Information Technology For Development Jobs in Bedford, MA
465 positions found — Page 5
Principal Program Manager
L3Harris Space Systems is seeking a Program Manager for the Agile Electro-Optics (AEO) Business Area. This role will be responsible for overall program management of Government contracts and is accountable for program execution, customer satisfaction, and financial performance. The Program Manager will lead a development program to design, develop, build, and demonstrate a next generation electro-optical space payload. Our AEO Business Area provides an exciting, dynamic, and flexible work environment. When you join our team, you will be supporting missions of national significance including Space Domain Awareness, Missile Warning and Defense, Science, and Weather as well as Remote Sensing for commercial and Government customers.
Management of large, complex programs involving advanced electro-optical technology for space applications that are of significant strategic importance to the business area and nation
• Accountable for the cost, schedule, and technical performance of the program through all phases, inception to completion
• Lead the program to meet quarterly and annual financial commitments to the Business Area
• Establish and nurture high-level customer relationships, and influence senior leadership to adopt and champion the business area concepts and strategy
• Effectively communicate within the team, upward with internal executive leadership, and externally with the customer to influence stakeholders for business success
• Work within a highly dynamic and changing environment and adapt to shifting customer priorities
Bachelor’s Degree and a minimum of 12 years of prior relevant experience; Or, Graduate Degree and a minimum of 10 years of prior related experience; Ability to obtain a Top Secret security clearance, with preference for a current active Top Secret security clearance
Experience managing projects for space optical applications
• Knowledge of Government contracting practices and Earned Value Management (EVMS)
• Project Manager Professional (PMP) certification
• Experience planning, organizing, and directing work that provides best value solutions to the customer and L3Harris
• Experience using Microsoft Project, and the Microsoft Office suite of applications
• L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The application window for this requisition is anticipated to close May 20, 2026.
#All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.
Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.
Job Title: Lead, Integration & Test Engineering (Space Optical Systems)
Relocation: Relocation assistance is available to qualified applicants
We don't work here just for the advanced technology and equipment: we work here because we know what - and who - we're protecting! From families to the intelligence community, and from our climate to our men and women in uniform - we're making the world a safer place!
L3Harris Space Superiority group has an opening for a Integration & Test Engineer to join our team of qualified, diverse individuals. The successful candidate will support the program technical leads (Lead or Chief Systems Engineer, IPT Lead) by performing technical analysis, managing specifications, and generating design review and technical documents. Additional responsibilities include supporting the test and design verification, requirements sell off, end item data package (EIDP) generation efforts.
Develop and integrate advanced electro-optical systems for space-based applications, ensuring compliance with all relevant specifications and mission requirements.
Team Leadership: Lead a team of engineers, overseeing and ensuring technical execution of projects. Mission Payload AI&T Management: Manage major subcontract cost, schedule, and performance and oversee the overall Mission Payload Flight AI&T (Assembly, Integration, and Test) activities.
Testing and Validation: Design, plan, and execute test procedures for electro-optical components and systems. Analyze test data to validate system performance against requirements. Requirements Management: Define, manage, and maintain system and sub-system level requirements, ensuring traceability and compliance throughout the project lifecycle.
Project Execution: Lead and coordinate multidisciplinary engineering teams throughout the project lifecycle, from conceptual design to final system delivery and operation.
Stakeholder Communication: Communicate effectively with internal and external stakeholders, including subcontractors and U.Government customers, to ensure alignment and project success.
Standards Compliance: Ensure all engineering activities adhere to industry standards, regulatory requirements, and best practices.
Collaboration: Work closely with cross-functional teams, including engineering, production, and quality assurance, to ensure successful system integration and test.
Prepare effective presentations to communicate technical information to non-technical professionals.
Continuous Improvement: Participate in process improvement initiatives to enhance test methodologies and system integration practices.
Training and Mentoring: Provide training and mentorship to junior engineers, fostering their development and growth within the team.
Candidate must be eligible to obtain a DoD security clearance.
Bachelor's degree in Engineering, Physics, or other related scientific discipline and 9 years of relevant EO/IR systems engineering work experience. Alternatively, a graduate degree with a minimum of 7 years of prior related experience, or in lieu of a degree, a minimum of 13 years of prior related experience.
~Prior or current experience working with space environment considerations and testing protocols
~ Experience as a Control Account Manager (CAM) and Integrated Product Team Lead (IPTL) is required
~5+ years experience with engineering and simulation software tools, such as MATLAB
Active Secret or Top Secret/SCI clearance is highly preferred
Demonstrated experience with space systems engineering, including knowledge of space environments, satellite systems, and space mission design. Experience in leading technical teams, managing projects and competing priorities, and coordinating cross-functional engineering activities.
Proficient in Model-Based Systems Engineering (MBSE) and traditional systems engineering tools such as DOORs, CAMEO, CREO, JIRA, and SysML.
Strong analytical and problem-solving abilities, with a proven track record of tackling complex engineering challenges.
Ability to work effectively in a team environment and collaborate with multidisciplinary teams to achieve project goals.
In compliance with pay transparency requirements, the salary range for this role in Massachusetts is $1119,500 - $222,500. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law.
Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.
Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.
This role is responsible for managing Government contracts, program execution, customer satisfaction, and financial performance.
The Program Manager will lead a program to design, develop, build, and demonstrate next-generation electro-optical space payloads.
Join our dynamic team to support missions of national significance, including Space Domain Awareness, Missile Warning and Defense, Science and Weather, and Remote Sensing for commercial and Government customers.
Essential Functions: • Management of large, complex programs involving advanced electro-optical technology for space applications that are of significant strategic importance to the business area and nation • Accountable for the cost, schedule and technical performance of the program through all phases, inception to completion • Lead the program to meet quarterly and annual financial commitments to the business area • Drive program execution, proactively identify and support capture management efforts of additional scope to grow the program and support technology investment plans • Establish and nurture high-level customer relationships, and influence senior leadership to adopt and champion the business area concepts and strategy • Effectively communicate within the team, upward with internal executive leadership, and externally with the customer to influence stakeholders for business success • Champion and leverage new technology to establish differentiators that produce impact on business area results • Contribute to and promote a positive culture and working environment • Work collaboratively with the functional organizations to ensure that all resources are available and empowered to meet program goals • Work within a highly dynamic and changing environment and adapt to shifting customer priorities Qualifications: • Bachelor’s Degree and a minimum of 9 years of prior relevant experience; Or, Graduate Degree and a minimum of 7 years of prior related experience; Or, in lieu of a degree, a minimum of 13 years of prior related experience • Ability to obtain US Government security clearance Preferred Additional Skills: • Active Top Secret Security Clearance is preferred • Experience managing projects for space optical applications • Solid technical background with strong business acumen • Experience implementing strategies to influence external stakeholders for business advantage • Knowledge of Government contracting practices and Earned Value Management (EVMS) • Excellent interpersonal, written, and verbal skills • Project Manager Professional (PMP) certification • Proposal management experience • Experience planning, organizing, and directing work that provides best value solutions to the customer and L3Harris • Experience using Microsoft Project, and the Microsoft Office suite of applications • Ability to develop broad, cooperative relationships with numerous groups and individuals, even when having no direct authority over them In compliance with pay transparency requirements, the salary range for this role in Massachusetts state is $125,000-$232,000.
L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays.
The application window for this requisition is anticipated to close April 26, 2026.
All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws.
Please be aware many of our positions require the ability to obtain a security clearance.
Security clearances may only be granted to U.S.
citizens.
By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.
Please click here for the E-Verify Poster in English or Spanish .
For information regarding your Right To Work, please click here for English or Spanish .
Salary Range: 167k - 211k
Title: Senior Manufacturing Engineering Manager
Company Description
Vaxess is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Manufacturing Engineering Manager is responsible for building and leading a high-performing Manufacturing Engineering organization supporting Phase 2 and Phase 3 clinical manufacturing of a highly automated pharmaceutical–medical device combination product manufactured in ISO Class 5 isolator environments and will report to the VP of Manufacturing.
This role provides technical leadership for process development transfer, equipment integration, MES/electronic batch record implementation, validation execution (IQ/OQ/PQ), and establishment of scalable GMP manufacturing systems. The position requires strong problem-solving capability, hands-on leadership, and the ability to operate effectively within a fast-paced startup environment transitioning to late-stage clinical readiness.
Responsibilities
- Build, lead, and develop a team of manufacturing engineers and engineering technicians. Recruit, mentor, and performance-manage engineering staff and manufacturing technicians.
- Develop training frameworks for GMP technicians and operators supporting highly automated production lines.
- Lead transfer and integration activities of highly automated manufacturing systems, including custom automation and OEM equipment.
- Develop and execute Master Validation Plans (MVPs) covering facilities, utilities, process equipment, and ancillary systems for operation in Grade A/ISO Class 5 isolator-based manufacturing environments.
- Lead generation, review, and approval of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols
- Collaborate cross-functionally to ensure traceability between URS, design specifications, FAT/SAT, and qualification protocols.
- Oversee implementation and lifecycle management of, Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), Equipment data acquisition systems, Integrated automation platforms
- Develop SOPs, work instructions, maintenance procedures, and engineering documentation to support validated operations.
- Lead structured root cause investigations (e.g., deviation investigations, CAPAs, equipment failures, yield excursions).
- Apply engineering rigor and statistical methods to improve process capability and equipment performance.
- Scale processes from early clinical manufacturing through Phase 3 readiness, ensuring process robustness and repeatability by the implementation of KPIs for, OEE, Throughput, Yield, Deviation rate, Batch release cycle time, Validation execution timelines
- Partner with Quality, Regulatory, and Supply Chain to ensure phase-appropriate compliance and scalability.
- Foster a culture of accountability, urgency, technical rigor, and continuous improvement driving operational readiness for increasing clinical demand.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related discipline (Master’s preferred).
- 8–12+ years of experience in pharmaceutical, biotech, or medical device manufacturing.
- Minimum 3–5 years of people management experience leading engineers and/or technicians.
- Direct experience supporting Phase 2 and/or Phase 3 clinical manufacturing environments with combination products, polymer processing and / or unique drug releasing processes/products.
- Demonstrated experience with: Master Validation Plan development, IQ/OQ/PQ execution, Process validation, GMP documentation systems and MES and electronic batch record implementation.
- Experience with highly automated manufacturing lines and equipment integration.
- Experience operating within Grade A/ISO Class 5 or aseptic/low bioburden environments.
- Demonstrated success in startup or rapidly scaling manufacturing environments.
Preferred Qualifications
- Experience with drug–device combination products.
- Experience in isolator-based manufacturing systems.
- Knowledge of 21 CFR Parts 210/211, 820, and Part 11 requirements.
- Strong understanding of validation lifecycle management and risk-based qualification strategies.
- Experience implementing KPI-driven manufacturing organizations.
- Lean/Six Sigma certification or equivalent process improvement background.
Core Competencies
- Strategic yet hands-on technical leadership
- Strong project management and cross-functional coordination
- Structured problem solving and risk assessment
- Ability to balance speed and compliance in a startup setting
- High energy, adaptability, and resilience
- Clear communicator with executive-level reporting capability
Salary Range: 65k-95k
Title: Materials Management Specialist/Senior Materials Management Specialist
Location: Woburn, MA (on-site 5 days per week)
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Role:
Works under the operations team and in coordination with the Quality Assurance (QA) team to oversee the entire flow of materials, from procurement and inventory control to receipt to storage and distribution. Ensure all materials meet defined specifications and are available for intended use and quantities to support user needs. Provide continuous improvement efforts in purchasing, planning, and warehousing. Key responsibilities include strategic sourcing, inventory optimization, demand forecasting, supplier negotiation, and managing logistics for clinical distribution while reducing waste and costs.
Responsibilities:
- Develop material strategies, forecasts demand, plans production and inspection schedules, and aligns material flow with business goals.
- Maintains optimal inventory levels, conducts physical counts, investigates discrepancies, and implements lean manufacturing principles.
- Supervises purchasing, inventory, and warehouse activities in a manner consistent with cGMPs.
- Assists Quality Assurance to assign and document the status for all materials used in the development of Vaxess products.
- Implements initiatives to reduce waste, cost efficiencies, and improve financial performance.
- Sources, negotiates, and purchases goods and services, building strong supplier relationships and ensuring quality and reliability.
Qualifications:
- 2 to 5 years in Material Management or Shipping and Receiving in the Pharmaceutical or Medical Device Industries working in a cGMP Environment.
- Strong understanding of supply chain, logistics, and inventory principles.
- Experience with ERP Systems/SAP preferred.
- Experience with standard cGMP storage requirements for Quarantine, Release and Rejected materials.
- Experience with the receipt, storage, distribution, and shipping of temperature-controlled materials.
- Bachelor’s Degree in a relevant field (Logistics, Biomedical Engineering or Health Care Management and certifications (APICS, ISM) preferred.
At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to
Salary Range: 72-114k
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Electrical Control Engineer designs, develops, programs, and maintains automated control systems used in industrial, manufacturing, or infrastructure environments. The role focuses on improving system efficiency, reliability, and safety through PLCs, machine vision, HMIs, robotics, and industrial networks.
Responsibilities:
- This is a hands-on position involving designing, building, and troubleshooting automated equipment.
- Design and maintain novel automated systems and solutions that contribute to current manufacturing and scale up of manufacturing operations to eventual commercialization.
- Project management of electrical and controls projects.
- Design control schemes, circuits, power distribution, high/low voltage, electrical panels, and layouts.
- Document electrical schematics and BOMs and contribute to assembly and installation of systems.
- Develop and optimize machine vision inspection equipment, lighting, optics, and code.
- Troubleshoot electrical and control issues to contribute to root cause analysis and develop timely solutions for production problems that might arise.
- Contribute to continuous improvement to increase safety, quality, and efficiency of manufacturing.
- Draft maintenance SOPs and contribute to implementation and maintenance of the Quality System.
- Draft equipment requirements and work closely with external vendors to develop plans and evaluate proposals, and manage external projects.
- Collaborate closely with cross-functional teams to support product development and manufacturing activities.
Qualifications:
- BS or MS in Electrical Engineering or a related discipline.
- 3-5 years of high volume medical device or pharmaceuticals manufacturing or related experience.
- CAD (SolidWorks or similar) for electrical schematics and drawings
- Familiarity or experience working with machine vision (OpenCV, Cognex Pro, or similar), motion control and PLC & HMI platforms (Rockwell/Allen-Bradley or similar), general programming (Studio 5000, Python, C++, or similar)
- Excellent time and project management skills and proven ability to meet goals and deadlines.
- Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.
- Entrepreneurial spirit and drive to positively impact global human health.
At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value
collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to
Salary range: 107-135k
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Role:
As a Senior Process Engineer at Vaxess, you will join a team focused on developing innovative manufacturing processes for production of high-quality therapeutic micro-array patches. Your contributions will support advancement of pipeline programs through clinical development, as well as establishment of a platform to enable high-throughput commercial scale manufacturing.
Responsibilities:
- Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams
- Support manufacturing scale-up by assessing novel equipment, workflows, analytical techniques/PAT, and process configurations
- Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess’ Quality System.
- Supervise and mentor junior engineer(s) and technicians, including a direct report
- Collaborate closely with cross-functional teams to support product development and manufacturing activities
Qualifications:
- BS or higher in Engineering (Mechanical, Biomedical, Manufacturing, Materials, or related)
- 7 – 9 years of relevant, hands-on R&D experience within the medical device or biopharmaceutical industries; experience working on combination products in a GMP environment is highly desirable
- Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus
- Excellent time and project management skills and proven ability to meet goals and deadlines
- Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams
- Entrepreneurial spirit and drive to positively impact global human health
At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to
Location: Woburn, MA (on-site 5 days per week)
Hours: 8am - 5pm
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
Responsibilities
- Perform cGMP manufacturing operations according to documented procedures or batch records
- Operate automated manufacturing equipment and record relevant in-process data.
- Complete production and testing records following Good Documentation Practices (GDP)
- Handle, assemble, and visually inspect products, including use of a microscope, automated inspection systems, or other optical systems.
- Contribute to root cause analysis (RCA) and help contribute to manufacturing investigations
- Support manufacturing related R&D efforts as needed
- Perform other assigned duties related to manufacturing, quality control, and/or facility operations.
Qualifications
- 2 + years’ relevant experience working in regulated environments in medical device or biopharmaceutical industries; experience working in a clean room is preferred
- High school diploma minimal, associate’s degree or trade certifications preferred
- Good written and verbal communication skills, attention to detail, and a demonstrated ability to work effectively within a team
- Ability to stand or sit for a full shift on a manufacturing line
- Entrepreneurial spirit and drive to positively impact global human health
At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to
Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job Diva ID: 26-08545
Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
- Lead and conduct viral/non-viral vector purification process development and process analytics
- Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
- Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
- Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
- Perform troubleshooting experiments and communicate findings with appropriate working groups
- Maintain industry knowledge and keep abreast of new and relevant technologies
- Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
- Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
- Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
- Mentor and support junior staff and build a culture of support and collaboration
Key Requirements and Technology Experience:
- Key skills: - Purification experience/ Protein Purification Chromatography
- Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
- PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
- Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
- Significant experience, knowledge and understanding of purification technologies and operations such as:
- Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
- Protein purification chromatography
- Virus clearance and inactivation
- Familiarity with advanced purification technologies and process analytical technologies
- Familiarity with analytical method transfer, analytical method bridging across organizations
- Experience with process technology transfers and performing gap analyses and risk assessments
- Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
- Expertise in technical report writing
- Experience in AAV and/or non-viral purification development
- Experience in writing CMC components of regulatory dossiers
- Knowledge of product comparability, target product profile and quality risk assessment activities
- Viral clearance study design and execution
- Late-stage purification experience such as design space mapping and process robustness studies
- Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
- Ability to work under minimal supervision and function within a collaborative, team-oriented environment
- Excellent organization and communication skills
- Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
- Experience with biophysical characterization
- Experience in continuous manufacturing and process analytical technology
- Experience in mentoring junior staff
- Ability to build and nurture cross-functional relationships
- Ability to communicate and represent group in diverse, multi-functional meetings
Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Paragonix Technologies is a rapidly growing medical device manufacturer which designs, manufactures, and commercializes organ preservation technologies. Our dynamic team is committed to improving the lives of organ transplant recipients by providing advanced technologies to ensure optimal preservation for donor organs on the journey to their ultimate recipients. Our technologies provide preservation and a digital ecosystem for heart, lung, liver, kidney, and pancreas organs. A strong desire for advancing medicine, intellectual curiosity for the field of organ transplantation, and desire to respect the selfless wish of the donor to save the lives of multiple recipients are factors that drive the team every single day.
ABOUT THE ROLE
The Globalization Product Manager will be responsible for supporting the global roll out and localization of our product positioning. This role will have visible interactions in a highly matrixed organization to sales and clinical teams around the world. The role will be responsible for understand unique market conditions and determining optimal market entry strategies.
The successful candidate thrives in a fast-paced environment in which constant ambiguity is viewed as an opportunity for both advancing the field of transplantation and growing professionally. The initial focus of the role with be on the physical organ preservation platforms and may evolve over time.
POSITION RESPONSIBLITIES
- Continuously partner with commercial sales and clinical support team to identify new tactical and strategic opportunities to drive growth
- Customize messaging and promotion strategies to the unique geographic, legal, ethical, regulatory and policy environment to ensure market success.
- Work closely with US Transplant Care Division Marketing team on marketing campaigns, communications, collateral and event coordination
- Identify and address regulatory challenges and opportunities in transplant legal & regulatory frameworks and policy changes country by country.
- Drive initiatives to support local reimbursement collaborating with local partners.
- Stay current on the latest changes in clinical data and train sales teams on the latest tools to support local positioning.
- Lead knowledge-sharing sessions following attendance at clinical conferences, webinars, and educational events to drive organizational learning and proactively shape commercial strategy and next-generation product development, ensuring insights from emerging industry trends directly inform business initiatives.
- Monitor competitive activity through review of clinical, financial, regulatory, and intellectual property filings
- Conduct primary and secondary market research to inform direction on existing programs and future strategies.
- Collaborate with regulatory for global expansion priorities
- Collaborate with cross functional leadership and team members to ensure effective market launch and continuous improvement throughout product lifecycles
POSITION REQUIREMENTS
- At least 3 years of professional experience in product management
- Bachelor's degree in life sciences technical field (biomedical engineering, biology, biochemistry, public health, etc.)
- Fundamental understanding of biology or human anatomy
- Comfortable engaging and interacting with experts from diverse skillsets and cultural backgrounds
- Excellent interpersonal relationships, with the ability to adapt communication style based on context and individual
- High level of comfort with developing, interpreting, and communicating complex technical information with impactful visualizations and supporting data.
- Demonstrated ability and/or interest in working in a fast-paced, matrixed organization that requires quick response to changing market demands.
- Intellectually curious for both technical and non-technical subjects
- Strong oral communication, presentation, project management and prioritization skills
PHYSICAL REQUIREMENTS
- Travel: 30-50%, may expand with role
- Language: Must be professionally fluent in English
Annual Salary of 150K-170K depending on experience with 20% STIP
#LI-JF1 #LI-Hybrid
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
