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Job DescriptionQuality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of QC Microbiology, responsibilities of the QC Microbiology Engineer I will include but are not limited to: Microbiological Testing: • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required, • Training in GxP/ GDP, Safety, • Minimum 0-2 years of experience or equivalent experience., • Microbiology testing or within the biopharmaceutical industry experience preferred., • Proficient with computer software; Microsoft Office, • Strong written and oral communication skills, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels, • Must be able to work during the weekend, holidays and as required by the company, • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer II The Quality Control Microbiology Engineer II will support two local sites serving as a support role to clinical and commercial production. The QC Microbiology Engineer II will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer II will include but are not limited to: Microbiological Testing:, • Growth Promotion, • Microbial Identification, • Sterility Testing, • Gram Stain, • EndotoxinEquipment Monitoring:, • Ensure equipment is in proper working conditions, • Ensure all equipment is properly maintained/calibrated, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Writing/conducting investigations pertaining to microbiological testing, • Develop and train QC Microbiology Engineer I personnel on relevant business processesREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 2-4 years of experience with microbiological testing or within the biopharmaceutical industry., • Training in GxP/GDP, Safety, • Proficient with computer software such as; Microsoft Office, • MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical writing skills, • Technical training ability, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Supervisory Responsibility, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • Employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator., • Duties, responsibilities, and activities may change at any time with or without notice.QC Microbiology Engineer III The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer III will include but are not limited to:, • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Supervisory Responsibility; Direct reports, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels., • Must have the ability to work in a team-oriented environment and with clients., • Must be able to work during the weekend, holidays and as required by the company

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Clinical Scientist Data Reviewer 6 month contract w/ renewal 3 days onsite in Jersey City, NJ We are seeking a Clinical Scientist Data Reviewer that will support the scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate technical skills and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor and supporter in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results. This role will be focused on the detailed and critical safety data review efforts from study start-up through final CSR. The Clinical Scientist Data Reviewer is a crucial role in analyzing and interpreting clinical trial data to ensure accuracy, integrity, and compliance with regulatory requirements. There is additional room for growth and leadership opportunities in this role. Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s). This may include: • Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team, • Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment), • Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables, • Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming, • Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct, • Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development, • Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate), • Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies, • Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs Qualifications • 6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor’s degree in a relevant scientific discipline., • Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred., • Experience within oncology preferred, • Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH), • Ability to manage multiple competing priorities with good planning, time management and prioritization skills, • Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions, • Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports, • Interact with key stakeholders across Clinical Development functional areas, • Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals, • Influence opinions and decisions of internal and external customers / vendors, across functional areas, • Problem solving, prioritization, conflict resolution and critical thinking skills, • Strong communication, technical writing, and presentation skills experience

Help shape the future of nuclear medicine! SOFIE is seeking a Product Development Specialist to lead the development, implementation, and validation of manufacturing and analytical methods for innovative diagnostic and therapeutic radiopharmaceuticals. In this role, you’ll collaborate closely with leading pharmaceutical partners to bring new products from concept to reality—ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212). If you’re driven by innovation and excited to make a tangible impact in the advancement of healthcare, we want to hear from you. Title | Product Development Specialist Location | Totowa, NJ Department | Radiopharmaceutical Contract Manufacturing (RCM) Reports To | Director, Radiopharmaceutical Contract Manufacturing (RCM) Shifts: 9am-5pm Compensation: $90,000-$100,000 ( based on experience and education) Overview The Product Development Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE, within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE’s pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 212). Essential Duties and Responsibilities  Develop protocols for the production and analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is expected that the development of these protocols will involve both the application of scientific principles, and rationales, and adherence to regulatory requirements.  Write clear Standard Operating Protocols (SOPs) for these protocols.  Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements.  Provide technical support and/or training for production staff at SOFIE sites, either remotely or on-site.  Write corporate exception reports and other regulatory documents, such as risk assessments, change controls, etc.  Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.  Install, qualify, and maintain laboratory equipment on site.  Validate existing production or analytical methods on existing or new equipment.  Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development and radiopharmaceutical production.  Perform release testing, according to SOPs, on other materials (e.g., raw materials for radiopharmaceutical production).  Maintain all qualification and validation requirements for entering ISO classified areas.  Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations.  Maintain accurate radiopharmaceutical production records and test/validation results.  Write reports, presentations, and other documentation summarizing experimental/production data.  Coordinate with the Radiopharmaceutical Contract Manufacturing team’s activities to reach defined objectives.  Liaise with our contract partners (e.g., biotech and pharma).  Other duties as assigned. QUALIFICATIONS  A degree in chemistry, engineering or natural sciences preferred but will still entertain applicants with relevant education and work experience. PhD preferred.  3-years’ experience preferred in radiopharmaceutical manufacturing and QC in a GMP or academic environment  Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). Experience with the use of automated synthesis modules and maintenance of automated modules required.  Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.  Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification preferred.  Efficient in the use of MS Office Suite required.  Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required.  Strong technical writing skills required.  Excellent organizational skills required  Ability to work various shifts and weekends required.  Travel: up to 25% domestically.

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionQuality Control Microbiology Analyst II, IIIAllendale, NJ QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology. • Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Writing/conducting investigations pertaining to environmental monitoring and testing, • Develop and train QC Microbiology Analyst I personnel on relevant business processesREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry., • GxP/GDP, Safety Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills., • Technical training ability., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company., • Must be able to handle the standard/moderate noise of the manufacturing facility., • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring., • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates data for batch release., • Participation in project/client meetings and communications, providing scientific and technical expertise., • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols., • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections., • Develop and train QC Microbiology Analyst II on relevant business processes., • Processing of purchase orders for outsourced testing and lab supplies., • Coordinates work orders.REQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • GxP/GDP Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityAll PositionsWorking Environment, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityPlease note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn. Responsibilities • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias, • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals, • Complete writing assignments in a timely manner, • Maintain timelines and workflow of writing assignments, • Practice good internal and external customer service, • Highly proficient with styles of writing for various regulatory documents, • Expert proficiency with client templates & style guides, • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects, • Contribute substantially to, or manages, production of interpretive guides, • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary, • Mentor medical writers and other members of the project team who are involved in the writing processRequirements, • At least 3 years of previous experience in the pharmaceutical industry, • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience, • The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline, • Substantial clinical study protocol experience, as lead author, required, • Experience leading and managing teams while authoring regulatory documents with aggressive timelines, • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus, • Understanding of clinical data, • Exceptional writing skills are a must, • Excellent organizational skills and the ability to multi-task are essential prerequisites, • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools, • Experience being a project lead, or managing a project team, • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus LtPXymlXil

Job DescriptionScientist – Engineer, MSAT The Scientist-Engineer, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets. This includes leading projects in process development, technology transfer and continuous improvement of our client's novel manufacturing processes. Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all. • Accountable for the design and execution of experimental studies in the laboratory, for example:, • Perform laboratory experiments for client projects, • Perform analytical testing for client projects, • Preparation and scheduling of laboratory equipment for experiments, • Provide technical leadership of client products during manufacturing and development, for example:, • Direct technical communication with clients during manufacturing and development, • Support manufacturing in identifying and resolving manufacturing process constraints, • Lead the generation of manufacturing and development documentation, for example:, • Generating experiment protocols and reports for development projects, • Generating draft batch records and other manufacturing documentation, • Generating manufacturing risk assessments, such as FMEA, • Perform data analysis to reach actionable conclusions, for example:, • Compile and analyze experimental data, • Present experimental data internally and externally to clients, • Supervise direct reports.REQUIREMENTS, • Bachelor's degree in relevant life science or engineering discipline, • Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols, • Demonstrated ability to deliver projects to specific timelines and budgets, • Experience in working effectively and delegating tasks in a team-based environment, • Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications, • Basic understanding of the technical principles, theories and concepts of cell therapy or similar products, • Aseptic processing, Good Manufacturing Practice (GMP), communication skills, specific process and analytical equipment, • This job may require occasional evening and weekend work.

Job Description ABOUT VITALIEF Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth. THE ROLE We are seeking a highly motivated and detail-oriented Master’s graduate to join our client’s dynamic neuroscience research laboratory as a Graduate Research Assistant. The successful candidate will contribute to a growing body of work focused on addiction, brain function, and behavioral neuroscience, playing a central role in manuscript development, grant preparation, data analysis, and general research operations. This position offers an exceptional opportunity for a student with a passion for translational research to gain hands-on experience in the scientific, analytical, and administrative aspects of academic research. COMPENSATION & WORK ENVIRONMENT • Location: Onsite role in a collaborative and supportive research environment in Newark, NJ., • Work Hours: Part-time, 20 to 30 hours/week (Flexible scheduling to accommodate academic commitments), • Duration: 12-month contract, • Manuscript Development: Draft, edit, and prepare scientific manuscripts for publication in peer-reviewed journals, including literature reviews, data interpretation, and figure preparation., • Grant Support: Assist in developing and editing grant proposals, supporting background research, and preparing preliminary data and figures., • Data Analysis: Perform data cleaning, statistical analyses, and data visualization using appropriate software tools (e.g., SPSS, R, Python, MATLAB, or GraphPad Prism)., • Research Coordination: Support day-to-day lab activities, including documentation, database management, and coordination of research timelines., • Literature Review: Conduct and synthesize current literature relevant to addiction and neuroscience to support ongoing studies and future grant submissions., • Master’s degree in Neuroscience, Psychology, Biomedical Sciences, or a related field., • Prior research experience in neuroscience, addiction science, behavioral research, or related disciplines., • Experience with academic/scientific writing and publication processes., • Familiarity with grant writing (NIH or foundation-level preferred) is a strong plus., • Background in statistical or computational data analysis methods, including experience with SAS or SPSS, and some experience with AI models development., • Excellent written and verbal communication skills; collaborative and comfortable working in a team-oriented lab environment., • Self-directed and intellectually curious, professional, reliable, and responsive to feedback., • Strong analytical and critical thinking abilities; high attention to detail and ability to manage multiple priorities., • Proficiency in relevant software for data analysis, literature management (e.g., EndNote, Zotero), and document preparation. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR GiCn07JkZC

Job Description ABOUT VITALIEF Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth. THE ROLE We are seeking a highly motivated and detail-oriented Master’s graduate to join our client’s dynamic neuroscience research laboratory as a Graduate Research Assistant. Employed as a full-time, fully benefited Vitalief team member, the successful candidate will support research on addiction, brain function, and behavioral neuroscience through manuscript development, grant preparation, data analysis, and general research operations. This position offers an exceptional opportunity for a student with a passion for translational research to gain hands-on experience in the scientific, analytical, and administrative aspects of academic research. WHY VITALIEF? • Contribute: to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture: with opportunities for growth and innovation., • Competitive benefits: including 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Market-competitive salary: commensurate with experience and academic standing., • Manuscript Development: Draft, edit, and prepare scientific manuscripts for publication in peer-reviewed journals, including literature reviews, data interpretation, and figure preparation., • Grant Support: Assist in developing and editing grant proposals, supporting background research, and preparing preliminary data and figures., • Data Analysis: Perform data cleaning, statistical analyses, and data visualization using appropriate software tools (e.g., SPSS, R, Python, MATLAB, or GraphPad Prism)., • Research Coordination: Support day-to-day lab activities, including documentation, database management, and coordination of research timelines., • Literature Review: Conduct and synthesize current literature relevant to addiction and neuroscience to support ongoing studies and future grant submissions., • Master’s degree in Neuroscience, Psychology, Biomedical Sciences, or a related field., • Prior research experience in neuroscience, addiction science, behavioral research, or related disciplines., • Experience with academic/scientific writing and publication processes., • Familiarity with grant writing (NIH or foundation-level preferred) is a strong plus., • Background in statistical or computational data analysis methods, including experience with SAS or SPSS, and some experience with AI models development., • Excellent written and verbal communication skills; collaborative and comfortable working in a team-oriented lab environment., • Self-directed and intellectually curious, professional, reliable, and responsive to feedback., • Strong analytical and critical thinking abilities; high attention to detail and ability to manage multiple priorities., • Proficiency in relevant software for data analysis, literature management (e.g., EndNote, Zotero), and document preparation. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR Lpz8bcrXgW

Job DescriptionQuality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology. • Environmental monitoring in controlled environments: Non-viable particulate monitoring; Active viable air monitoring, Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring: Ensure equipment is in proper working conditions; Ensure all equipment is properly; maintained/calibrated; Assist with routine laboratory testing; Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).REQUIREMENTS, • Associates degree in a science or relevant field required; Minimum 0-2 years of experience or equivalent experience. Environmental monitoring or within the biopharmaceutical industry experience preferred., • Proficient with computer software such as; Microsoft Office, • Strong written and oral communication skills, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Trained in GxP/GDP, Safety, • The QC Microbiology Analyst I must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position will report into the Manager of QC Microbiology., • Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring, • Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations, • Shipping of test samples and equipment to contract laboratories for testing, • Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Writing/conducting investigations pertaining to environmental monitoring and testing, • Develop and train QC Microbiology Analyst I personnel on relevant business processes.REQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry., • GxP/GDP, Safety Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, • Familiarity with ISO and EU standards, • Strong written and oral communication skills, • Technical training ability, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring., • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Analyst II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work ordersREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • GxP/GDP Trained, • Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experience, • Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityWorking Environment, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facilityPhysical Requirements, • The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period., • Must be physically capable to stand; walk; site; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear., • Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.