Engineering Structures Login Jobs in Woburn, MA

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.

Georgia Tech prides itself on its technological resources, collaborations, high-quality student body, and its commitment to building an outstanding and diverse community of learning, discovery, and creation. We strongly encourage applicants whose values align with our institutional values, as outlined in our Strategic Plan. These values include academic excellence, diversity of thought and experience, inquiry and innovation, collaboration and community, and ethical behavior and stewardship. Georgia Tech has policies to promote a healthy work-life balance and is aware that attracting faculty may require meeting the needs of two careers.

About Georgia Tech
Georgia Tech is a top-ranked public research university situated in the heart of Atlanta, a diverse and vibrant city with numerous economic and cultural strengths. The Institute serves more than 45,000 students through top-ranked undergraduate, graduate, and executive programs in engineering, computing, science, business, design, and liberal arts. Georgia Tech's faculty attracted more than $1.4 billion in research awards this past year in fields ranging from biomedical technology to artificial intelligence, energy, sustainability, semiconductors, neuroscience, and national security. Georgia Tech ranks among the nation's top 20 universities for research and development spending and No. 1 among institutions without a medical school.

Georgia Tech's Mission and Values
Georgia Tech's mission is to develop leaders who advance technology and improve the human condition. The Institute has nine key values that are foundational to everything we do:
1. Students are our top priority.
2. We strive for excellence.
3. We thrive on diversity.
4. We celebrate collaboration.
5. We champion innovation.
6. We safeguard freedom of inquiry and expression.
7. We nurture the wellbeing of our community.
8. We act ethically.
9. We are responsible stewards.

Over the next decade, Georgia Tech will become an example of inclusive innovation, a leading technological research university of unmatched scale, relentlessly committed to serving the public good; breaking new ground in addressing the biggest local, national, and global challenges and opportunities of our time; making technology broadly accessible; and developing exceptional, principled leaders from all backgrounds ready to produce novel ideas and create solutions with real human impact.

Provide professional services in support of unit management in field as specified in the particular job posting. Focus will be in the professional field of Research Security. Specific duties will be determined based on assignment and unit needs. This position will interact on a consistent basis with: unit management and staff. This position typically will advise and counsel: unit management and staff. This position will supervise: NA

The Manager of Research Security is tasked with developing and implementing security protocols to protect sensitive research data and facilities from potential threats. This position requires a comprehensive understanding of security measures and compliance standards to ensure the safety of personnel and the integrity of research activities.

Job Duty 1 -
Perform duties related to professional field assignment.

Job Duty 2 -
Participate in reviews for compliance with policy and governmental regulations in the field.

Job Duty 3 -
Provide input to department policies and procedures.

Job Duty 4 -
May provide input to and administer project timelines and budgets.

Job Duty 5 -
May interact with vendors regarding procurement and delivery issues.

Job Duty 6 -
Perform other duties as assigned

Educational Requirements
Bachelor's Degree in related field or equivalent combination of education and experience

Required Experience
Up to two years of job related experience

• Have Top Secret Clearance
• Have SAP/SCI experience
• FSO/Security Specialist, Security Manager Experience, ITPS Experience

SKILLS
This job requires application of professional principles, processes and practices; application of regulations; utilization of basic and advanced computer applications including those specific to areas of responsibility; communication skills.

The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found on-line at policymanual/section8/C224/#p8.2.18_personnel_conduct.

Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found on-line at policymanual/section6/C2653.

The Georgia Institute of Technology (Georgia Tech) is an Equal Employment Opportunity Employer. The Institute is committed to maintaining a fair and respectful environment for all. To that end, and in accordance with federal and state law, Board of Regents policy, and Institute policy, Georgia Tech provides equal opportunity to all faculty, staff, students, and all other members of the Georgia Tech community, including applicants for admission and/or employment, contractors, volunteers, and participants in institutional programs, activities, or services. Georgia Tech complies with all applicable laws and regulations governing equal opportunity in the workplace and in educational activities.

Equal opportunity and decisions based on merit are fundamental values of the University System of Georgia (USG) and Georgia Tech. Georgia Tech prohibits discrimination, including discriminatory harassment, on the basis of an individuals race, ethnicity, ancestry, color, religion, sex (including pregnancy), national origin, age, disability, genetics, or veteran status in its programs, activities, employment, and admissions. Further, Georgia Tech prohibits citizenship status, immigration status, and national origin discrimination in hiring, firing, and recruitment, except where such restrictions are required in order to comply with law, regulation, executive order, or Attorney General directive, or where they are required by Federal, State, or local government contract.

This is not a supervisory position.
This position does not have any financial responsibilities.
This position will not be required to drive.
This role is considered a position of trust.
This position does not require a purchasing card (P-Card).
This position will not travel
This position requires security clearance.

Hello,

I hope you are dong well, Tech-Consulting is looking for Dynamic Entry Level Mobile Developer in Atlanta, GA. We are scouting talent in though US. Gel Along!

Job Title: Junior Mobile Developer

Experience: 0–2 years

Location: Atlanta, GA

Employment Type: Full-time

Job Overview

We are looking for a motivated Junior Mobile Developer to join our development team. You will assist in building, testing, and maintaining mobile applications for Android and/or iOS platforms. This role is ideal for someone who is passionate about mobile technologies and eager to learn from experienced developers.

Key Responsibilities

Assist in developing and maintaining mobile applications.

Write clean, efficient, and maintainable code.

Collaborate with UI/UX designers, backend developers, and product teams.

Debug and fix issues in existing applications.

Participate in code reviews and team meetings.

Test applications to ensure performance, quality, and responsiveness.

Stay updated with the latest mobile development trends and tools.

Required Skills

Basic knowledge of mobile development frameworks such as:

Flutter

React Native

Android Studio

Xcode

Programming knowledge in:

Dart

Java

Kotlin

Swift

JavaScript

Understanding of REST APIs and JSON.

Basic knowledge of Git version control (e.g., GitHub).

Familiarity with mobile UI/UX principles.

Good problem-solving and communication skills.

Qualifications

Bachelor's degree in Computer Science, Software Engineering, or related field (or equivalent experience).

Internship or project experience in mobile app development is a plus.

• Seniority Level
• Entry level
• Industry
• IT Services and IT Consulting
• Employment Type
• Full-time
• Job Functions
• Consulting
• Skills
• Mobile Technology
• Computer Science
• iOS
• Android Development
• Programming
• Java
• Mobile Applications
• JavaScript
• React Native
• Mobile Application Development
• Android
• Problem Solving

Sr. Project Manager

Location: Boston, MA (candidates must already reside in Massachusetts, preferably in the Boston area)

Schedule: 100% onsite at the main office or hospital project sites

Travel:

40–60% travel within approximately one hour of the main office to various hospital project sites. Mileage reimbursement provided.

Compensation

• $128K–$155K base salary
• Discretionary annual bonus
• $452/month vehicle allowance
• $80/month phone allowance

Overview

Large hospital construction project within the Boston metro area, consisting of multiple project sites.

Required Experience

• 8+ years of project management experience with a mechanical subcontractor
• Experience managing hospital construction projects valued at $5M+ (other commercial project types will not be considered)
• Strong experience managing subcontractors, vendors, budgets, and client relationships

Education

Bachelor's degree in Construction Management, Engineering, Architecture, or related field.

Equivalent HVAC or plumbing field experience may be considered.

Preferred Certifications

• PMP (Project Management Professional) – PMI
• Procore Certified
• OSHA 30, CPR, and First Aid (preferred)

Key Responsibilities

• Oversee all aspects of project delivery including financial management, subcontractors, vendors, and client relationships
• Maintain job site safety through safety planning, JHA approvals, toolbox talks, and site walks
• Manage project budgets and contract delivery types (GMP, Lump Sum, or Concession Agreement)
• Ensure contract compliance including insurance, reporting, scheduling, and energy savings requirements
• Oversee Procore project setup, including change management and document control
• Negotiate and execute vendor purchase orders and subcontracts
• Lead project handoff meetings and ensure alignment on project goals and client expectations
• Oversee site utilization planning with emphasis on safety, cleanliness, and access control
• Establish and manage the project baseline schedule and milestone tracking
• Lead monthly project reporting, cost reviews, and risk mitigation planning
• Ensure execution of the project quality assurance plan
• Manage change processes including RFIs, drawing revisions, and client directives
• Lead project meetings and distribute agendas and minutes
• Build and maintain relationships with subcontractors, vendors, and clients
• Manage and mentor Project Managers

Qualifications

• 8+ years of relevant experience
• Ability to manage multiple priorities and resolve project challenges effectively
• Proficiency with Microsoft Office and Procore

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match (100% of the first 3%, 50% of the next 2%)
• 120 hours PTO and 9 paid holidays
• Mileage reimbursement and monthly vehicle allowance.

*2nd shift, 3-11pm*

Job Summary

The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.

Responsibilities

• Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
• Lead and support four contract manufacturing associates; assign tasks and provide coaching.
• Ensure production suites, equipment, and materials are ready and compliant.
• Enforce cGMP, safety, and quality standards.
• Review batch records and documentation for accuracy and completeness.
• Execute shift schedules to meet production timelines.
• Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
• Support new processes, SOP implementation, and technology transfers.
• Provide clear shift handovers and communicate production status and risks.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
• 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
• Strong knowledge of cGMP regulations and documentation practices.
• Experience reviewing batch records and supporting deviation management.

Production Planning Supervisor

Direct Hire (Full-Time)

Onsite – Billerica, MA

We are looking for a skilled Production Planning Supervisor to support and optimize production operations for our expanding systems product lines at the Billerica, MA facility. This individual will be responsible for developing and executing the Master Production Schedule (MPS) to meet customer requirements while maintaining lean and efficient inventory levels. The role requires strong organizational ability, a proactive mindset, and the drive to excel in a fast-paced manufacturing environment.

The ideal candidate will bring expertise in lean manufacturing, MRP planning, inventory optimization, and Kanban systems, along with proven communication and leadership skills. Experience managing complex Bills of Materials (BOMs) and resolving cross-functional production challenges is important. This position reports directly to the Director of Manufacturing – Systems Products.

Key Responsibilities

• Partner daily with operations, purchasing, logistics, and shop floor teams to achieve production targets and schedule commitments.
• Lead and mentor a team of buyer-planners, ensuring operational efficiency and continuous improvement.
• Establish and communicate lead times and shipment schedules to the sales team based on material availability and production capacity.
• Analyze available capacity, highlight potential risks, and recommend mitigation strategies to management.
• Release and prioritize work orders based on MRP recommendations and Kanban triggers to support production schedules.
• Coordinate with engineering, quality, and manufacturing teams to align on internal and external customer requirements.
• Track actual performance against the Master Production Plan, identify variances, and implement corrective actions.
• Recommend and drive enhancements to planning processes, tools, and systems.
• Collaborate with warehouse teams to reconcile and resolve inventory variances.
• Support work order closure processes and resolve material transaction issues promptly.
• Participate in New Product Introduction (NPI) activities by planning build capacity and ensuring material readiness.
• Manage supplier quotations, PO awards, and related MRP or Kanban actions required to keep production on schedule.
• Perform additional tasks as needed to support overall operational goals.

Qualifications

• 5–10 years of planning experience in a manufacturing environment.
• Bachelor’s degree preferred; APICS certification is a plus.
• Strong proficiency in Microsoft Teams and the Microsoft Office suite, especially Excel.
• Familiarity with Oracle Cloud or Thruput is desired.
• Ability to thrive in a dynamic environment and balance multiple priorities effectively.

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.

Responsibilities 

• Support MAP manufacturing and process development for the Platform Research team.
• Work cross-functionally with formulation/analytical and preclinical teams to identify novel candidates for  development on the MAP platform, build platform flexibility and utility.  
• Develop and document batch records and test methods to characterize and support MAP formulation and  process development; identify opportunities for process improvement.  
• Thoroughly document MAP manufacturing process parameters, analyze data and trends, and effectively  communicate results through technical presentations and written reports.  
• Support early collaborations with strategic partners by generating proof-of-concept data packages.
• Interface with manufacturing and automation teams to share learnings and support platform improvement.
• Assist with the design and testing of new fixtures, tooling, and equipment to improve process throughput and  consistency.  

Qualifications 

• BS or MS in Biomedical, Chemical, or Mechanical Engineering, or related discipline with 0-2+ years of R&D  biotech or medical device experience.  
• Prior industry experience with novel platform and process development is preferred.  
• Familiarity with imaging and physical characterization techniques is a plus.  
• Experience with programming and prototyping/3D printing is a plus.  
• Experience with GxP is a plus.  
• Strong attention to detail. Ability to identify root causes of problems and recommend corrective actions.
• Excellent verbal and written communication skills. 
• Demonstrated abilities to learn new skills and fields, solve challenging technical problems, think independently,  and work collaboratively in cross-functional teams 
• Entrepreneurial spirit and drive to positively impact public 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: 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   

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

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

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

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