong team player in a multidisciplinary environment; fully committed to development timelines. Benefits Medical, Dental, Vision, Disability Insurance  401 (k) with Company Match   Paid Time off and Holidays  Tuition Assistance  Behavioral and Health Care Resources Potential Hiring Range: Salary Range:  $115,000 – $135,000 /yr. Salary offered is dependent on qualifications, experience, and geographical location.     Millennium Health is an Equal Opportunity/Affirmative Action Employer and E-Verify participant. All qualified applicants will receive consideration for employment without regard to race, color, creed, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. California Employee Privacy Notice - Millennium Health LLC https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

10x Genomics, Inc. in Pleasanton, CA seeks Document Control Specialist II. Responsibilities: Responsible for managing documentation and records generated during various processes in accordance with the organization’s procedures for commercial and operations functions, including: working closely with Production and R&D to support new production introduction, production batch record change control and BOM setup in electronic document and ERP systems; supporting new and existing documentation, such as SOPs, Work Instruction documents, and training program files; collaborating with subject matter experts to develop new training materials or improve existing documentation, as well as refining standard Quality Management System (QMS) documents; processing document changes, such as Engineering Change Order (ECO), Engineering Change Requests (ECR), and other quality records, adhering to ISO standards; creating and releasing documents, such as batch records, for New Production Introduction (NPI) launches throughout all phases of the release process, including writing Bills of Materials (BOMs) for setup in the electronic documentation and Enterprise Resource Planning (ERP) systems; optimizing all documentation systems, including but not limited to, the Learning Management System (LMS) training system, the PLM platform, and the ERP system; and other duties as assigned. Salary Range $90k - $110k. Education: Bachelor’s degree in Computer Science or related technical field (or foreign equivalent). Requirements: Two (2) years of progressive post-baccalaureate experience in job offered or related positions. Other special requirements: Two (2) years of experience in document control/solutions, electronic storage, and technical writing of content/documentation to meet company standards and target company needs; two (2) years of experience working with document management systems; and two (2) years of experience with PLM system integration. Qualified applicants must send resume to 10x Genomics, Attn: Jana Jensen, 6230 Stoneridge Mall Rd, Pleasanton, CA 94588 quoting job #DCSII.

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com. Description: The Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. S/he will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation including proto-type design and fabrication and data generation through designed experiments. The Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use. Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety. Lead cross-functional teams to develop new products, address design issues, and maintain existing designs. Apply strong problem-solving skills to find solutions to complex problems. Work independently to plan and schedule own activities necessary to meet project timelines. Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success. Lead the creation of design history file documentation through the new product development process. Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications. Generate technical protocols/reports to support device safety and efficacy. Invent/create concepts and designs and submit invention disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses. Author protocols and reports including development studies and design verification/validation activities. Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs. Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company. Manage part-time staff as a research leader and mentor for ongoing research projects. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project or product support as needed in order to support Cresilon’s business objective. Responsibilities may include other duties as assigned and as required. Requirements Required Qualifications BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline. A minimum of 4+ years of product development experience is required. A minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred) Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment. Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans. Experience leading complex product development initiatives from concept through release. Good working knowledge of anatomy and surgical procedures is required. Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills. Requires strong leadership skills, excellent written and verbal communication and presentation skills. Working knowledge of FDA requirements as per 21 CFR 820 Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required. Legal authorization to work in the United States is required. Preferred Qualifications An advanced degree (MS or Ph.D.) is highly preferred. Hands-on experience in product development with Class II and Class III medical devices. Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs. Working knowledge of ISO 9001, ISO 13485:2003, and ISO 14971:2007. Experience with IDE and PMA submissions. Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) Good understanding of statistical tools and validation/verification techniques. Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Competitive annual base salary range of $80,000 - $160,000, depending upon job level and qualifications Paid Vacation, Sick, & Holidays Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5% Work/Life Employee Assistance Program Company Paid Life and Short-Term Disability Coverage Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

10x Genomics, Inc. in Pleasanton, CA seeks Sr. Research Associate II. Responsibilities: The Sr. Research Associate II will be a part of the Molecular Biology team working closely colleagues in computational biology, software, chemistry, and microfluidics to optimize and evaluate new assays in spatial multi-omics. More specific duties include: supporting the method development and optimization of novel molecular biology assay schemes for the detection of analytes in situ; collaborating with scientists, engineers, and other researchers in the optimization and troubleshooting of different sample preparation protocols for effectiveness and improved detection of analytes in situ, including in situ assays of tissue section on microscope glass slides; planning, performing, and evaluating data of biological experiments to support, improve, and expand our highly complex and proprietary technologies, products, and solutions; developing procedures, writing technical reports, and maintaining accurate records through diligent experimental observations and data tracking; clearly communicating and presenting results of data and research findings for making critical design decisions; and other duties as assigned. Salary Range $121,264-$130k. Education: Master’s degree in Bioengineering, Biomedical Engineering, or related field (or foreign equivalent). Requirements: Two (2) years of experience in job offered or related positions. Other special requirements: Two (2) years of experience in performing complex multi-step experiments, including NGS library preparation, principle of sequencing technologies, and data analysis; two (2) years of experience in standard molecular biology techniques such as sample preparation, nucleic acid amplification and purification, qPCR, and DNA sequencing; two (2) years of experience in designing novel molecular biology assay schemes and computational analysis of next-generation sequencing data; two (2) years of experience in troubleshooting and optimization of assays; and two (2) years of experience using light and fluorescent microscopy. Qualified applicants must send resume to 10x Genomics, Attn: Jana Jensen, 6230 Stoneridge Mall Rd, Pleasanton, CA 94588 quoting job #SRRAII.