Nonclinical Study Management and Operations Specialist
TOP 3 Skills:
– Toxicology/DMPK in vivo research experience, direct experience managing or monitoring studies highly desirable
– Basic understanding/familiarity with pathology phase of studies and QC procedures
– Excellent communication, negotiation and organizational skills
Description:
We are looking for a collaborative, enthusiastic partner to provide planning, coordination and execution of nonclinical safety assessment and DMPK activities that support drug discovery and drug development programs across therapeutic areas.
Primary duties include:
• Primary responsibility for Contract Research Organization (CRO) vendor management, including CRO technical evaluation, contract development, and contract management.
• Assist project representatives in nonclinical study start-up and maintenance activities. Specific tasks include communicating with contract research organizations (CROs) for quotes, facilitating contracts, compound management, coordinating and tracking sample shipments/receipt, verifying invoices, SEND data set coordination, monitoring studies, CRO site visits, QCing documents (protocols, reports) and maintaining file systems for accuracy and completeness.
• Assist pathologists in maintaining the site pathology function and completing pathology studies. Specific duties include slide specimen management (receipt, inventory, return), slide scanning, QCing documents and document management.
• Assist in Departments’ finance/contracts/SOWs processes, specific duties include drafting budgets and reforecasts, initiating and tracking master service and confidentiality agreements, generating purchase orders, tracking and processing invoices for payment, and accounting for monthly spending and accruals
• Provide administrative assistance by arranging/executing domestic and international shipments and associated paperwork, coordinating and tracking archive requests, coordinating/planning/recording events, meetings and visitor schedules, and reviewing and processing documents.
Requirements:
Bachelors of Science with study in a field related to biomedical research (ex pharmacology, toxicology etc); minimum of 4 years of relevant work experience in the pharmaceutical/biotech industry or at a CRO.
Experience in design and execution of in vivo studies is highly desirable. Basic knowledge of the drug development process, and SEND and GLP requirements for nonclinical studies a plus.
Intermediate to advanced proficiency using Microsoft Word, PowerPoint and Excel
Ability to travel within North America up to approximately 10% (CROs) and availability for occasional early morning and evening virtual meetings is required.
Team player who thrives in a fast-paced environment and takes the initiative to identify, analyze and resolve issues.
Source: Job Diva – Job Listing
The Creator Management Operations Specialist will oversee the migration of our data into customer relationship management (CRM) tool and work with our product team to drive more value to our Pinners and Creators. This role will work with cross-functional teams including product, international teams, and partnerships to support various initiatives to drive Creator value. This will be a 6 month contract, based in San Francisco.
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Source: Job Diva – Job Listing
See the attached Job Description Document and the Skills and Experience section for details.
See the attached Job Description Document and the Skills and Experience section for details.
Source: Job Diva – Job Listing
Duties
The candidate will participate in drug product development of non-viral (nanoparticle based), viral vector- and cell-based gene therapies. The selected candidate will be responsible for formulation and process development (formulation screening, container closure selection, process development and scale-up of liquid, frozen, and lyophilized drug product, stability studies), and assay development to support all phases of the programs. This position offers the opportunity to contribute to a variety of projects while serving as a valuable member of a multidisciplinary team. The successful candidate would be required to:
Develop and apply analytical methods to assess stability of non-viral, viral vectors- and cell-based therapeutics
Assist in developing new technologies in the areas of polymer-based drug delivery technologies and drug product process development
Troubleshoot problems and communicate solutions to project managers.
Utilize electronic lab notebook to document and compile data.
Present data in group and departmental meetings.
Maintain laboratory instruments.
Work independently as well as in a matrix environment.
Manage multiple projects to meet aggressive deadlines.
Train junior lab members
Skills
Preferred Qualifications
Solid understanding and practical experience in drug product formulation and process development of non-viral gene therapies: formulation development of lipid nanoparticles, liposomes and polymer conjugates for nucleic acid delivery, container closure selection, stability studies, in-use studies and process development of liquid, frozen, and lyophilized drug product. Theoretical knowledge and hands-on experience in analytical techniques: Fluorescence based nucleic acid quantitation assays (e.g. Ribogreen assay), HPLC/UPLC, capillary electrophoresis, gel electrophoresis, DLS, zeta-potential, DSC, DSF, UV, CD, Cryo-TEM.
Experience in formulation and process development of viral vector-and cell-based therapies is a plus. Experience in cell culture, flow-cytometry, qPCR, ITA, plate-based potency assay is a plus.
Basic understanding of statistical data analysis. Good written and verbal communication skills.
Education:
BS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 6 plus years of relevant experience or MS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 2 plus years of relevant experience
Source: Job Diva – Job Listing
Description:
Support ongoing manufacturing process and technical transfer projects for protein-based biopharmaceutical as part of the team.
Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
Responsible for defining and supporting continuing validation program, process improvements, support execution and documentation of development and/or validation studies and contribute to quality event investigations
Document and interpret study results with recommendations.
Provide technical leadership as a subject matter expert in multiple areas of responsibility.
Participate in developing process control strategies.
Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
Experience:
Expertise in downstream unit operation design typically used in biotech/vaccine manufacturing (harvest/clarification, UFDF, viral filtration and large-scale Chromatography).
Knowledge of computer software common to mission (Excel, JMP, Spotfire ) is preferred.
Strong experience in GMP environments.
Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Experience in equipment start-up, qualification and validation is preferred.
Education:
Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
Degree in sciences with 3 years large scale process operational support, scale-up implementation & validation experience.
Source: Job Diva – Job Listing
What you'll do:
Provide strong analytical, problem solving, and technical skills to effectively collect requirements, identify alternatives, and design and deploy quality solutions.
Support projects throughout the entire Sales development life cycle (including level-of-effort estimation, technical design, documentation, coding, testing, deployment, and support) Participate in the planning and analysis of business requirements for system changes and enhancements Communicate with Technical Architect and Business analysts to best understand the needs for the system.
Design and develop solutions on the Salesforce.com platform, using Apex programming language
Work with Salesforce.com Web Services APIs.
Troubleshoot and fix defects for planned releases and production issues Research and find opportunities to utilize SFDC best practices, guidelines to improve system productivity, scaling and monitoring
Skills: Experience we're looking for: 3+ years of hands-on work as a SFDC Developer 5+ years of professional work experience You are a Salesforce Certified Developer (PDI/DEV401, PDII/DEV501) certifications. You have an excellent understanding of Apex, Visualforce, JavaScript, and CSS. You have senior experience with Apex, Lightning Components, Visualforce, REST, APIs, and SOQL. You have a strong understanding of other related technologies (SQL, SOAP, HTML, etc). You have experience with Product Development Lifecycle and DevOps Tools like GIT, Jenkins, JIRA, ANT, Force.com IDE, etc. You are able to work independently, proactive identify challenges, and be accountable You have strong written/verbal communication skills and can reconcile system behaviors with business/functional requirements You have a business-first approach to building systems and applications. You care about the business impact of your technical work Preferred, but not required: You have experience using and integrating with Data Warehouse applications (ex. Redshift, Hive, Snowflake). You have experience with building, testing, and debugging advanced SQL queries.
Source: Job Diva – Job Listing
The Quality Engineer partners with multiple stakeholders across the organization, internally and externally to ensure the production of quality products. Responsibilities include collaborating with internal and external stakeholders when issues occur, including root cause analysis and process improvement conducted both internally and at the supplier; provide performance feedback through communication and auditing.
Job Duties:
Collaborates with cross functional team of Manufacturing Engineers, Quality Engineers, Buyer/Planners, Production and Procurement Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
Provides technical guidance and quality compliance for Supplier Quality engagement on products, subassemblies and parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and *** requirements
Collaborates with engineering laboratory and production functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs and analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.
Audits quality systems for development acceptance criteria (parameters based on product result).
May undertake root cause analysis of incidents requiring corrective action. Ensures that corrective measures and deviation meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
May be certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement.
Minimum Requirements:
Bachelors Degree
The ability to fluently read, write, understand and communicate in English
No prior experience required; however prior experience in an FDA regulated environment preferred.
Experience with Quality Management System
Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);Familiarity with medical device complaint files and quality records;nowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
Strong computer skills (including Excel)
Source: Job Diva – Job Listing
Duties:
The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices.
Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach.
Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
Minimum Requirements:
Bachelor's degree in Engineering
2 years of relevant experience in a regulated industry (FDA environment preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
Education:
Bachelor's degree in Engineering
Source: Job Diva – Job Listing
Plusses:
Source: Job Diva – Job Listing
Summary:
Currently seeking engineering candidates with electrical / electromechanical / mechanical experience for a long-term contract assignment to provide sustaining engineering support to cross-functional teams.
This position will provide R&D technical post market/life cycle product support to analyze and assess impact of manufacturing design and process change requests (cost improvements, obsolescence, corrective actions) of ophthalmic surgical instrumentation products (consoles and associated reusable and single-use accessories): Analyze and troubleshoot design and process changes, solve technical problems at system-level, PCB board or assembly-level and component-level, document impact on physical and functional design specifications, perform gap assessments and document product compliance to external medical device industry safety and performance standards (EN, ISO, ASTM, etc.). Provide review of complaint / adverse event data and risk assessments (in compliance to EN ISO 14971), assist in developing and reviewing technical file / design dossiers for regulatory submissions and registrations. Prepare technical product documentation including drawing revisions, Bill of materials, and engineering change orders (ECO).
This position will also support R&D development project activities required for compliance to new European Medical Device Regulation (MDR), including managing and reporting technical product data, materials remediation (for RoHS, REACH,SVHC compliance) labeling updates and technical file updates (required to maintain European registration (CE mark) and will work to assess and maintain product compliance to existing and future regulations and product performance and safety standards and reporting (IEC, EN, ISO, etc.)
Required:
Bachelor’s Degree or Associate Degree and 8 years of directly related experience
The successful candidate will be responsible for independently completing work requests and document change requests as assigned by engineering teams and management
5+years of experience ideally in the medical device industry
Experience with product Verification & Validation in developing and executing the protocols & reports at sub-system & system levels to support Optical, Electro-mechanical component End-Of-Life (EOL )projects
Experience in Medical Device Design Control including risk assessment, management and reporting
Experience with troubleshooting and redesign of devices to meet requirements redesign of devices to meet requirements”
Experience in systems engineering with a background in electro-mechanical and optical systems is preferred.
Knowledge of Wavefront technology and high definition 3-D digital visualization systems is preferred
Familiarity with PRO-E and other Windchill product data management applications is preferred
Familiarity with OrCAD PCB design tools for schematic capture and fabrication is preferred.
Experience with and knowledge of EMI/ EMC testing is preferred
Familiarity with Design Of Experiments is preferred
Excellent written and spoken communication skills
Demonstrate Good Documentation Practices
Proficient in MS Office applications including basic Excel skills
Source: Job Diva – Job Listing
SUMMARY:
Work with the clinical study team on study design, development and/or review of clinical study protocols.
Contribute to clinical trial design, protocol concept sheet and protocol development
Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others
Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables.
Perform post-hoc statistical analyses as needed.
May work on submission teams as a statistician and/or a programmer.
Generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
Will serve as lead Statistician on complex trials and across multiple studies.
Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans.
Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes.
Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed.
QUALIFICATIONS:
Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry.
Strong SAS programming skills.
Oncology experience is preferred.
Ability to effectively work on multiple projects
Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
Applies good judgment and leads problem solving within the team
Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus.
Source: Job Diva – Job Listing
The ideal candidate will join the BioProcess Analytics group and will work closely with upstream and downstream groups within the Biologics Development organization. This a laboratory position; the candidate is expected to apply a diverse array of analytical techniques to support in-process testing and develop new high throughput analytical methods
Basic Qualifications
BS or MS in Analytical Chemistry, Biochemistry or related field with 3-6+ years of practical experience in biopharmaceutical or biotech industry
Hands-on experience in the analysis of monoclonal antibodies and other protein biotherapeutics
Experience in methods development for protein and peptides using chromatography and electrophoresis separation techniques (e.g. HPLC/UPLC, SEC, CE-SDS, cIEF, and etc)
Knowledge and experience with Microsoft including Excel, Word, and PowerPoint.
Experience with Waters and Agilent software is highly desirable (e.g. Empower, OpenLab, and etc)
Preferred Qualification
Knowledge of upstream and downstream protein therapeutic development is desirable
Designs, interprets, and executes experiments and analytical procedures. Evaluates and defines appropriate approaches. Employs in-depth technical knowledge.
May oversee and train lower level researchers in performing established procedures.
Collaborates in research and development efforts and makes key technical contributions affecting the direction of the project.
Independent and self-motivated.
Excellent written, verbal communication and presentation skills
Exceptional organizational skills, attention to detail and ability to multitask
Adapt and respond well to change in priorities and tight timelines
Responsibilities
Responsible for in-process analytical testing including released glycan assay and electrophoresis
Execution of 20 high throughput analytical methods to support high volume testing
Ensure data quality and reliability, documentation, accurate data interpretation and reporting in scientific, professional and expert’s manners in support of decision making.
Prepare presentations, technical reports, SOPs etc. to support programs
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Develop and sustain optimum molding process for medical manufacturing device components
Develop injection molding process per the decouple scientific principles.
Run Projects from start to finish.
Inprove and troubleshoot areas in the molding department.
Plastic experience required. Master Molder certification preferred.
Decoupled Molding Principles
Project Management
Requires good communication, people skills to work well with other departments, customers.
10+ Year in Plastic Manufacturing Industry
Ability to write technical reports and prepare and make effective presentations
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
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