<h3>Job Description</h3>
Job Description
Note: 2 days onsite/week are required
Title : Senior / Principal Systems Engineer
The Principal Systems Engineer will support the product engineering efforts for FDA regulated medical device technology.&nbsp; They will support efforts spanning from creation of new systems, and well as manage ongoing projects within R&amp;D.&nbsp; They will work with a wide range of departments across various functions including manufacturing, hardware, mechanical, regulatory and quality to define, design, and oversee the execution of projects related to medical systems and accessories.
Key Responsibilities:
<ul>
<li>Represent Systems Engineering/R&amp;D on cross-functional teams, managing program and technical risks.</li>
<li>Drive the progress of System Engineering within an FDA regulated environment, ensuring compliance with internal quality requirements and regulatory standards for Class I/II medical devices (FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 62366).</li>
<li>Evaluate design tradeoffs, manage conflicts, and balance technical risks while maintaining acceptable levels of risk throughout the product lifecycle.</li>
<li>Work with New Product Introduction (NPI) to incorporate Design for Excellence (DFx) and lean manufacturing concepts.</li>
<li>Collaborate with various teams to define engineering and system integration plans and acceptance criteria.</li>
<li>Lead technical product risk assessment activities, ensuring appropriate mitigations are identified and implemented.</li>
<li>Lead failure analysis and troubleshooting activities throughout the product lifecycle.</li>
<li>Participate in comprehensive design and technical reviews.</li>
<li>Foster collaboration among cross-functional partners to ensure product designs meet organizational goals and stakeholder expectations.</li>
</ul>
Requirements:
<ul>
<li>6-10+ years experience in designing complex medical systems in a regulated environment, with technical leadership experience preferred.</li>
<li>Knowledge of FDA, EU, IEC, AAMI, and ANSI standards related to medical devices is advantageous.</li>
<li>Familiarity with optical products, fluid dynamics and heat transfer are a plus.</li>
<li>Bachelor's degree in electrical, mechanical, biomedical, or systems engineering (Master's preferred).</li>
<li>Experience creating Design History Files (DHF) and technical file deliverables.</li>
<li>Project management experience with standard tools and practices.</li>
</ul>
Please Note: Qualified candidates must possess US Citizenship or US Greencard status to be considered upon submittal.
Company DescriptionThe experts at Connected Systems Partners, Inc. have decades of successful experience providing technology recruiting and staffing services for Fortune 500 companies to new business start-ups. We specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical and Engineering Technicians, in MA, NH, CT and RI. Since our founding in 2011, Connected Systems Partners has been providing a superior level of service to the technology workforce, looking to advance their careers and organizations looking to add contract, contract to hire, or permanent talent to their teams. Get Connected! 
<h3>Company Description</h3>
The experts at Connected Systems Partners, Inc. have decades of successful experience providing technology recruiting and staffing services for Fortune 500 companies to new business start-ups. \r\nWe specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical and Engineering Technicians, in MA, NH, CT and RI.\r\nSince our founding in 2011, Connected Systems Partners has been providing a superior level of service to the technology workforce, looking to advance their careers and organizations looking to add contract, contract to hire, or permanent talent to their teams. \r\nGet Connected!

Systems Engineer

<h3>Job Description</h3>
Job Description
PI (Physik Instrumente), LP is the world leader in high precision positioning systems: Nano Positioning, Micro Positioning, Precision Motion and Automation Systems. Our product lines include piezoelectric-based nano positioners, motorized stepper and servo stages, and linear motor stages. Our customers are the leading OEM’s and researchers in high tech fields such as semiconductor, photonics, biomedical, aerospace, astronomy, metrology, scientific instrumentation, and scientific research in microscopy and beam lines.
Our culture is open, transparent, enthusiastic with a general curiosity to solve emerging science and technology challenges. If you have an open, inquiring mind and like to develop solutions for first generation problems, you will be right at home. We are pioneers by nature; quite frequently, we are creating or building a device that will be applied for the first time, for a process that will be leverage for an entire marketplace.
We have a front-row-seat to innovation. Our customers are building the future generation of earth changing technologies. Our products help build products that everyone has or knows. We are a purposeful organization, and we collaborate to solve our customers' problems. Our engineering helps build success with our customers.
We have an immediate opening for an Application Engineer to support sales and our customers. The Application Engineer is a hands-on, customer-facing role based in our Applications Lab, at the PI US Headquarters in Auburn, MA. 
What You Will Do: 
<ul>
<li>Advocate for our best-in-class motion and positioning systems, throughout the entire sales process, through constant customer engagement.</li>
<li>Engineer and develop customer-focused solutions, working through the stages of mechanical assembly, software programming, and system controls processes.</li>
<li>Leverage your superior engagement skills to capture the voice of the customer to ensure the designed solution meets or exceeds the requirements.</li>
<li>Build and design solutions across the breadth of PI’s product offering, respond to customer requests, re-creating and testing issues from the field, ensuring customer system uptime.</li>
<li>Develop solutions for current and future market needs via Proof-of-Concepts.</li>
<li>Perform product demos at the customer facility, standard and new product installations, and custom retrofits.</li>
<li>Train customers on the proper use of PI products, tailored to suit their application</li>
<li>Leverage your deep product knowledge to assist customers in reaching higher levels of performance by delivering proactive support and creative troubleshooting.</li>
<li>Collaborate and coach internal and external stakeholders to ensure the sales cycle is complete and a strong technical solution has been delivered.</li>
<li>Build for the future, by documenting and communicating industry trends internally to drive next generation product development.</li>
<li>Provide customer support remote and on-site, as needed.</li>
</ul>
What Have You Done:
<ul>
<li>BS or Masters in Engineering, Mechatronics, Physics or another related field.</li>
<li>Experience using SolidWorks or other CAD programs.</li>
<li>The ideal candidate would have motion control experience and have worked with piezoceramics or DC/stepper/linear motors.</li>
<li>Experience in one or more of the following disciplines are a plus: hexapod/Stewart platforms; air bearing technology; microscopy; optics; photonics; laser processing; metrology and precision measurements; galvo scanners; or machine vision/imaging.</li>
<li>Experience working with 3D Printing, LabVIEW, MATLAB, Python, C, C#, C++, G-Code, is ideal.</li>
<li>Experience included Raspberry Pi or Arduino, Linux systems, industrial automation controls/PLC EtherCAT/TwinCAT and SPI communication interfaces is desired.</li>
<li>Ability to travel, less than 10% is anticipated.</li>
</ul>
What We Provide:
<ul>
<li>Blue Cross Blue Shield of MA PPO medical plan with HSA.</li>
<li>Dental and vision insurance.</li>
<li>LTD &amp; Life insurance.</li>
<li>401k with a generous company match.</li>
<li>Paid time off includes holiday, vacation and sick leave.</li>
</ul>
PI (Physik Instrumente), LP is an Equal Employment Opportunity Employer/Protected Veterans/Individuals with Disabilities. Employment is dependent on the results of an initial drug test and background check. We are open to reasonable accommodation – please contact us at <a href="mailto:HR@pi-usa.us" target="_blank">HR@pi-usa.us</a> for consideration.
We are not providing work authorization sponsorship for this opportunity.
Company DescriptionPI (Physik Instrumente), LP is the world leader in high precision positioning systems: Nano Positioning, Micro Positioning, Precision Motion and Automation Systems. Our product lines include piezoelectric-based nano positioners, motorized stepper and servo stages, and linear motor stages. Our customers are the leading OEM’s and researchers in high tech fields such as semiconductor, photonics, biomedical, aerospace, astronomy, metrology, scientific instrumentation, and scientific research in microscopy and beam lines. 
<h3>Company Description</h3>
PI (Physik Instrumente), LP is the world leader in high precision positioning systems: Nano Positioning, Micro Positioning, Precision Motion and Automation Systems. Our product lines include piezoelectric-based nano positioners, motorized stepper and servo stages, and linear motor stages. Our customers are the leading OEM’s and researchers in high tech fields such as semiconductor, photonics, biomedical, aerospace, astronomy, metrology, scientific instrumentation, and scientific research in microscopy and beam lines.

Application Engineer

<h3>Job Description</h3>
Job Description
JOB DESCRIPTION: 
Allied Technologies and Consulting (ATC) is recruiting for a Systems Engineer/Integration and Interoperability Engineer to assist our PM Soldier Medical Devices (SMD) government customer with supporting the modernization, advanced development, testing, fielding and deployment phases of the acquisition life cycle for devices, equipment, and systems used on the battlefield. This hybrid position, based in Frederick, MD, requires at least two days per week in the ATC office with three days as remote working from home.
DUTIES AND RESPONSIBILITIES: 
The experienced, professional, and dynamic Systems Engineer/Integration and Interoperability Engineer will assist with a variety of products and programs and perform the following duties:
<ul>
<li>
Work with Project/Product Managers, Logistics Managers, other Engineers, and End-Users to provide systems engineering support for multiple medical and non-medical products, programs, and systems.
</li>
<li>
Coordinate with a large network of matrixed organizations within the DoD, US Army, and other Federal agencies to ensure effective, efficient, and timely completion of the medical product development mission.
</li>
<li>
Participate in Integrated Product Teams (IPTs), working groups, and other meetings to apply engineering principles for the effective integration of technology into a system of systems using an incremental, phased approach.
</li>
<li>
Create actionable information based on requirements, technology maturity and availability for inclusion to programs of record in an incremental, phased approach.
</li>
<li>
Develop plans, schedules and estimates as they relate to systems integration.
</li>
<li>
Draft technical instructions, engineering plans, technical designs, and other systems integration related documents.
</li>
<li>
Manage configuration control, ensure successful integration and interoperability, and champion life-cycle management of products by building IPT partnerships with other DoD organizations.
</li>
<li>
Participate in the engineering requirements generation process with external Army organizations.
</li>
<li>
Conduct a systems analysis to include communications interface, data modeling, systems security, information assurance, patient privacy, and program assessment to support integration planning and systems program management.
</li>
<li>
Coordinate with required external program offices to establish required systems integration, communication and security between all key components and sub-components to effectively satisfy program requirements.
</li>
<li>
Develop systems engineering, program, and acquisition documentation in support of major acquisition decisions for assigned products and assemblages.
</li>
</ul>
<ul>
<li>
Develop and implement a system engineering management process to guide the development and management of a requirements-driven architecture through the entire system engineering life cycle for assigned products and assemblages.
</li>
<li>
Conduct internal project requirements analysis for assigned products and assemblages to derive lower-level requirements and system specifications with traceability from system specifications, through lower-level requirements, to the end user requirements.
</li>
<li>
Develop and implement the logistical strategic planning process for the provisioning of the subsystems that make up the end capability.
</li>
<li>
Develop and manage a test program that is consistent and aligns with the Test and Evaluation Master Plan (TEMP) for assigned products; compile test plans, processes, objectives, results, and other documentation.
</li>
</ul>
EDUCATION, SKILLS AND EXPERIENCE REQUIRED: 
<ul>
<li>
Bachelor’s degree in Systems Engineering, Systems Integration, Information Technology, or Biomedical Engineering or in a related technical field or combination of related experience and education.
</li>
<li>
At least 5 years of related experience and 10 years of working experience.
</li>
<li>
Knowledge of military/Army medical devices/systems; understanding of systems engineering concepts as well as life cycle management principles.
</li>
<li>
Excellent communications, writing, organizational and project management skills.
</li>
<li>
Sharepoint and MS Project experience desired.
</li>
<li>
Experience, knowledge and the ability to execute using Microsoft Office Suite, Word, PowerPoint, and Excel, as well as Microsoft Outlook.
</li>
<li>
Capability of applying software and/or systems engineering knowledge, skills and experience in integrating technology into a system of systems using an incremental approach.
</li>
<li>
Capability of applying knowledge, skills, and experience creating and manipulating systems engineering models using Systems Modeling Language (SysML).
</li>
<li>
Information Technology knowledge, skills and experience to include network architecture, network security, data flow, data management, and data security.
</li>
<li>
At least 2-3 years’ experience in Federal contracting, government or military environment is preferred.
</li>
<li>
Travel up to 25% of the time may be required
</li>
<li>
Public Trust T1-NACI Clearance Required
</li>
<li>
US Citizen
</li>
</ul>
<ul>
<li>
Must be able to pass background and drug testing.
</li>
<li>
THIS IS A FEDERAL CONTRACT.
</li>
</ul>
About Allied Technologies and Consulting 
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Equal Opportunity is the Law <a href="https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf" target="_blank">https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf</a>
Equal Opportunity is the Law Supplement <a href="https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf" target="_blank">https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplem…</a>
Pay Transparency Nondiscrimination Provision <a href="https://www.dol.gov/ofccp/pdf/pay-transp_unformattedESQA508c.pdf" target="_blank">https://www.dol.gov/ofccp/pdf/pay-transp_unformattedESQA508c.pdf</a>

Systems Engineer/Integration and Interoperability Engineer

<h3>Job Description</h3>
We have an open position for a Packaging Development Associate Principal Engineer (Design controls / Combination products) based in our Pharmaceutical Technology and Development (PT&amp;D) department. This role will support the entire PT&amp;D portfolio. PT&amp;D is the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
Make a positive impact, in a team where it means more. In Operations, we have a big ambition. to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.
What you will do:
We will rely on you to bring a strong packaging perspective to the department, delivering our packaging strategy in a diverse, multi-skilled area, and supporting our packaging activities on development projects from Phase 1 to the transfer to Commercial Manufacture. You will work with Development and Operations colleagues across the company.
<ul>
<li>
Lead the design &amp; development, and testing of all packaging presentations for medical devices and combination products to achieve project targets in a timely fashion.
</li>
<li>
Accountable for developing innovative, creative, and cost-competitive packaging solutions that meet the needs and requirements of our patients, our sustainability objectives, and our quality standards.
</li>
<li>
Generate and review regulatory submission documents, plans, protocols, and reports ensuring that the project objectives are met (Design History File documentation).
</li>
<li>
Contribute and support relevant information to the Design transfer team to enable successful packaging transfer to AZ manufacturing operations and/or contract manufacturing sites.
</li>
<li>
Ensure that work is performed in accordance with appropriate safety (SHE), quality, and compliance standards.
</li>
<li>
Influence understanding and interpretation of packaging regulations.
</li>
<li>
Represent specialist packaging area (SME) on Device Project Teams, ensuring the provision of appropriate data (technical, resource &amp; budgetary).
</li>
<li>
Understand and Influence developments within the industry.
</li>
<li>
Contribute to the training and development of packaging colleagues by acting as coach/mentor as appropriate.
</li>
</ul>
Minimum Qualifications:
<ul>
<li>
BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry.
</li>
<li>
Minimum 7 years experience
</li>
<li>
Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USA, Europe)
</li>
<li>
Strong technical and scientific skills with proven experience in the development of packaging solutions for parenteral and/or Inhalation products.
</li>
<li>
Strong experience with medical device or combination product commercialization, operations support, and significant packaging materials/components knowledge
</li>
<li>
Lean Six Sigma Green Belt or higher certification with strong problem-solving skills
</li>
<li>
Demonstrated ability to simultaneously handle multiple projects of variable complexity.
</li>
<li>
Strong operational relationships with customers
</li>
<li>
Experience of leading cross-disciplinary delivery teams
</li>
</ul>
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca:
Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability, and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by a supportive team, be part of accelerating our operational excellence with innovations in cutting-edge science, Lean ways of working, and fast-changing digital technologies.
Call to Action:
Ready to make a difference? Apply today!
LinkedIn <a href="https://www.linkedin.com/company/1603/" target="_blank">https://www.linkedin.com/company/1603/</a>
Facebook <a href="https://www.facebook.com/astrazenecacareers/" target="_blank">https://www.facebook.com/astrazenecacareers/</a>
Minimum
Date Posted
15-Jul-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Associate Principal Packaging Engineer

<h3>Job Description</h3>
Join our team as a Senior Process Engineer in Process Development, where you'll be responsible for supporting the development of a clinical manufacturing process of engineered T cells with patient-derived neo-antigen specific TCRs. Additionally, this role evaluates process and technology improvements, is critical to process understanding and process characterization, and is involved in manufacturing support and technology transfer to ensure successful implementation in a cGMP environment. This laboratory-based role works with the Senior Scientist, Process Development in Santa Monica, CA. If you're looking to work with curious minds in an inclusive culture, this is the place for you!
Accountabilities:
As a Senior Process Engineer, serving as a project manager with independent discretion you will design, implement, analyze, and document early and late-stage process development studies. You will collaborate within the team to interpret study results and contribute to technical discussions cross functionally for subsequent study design and decision making. You will also contribute to manufacturing support efforts; including batch record and SOP development, real-time troubleshooting, investigation and impact assessment of deviations, change control management, process monitoring and data analysis, and risk assessments.
Essential Skills/Experience:
<ul>
<li>BS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology, or related field with a minimum of -six (6) years OR MS degree with a minimum of four (4) years OR PhD with a minimum of one (1) year of relevant proven experience.</li>
<li>Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations.</li>
<li>Knowledge of QbD, DOE and statistical analysis tools (e.g., JMP, Minitab).</li>
<li>Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.</li>
<li>Strong verbal and written communication skills, including technical writing.</li>
<li>Experience in technical development of cell and gene therapy or biologics in early and late-stage development setting.</li>
<li>Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable.</li>
</ul>
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca's Oncology R&amp;D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Ready to join our team and make a difference? Apply now!
Date Posted
01-May-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Senior Process Engineer, Process Development

<h3>Job Description</h3>
Job Description
JOB SUMMARY
The Principal M365 Systems Engineer is responsible for the support of M365, which includes Active Directory, Azure AD, Exchange Online, and the M365 application suite. This individual is responsible for supporting, securing, maintaining, and managing the M365 collaboration tools, infrastructure, applications, and related technologies. Lastly, this role is responsible for administering the M365 platform with an emphasis on increasing enterprise collaboration and security. This position is based in the Fremont, CA office.
DUTIES &amp; RESPONSIBILITIES
<ul>
<li>Serve as Subject Matter Expert on capabilities of Microsoft 365 (M365) collaboration tools by providing a clear understanding of the changing technological landscape resulting in strengthened business processes and enhanced outcomes.</li>
<li>Manage and maintain the M365 environment, which includes overseeing Microsoft Exchange, SharePoint, Microsoft Teams, One Drive, Azure Active Directory, Conditional Access, and Intune.</li>
<li>Ensure M365 Suite aligns with the newest requirements of the CIS Security Framework (Conditional Access, Cloud Application Security).</li>
<li>Ensure the operational health of the M365 environment, including security, availability, performance, interoperability, and reliability.</li>
<li>Perform regular audits and control documentation around M365 access (Role-based Access Control).</li>
<li>Support an on-prem Windows server environment.</li>
<li>Provide 3rd-level support to the Help Desk and other IT teams for addressing issues related to messaging, collaboration, or identity systems. </li>
<li>Utilize InTune for the management and configuration of corporate laptops and other computing devices.</li>
<li>Manage SSO integrations with other SaaS platforms. Administer other SaaS platforms, specifically how they integrate with our M365 environment. </li>
<li>Provide backup support for VMWare virtual computing environment.</li>
</ul>
SUPERVISORY RESPONSIBILITIES
<ul>
<li>N/A</li>
</ul>
QUALIFICATIONS
 Required:
<ul>
<li>A Bachelor’s degree is required, preferably in Computer Science or a related field and 6+ years of related work experience . Six to eight years of work experience will be considered in lieu of a CS or related degree.</li>
<li>Minimum three years of experience with M365.</li>
<li>Demonstrated proficiency with Azure Active Directory, Exchange Online, InTune, Teams, OneDrive, and SharePoint.</li>
<li>Demonstrated knowledge of Microsoft Security and Compliance platforms, including DLP implementation. </li>
<li>Knowledge of PowerShell scripting with the ability to write scripts.</li>
<li>Experience with implementing and maintaining cloud management solutions including initial and ongoing configuration of related automation, notifications, and reporting capabilities.</li>
<li>Familiarity with web-based Identity Management concepts and methodologies including SAML, RADIUS, AD/LDAP, SSO.</li>
<li>Knowledge of Good Manufacturing Practice (GMP) and applicable Quality System Standards, ISO 13485 and ISO 14971.</li>
</ul>
Preferred:
<ul>
<li>Experience with AI technologies and enterprise rollout of Microsoft CoPilot.</li>
<li>Experience with supporting analytics platforms like Microsoft Fabric.</li>
<li>Experience maintaining production level application environments.</li>
<li>Experience maintaining SaaS platforms and toolkits.</li>
<li>Familiarity with healthcare and/or biomedical industries.</li>
</ul>
<ul>
<li>Microsoft certifications (e.g. Administrator Expert, Azure Administrator Associate).</li>
</ul>
COMPETENCIES
<ul>
<li>Drives results</li>
<li>Optimizes work processes</li>
<li>Decision Quality</li>
<li>Collaboration skills</li>
<li>Work with minimal supervision</li>
</ul>
PHYSICAL DEMANDS &amp; WORK ENVIRONMENT
<ul>
<li>Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.</li>
<li>Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.</li>
<li>Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.</li>
<li>Occasionally work around moving mechanical parts.</li>
<li>Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.</li>
<li>Must be able to travel as business necessitates (up to 10%).</li>
</ul>

Disclaimer:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

Principal M365 Systems Engineer

<h3>Job Description</h3>
Sr Manager, Cell Therapy Operations - Gaithersburg, MDAbout AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AZ, we’re proud to have an exceptional workplace culture that encourages innovation and collaboration. 
Here, employees are empowered to express diverse perspectives – and made to feel valued, energized and rewarded for their ideas and creativity. AZ is a place where passionate people can immerse themselves in their work and make significant contributions to scientific excellence and medicines – does this describe a place where you would like to work?We are seeking highly motivated Senior Scientists in Immuno-Oncology with scientific and technical expertise in innate and adaptive immune cell biology with a track record of scientific achievement to join our team in Gaithersburg, US. As a Senior Scientist you will be a key member of a team focused on supporting immune-oncology projects through the drug discovery process. 
You will bring your theoretical and practical expertise in immunology to establish assay systems and deliver datasets that will have direct impact on immune-oncology research projects.What you'll do:The Sr. Manager, Cell Therapy Operations is responsible for developing the processes and procedures to onboard/manage Apheresis Centers and Cell Therapy Centers, the day-to-day scheduling/logistics/communication with those centers for AstraZeneca Clinical CAR T-cell Therapies. This role will serve as the technical and operational single point of contact for Apheresis and Cell Therapy Centers.Responsibilities will include, but are not limited to the following:Establish apheresis/cell therapy site qualification criteria, documents/process and then conduct technical site assessments and training for AstraZeneca clinical trials.Create and maintain Apheresis and Product Administration manuals and forms that are product specific and consistent across all active trialsDevelop and foster relationships with apheresis/cell therapy site managers/staff for assigned region.Work with Clinical teams to establish the apheresis/cell therapy footprint to support the AstraZeneca clinical trials.Coordinate with internal teams and apheresis/cell therapy site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to support within the required timelines.Develop and build processes, SOPs, Wis, etc. 
to support the day-to-day operations of Clinical TrialsSupport the day-to-day operations (scheduling, communication, logistics, etc.) of Clinical TrialsProvide Quality Systems support by participating in deviation activities and impact/investigation assessments for apheresis/cell therapy centers.Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.Develop, maintain, and evaluate key performance indicators for patient treatment executionManage rollout of process changes to assigned sites.Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.Collect and enter data into electronic data management systems.Represent the department on cross-functional project teams, as requested.Comply with applicable SOP’s and regulations.Education, Qualifications, Skills and Experience:Essential Requirements:Ability to rapidly solve problems and deal with organizational complexityAbility to prioritize and complete work with sense of urgency based on criticalityMedical, scientific and clinical knowledgeKnowledge of applicable regulations and standards (ex-US knowledge a plus)High attention to detail skillsHigh organization skills with ability to multi-task several tasks in parallelRequired Undergraduate Degree in Life Sciences or Engineering (Registered Nurse, Biomedical Engineer)Experience in a regulated environment either hospital/clinic or pharmaceutical/biotechExperience in Cell Therapy Operations either hospital/clinic or pharmaceutical/biotechPreferred Requirements:Advanced degree in the Life Sciences or Engineering (e.g. Pharm D, NP, PA, Biomedical Engineer)Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programsPrior customer facing role in pharmaceutical/biotech industryExperience working with critical raw material suppliers or contract manufacturing organizationsWhy AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big! Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. 
Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? 
Come and join our journey.So, what’s next? A place built on courage, curiosity, and collaboration – we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take calculated risks that write the next chapter for our pipeline.If you are swift to action, confident to lead, willing to collaborate, and passionate about the possibilities, then we are keen to hear from you!Where can I find out more?Our Social Media, Follow AstraZeneca on LinkedIn <a href="https://www.linkedin.com/company/1603/Follow" target="_blank">https://www.linkedin.com/company/1603/Follow</a> AstraZeneca on Facebook <a href="https://www.facebook.com/astrazenecacareers/Follow" target="_blank">https://www.facebook.com/astrazenecacareers/Follow</a> AstraZeneca on Instagram <a href="https://www.instagram.com/astrazeneca_careers/?hl=enNext" target="_blank">https://www.instagram.com/astrazeneca_careers/?hl=enNext</a> steps:Apply today, or connect with our Talent Acquisition Partner – Kayla Harris: <a href="https://www.linkedin.com/in/kayla-harris-8723ab13b/" target="_blank">https://www.linkedin.com/in/kayla-harris-8723ab13b/</a> for a confidential discussion to explore this opportunity further. 
We are looking forward to hearing from you!Date Posted05-Sep-2023Closing Date06-Sep-2023AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. 
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Sr Manager, Cell Therapy Operations

<h3>Job Description</h3>
Job Description
Tight timeframe to submit REQUIRED: US CITIZEN OR PERM GC HOLDER-due to clearacne you will get per gov requirement Hybrid This position is primarily located at NIAID’s Rocky Mountain Laboratories campus in Hamilton, MT. You must reside within commuting distance to this client site and be able to be onsite as required to meet contractual obligations and project needs. In your role as a Senior HPC Architect, you will be a subject matter expert architecting, implementing, and managing multiple high performance compute clusters and their associated infrastructure for a large biomedical research community.. WHAT YOU’LL NEED TO SUCCEED: Education: BS/BA (or equivalent) Minimum of 10 years related experience Minimum of 5 years’ experience as engineer or architect with HPC technologies Hands-on architecture design experience with HPC to include storage, file system, InfiniBand, security, authentication, and compute architectures Experience with Slurm job scheduling, including troubleshooting job status and optimizing submission scripts Experience using Git to manage shared software configuration code bases Hands-on experience with cloud-based services (e.g. Azure, AWS, GCP) Minimum of five years’ experience in Linux systems administration Good understanding of storage administration and optimization, such as performing upgrades and defining RAID configurations Good understanding of fundamental networking concepts and their practical applications Experience with Spack or EasyBuild package manager, including making packages from PyPi, R, Github Knowledge and experience in one or more scripting languages applicable to Linux (e.g. Bash, Perl, Python) Preferred Skills: Experience administering RedHat / CentOS based systems Experience working in a life-sciences oriented environment Experience configuring and using monitoring systems to monitor HPC clusters Ability to determine meaningful metrics and usage data for monthly status reports and health dashboards Experience with DevOps or DevSecOps methodologies, such as automation and configuration management Strong troubleshooting skills #M2

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