Information Technology For Development Jobs in Upper Arlington

About Us

One Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isn’t your average doctor’s office. We’re on a mission to transform healthcare, which means improving the experience for everyone involved - from patients and providers to employers and health networks. Our seamless in-office and 24/7 virtual care services, on-site labs, and programs for preventive care, chronic care management, common illnesses and mental health concerns have been delighting people for the past fifteen years.

In February 2023 we marked a milestone when One Medical joined Amazon. Together, we look to deliver exceptional health care to more consumers, employers, care team members, and health networks to achieve better health outcomes. As we continue to grow and seek to impact more lives, we’re building a diverse, driven and empathetic team, while working hard to cultivate an environment where everyone can thrive.

Employment type:

• 
  
• Full time 
  

What you'll be working on:

• 
  
• Managing a patient panel with a broad array of patient needs; conducting a mix of acute, chronic, and well visits
  
• Treating patients in-office or in testing centers as well as conducting occasional tele-health visits
  
• Continuous learning during weekly Clinical Rounds and through other modalities
  
• Ongoing collaboration with in-office teammates via daily huddles, as well as with virtual clinical teams 
  
• Utilization of your specific clinical training and opportunities to perform in-office procedures 
  
• Supervising one or more NP or PA colleagues
  
• Willing to obtain additional state licensure and credentialing for One Medical virtual primary care in additional states
  

Education, licenses, and experiences required for this role:

• 
  
• Enrolled in, or have completed, an accredited Internal or Family Medicine residency program
  
• Practiced at least 2 of the last 5 years in an outpatient primary care setting
  
• Board Certified in Internal or Family Medicine, or Board Eligible with plans to obtain board certification within 1 year of your One Medical start date 
  
• State licensed in Massachusetts, obtained before your One Medical start date
  

One Medical providers also demonstrate:

• 
  
• A passion for human-centered primary care 
  
• The ability to successfully communicate with and provide care to individuals of all backgrounds   
  
• The ability to effectively use technology to deliver high quality care
  
• Clinical proficiency in evidence-based primary care
  
• The desire to be an integral part of a team dedicated to changing healthcare delivery
  
• An openness to feedback and reflection to gain productive insight into strengths and weaknesses
  
• The ability to confidently navigate uncertain situations with both patients and colleagues
  
• Readiness to adapt personal and interpersonal behavior to meet the needs of our patients
  

This is a full-time role based in Boston, Massachusetts. 

One Medical is committed to fair and equitable compensation practices. The base salary range for this role is $252,000 to $267,800 per year. Total compensation packages may be based on factors unique to particular candidates, such skill sets, depth of experience, and work location. The total compensation package for this position may also include restricted stock unit grants, and/or benefits. For more information, visit   

One Medical offers a robust benefits package designed to aid your health and wellness.  All regular team members working 24+ hours per week and their dependents are eligible for benefits starting on the team member's date of hire:

Taking care of you today

• 
  
• Paid sabbatical for every five years of service
  
• Free One Medical memberships for yourself, your friends and family
  
• Employee Assistance Program - Free confidential services for team members who need help with stress, anxiety, financial planning, and legal issues
  
• Competitive Medical, Dental and Vision plans
  
• Pre-Tax commuter benefits
  
• PTO cash outs - Option to cash out up to 40 accrued hours per year
  

Protecting your future for you and your family

• 
  
• 401K match
  
• Credit towards emergency childcare
  
• Company paid maternity and paternity leave
  
• Paid Life Insurance - One Medical pays 100% of the cost of Basic Life Insurance
  
• Disability insurance - One Medical pays 100% of the cost of Short Term and Long Term Disability Insurance
  

In addition to the comprehensive benefits package outlined above, practicing clinicians also receive

• 
  
• Malpractice Insurance - Malpractice fees to insure your practice at One Medical is covered 100%.
  
• UpToDate Subscription - An evidence-based clinical research tool
  
• Continuing Medical Education (CME) - Receive an annual stipend for continuing medical education
  
• Rounds - Providers end patient care one hour early each week to participate in this shared learning experience
  
• Discounted rate to attend One Medical’s Annual REAL primary care conference
  

One Medical is an equal opportunity employer, and we encourage qualified applicants of every background, ability, and life experience to contact us about appropriate employment opportunities.

One Medical participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.  Please refer to the E-Verification Poster and Right to Work Poster for additional information.

** Please note that this is an on-site position without remote capability. This position requires travel between multiple sites. **

About IT at Cambridge Health Alliance (CHA)

The Information Technology Department at Cambridge Health Alliance empowers high-quality, equitable, and patient-centered care through innovative and secure health IT solutions. Grounded in CHA’s mission and strategic plan, IT supports clinical, operational, and academic excellence by providing reliable infrastructure, safeguarding health information, and enabling data-driven decision-making. With a future-focused approach, the team works to enhance access, advance health equity, and drive innovation across the system.

Position Overview

Reporting to the Director, Network & Telecommunications, the Senior Network Engineer serves as the principal technical authority for the Cambridge Health Alliance enterprise voice and data network. This role entails the coordination of all network implementations, modifications, and maintenance, ensuring stringent alignment with the overall enterprise design. The incumbent will function as a senior engineer to LAN, WAN, and Cableplant engineers and technicians, thereby fostering high-quality, patient-centered care through the deployment of secure and innovative health IT solutions.

Key Responsibilities

• Conduct research and furnish recommendations for strategically appropriate support tools and systems, including network management platforms, traffic analysis solutions, and retrospective/prospective projection modeling.
• Lead the configuration, installation, implementation, and advanced troubleshooting of micro-segmentation, routers, switches, wireless controllers and infrastructure, and other critical communication devices.
• Systematically monitor response times, bandwidth utilization, and resource availability to propose and implement performance enhancements. Utilize specialized surveying tools to optimize coverage and capacity within high-density environments.
• Design and administer the IP address scheme and associated IP address assignment mechanisms.
• Design, deploy, and maintain robust enterprise wireless networks, including the execution of site surveys and comprehensive RF planning.
• Configure and troubleshoot wireless access points (APs) and wireless LAN controllers (WLCs).
• Ensure the integrity and security of the wireless network through the implementation of WPA2/3 protocols, and RADIUS integration. Proven hands-on experience implementing Network Access Control (NAC) solutions.
• Resolve complex and atypical network problems, employing advanced packet capture and protocol analysis tools such as Wireshark.
• Monitor and coordinate the maintenance of network hardware and software to ensure maximum operational efficiency and uptime.
• Maintain up-to-date, meticulously detailed network topological diagrams and documentation for the entire CHA network and all business partner connections.

Technical Requirements & Qualifications

Education, and Experience

• Bachelor’s Degree in Computer Science, Engineering, or a closely related field is required; equivalent significant professional experience (e.g., a minimum of 6 years total experience) may be substituted.
• A minimum of 7-10 years of progressive experience in network engineering within an enterprise environment is mandatory, with at least 5 years served in a Senior Network Engineering role.
• Experience within a large, distributed, and complex healthcare organization is highly desirable.

Technical Knowledge

• Demonstrated hands-on experience with Juniper, Aruba.
• Advanced and comprehensive knowledge of OSPF, EIGRP, BGP, RIP, RIPv2, TCP/IP, UDP, ICMP, EVPN-VXLAN and 802.1x standards.
• Deep understanding and practical application of VLANs, data/voice trunking, Spanning Tree Protocol (STP), Link Aggregation Group (LAG), and layer 2/3 fault tolerance design.
• Proficiency in the configuration and management of Access Control Lists (ACLs), Firewalls, Virtual Private Networks (VPNs), and Network Access Control (NAC) solutions and wireless security.

Certifications (Desired)

• Juniper Networks Certified Professional - Service Provider (JNCIP-SP) or Juniper Networks Certified Professional - Enterprise (JNCIP-ENT)
• Aruba Certified Mobility Professional (ACMP)
• CompTIA Network+ or Security+
• Certified Wireless Network Professional (CWNP) certifications (CWNA, CWAP, CWDP)

Working Conditions and Physical Demands

• Mandatory rotating 24/7 on-call support is required, necessitating a 30-minute remote response time or a 1-hour on-site response time.
• Must possess reliable personal transportation to facilitate travel between multiple sites.

Please note that the final offer may vary within the listed Pay Range, based on a candidate's experience, skills, qualifications, and internal equity considerations.

Location: CHA Somerville Campus

Work Days: Monday - Friday, 8:30am - 5:00pm, On-call Rotation

Department: IT CHA Network

Job Type: Full time

Work Shift: Day

Hours/Week: 40

Union Name: Non-Union

Role: Administrative Support Staff

Location: onsite daily - Boston, Massachusetts

Duration: 8 month contract (through end of November) extension possible

Work Schedule: 35 hours/week ? TBD 8:30-4:30 or 9:00-5:00

Job Description:

Administrative Support Staff

Position Overview

Provide administrative support for the Women Who Empower Innovator Awards application cycle, ensuring smooth operations from call for applications through finalist selection. This role supports the Special Assistant and Project Manager of Alumni Relations and Annual Giving and works in partnership with the Executive Director of Women’s Entrepreneurship in managing a high-volume application process with attention to detail, accuracy, and adherence to established timelines.

Key Responsibilities – Application Cycle Management

Application Period (March-April)

• Monitor application submissions daily and track volume across award categories to ensure balanced representation
• Send application deadline reminder communications to prospective applicants
• Provide technical support to applicants experiencing issues with the online application portal
• Review incoming applications for completeness and flag missing required fields

Verification & Data Management (March – April)

• Conduct degree verification by cross-referencing applicant information with university records in ascend
• Coordinate with Registrar's office through designated liaison to verify discrepancies (minimum 2-week turnaround required)
• Verify and update applicant address information using ascend database
• Flag records with outdated or inconsistent information on tracking spreadsheets
• Follow up with individual applicants to collect missing application information after deadline
• Manage data extraction and organization for reader distribution

Reader & Judge Support (April – May)

• Maintain a record of readers and judges and properly code in data management platform
• Prepare and distribute application packets to readers, grouping applications by venture theme
• Compile and organize reader scorecards as they are returned
• Prepare semifinalist application materials for judge review
• Schedule and coordinate finalist presentation meetings
• Maintain confidential records of all evaluations and scores

(June-November)

• Administrative Support
• Maintain organized filing system for all application materials and evaluation documents
• Ensure adherence to established timeline and alert Executive Director of Women’s Entrepreneurship of potential delays
• Support communication with readers, judges, and applicants as needed
• Assist with preparation of final recommendations for approving authority
• Coordinate notification process for awardees and non-awardees by July 31 deadline
• Other duties as assigned to support the Advancement Division

Required Qualifications

• Strong attention to detail and ability to identify discrepancies in data
• Proficiency with database systems (experience with ascend preferred)
• Advanced skills in Microsoft Office Suite, particularly Excel for data management
• Experience with WordPress or similar content management systems
• Excellent organizational skills and ability to manage multiple deadlines simultaneously
• Strong written and verbal communication skills
• Ability to handle confidential information with discretion
• Demonstrated ability to work independently and problem-solve

Preferred Qualifications

• Experience with Qualtrics or Canvas learning management systems
• Familiarity with university advancement or alumni relations operations
• Knowledge of entrepreneurship or innovation programming
• Previous experience supporting awards or scholarship programs

Executive Assistant to the CEO, CFO and C-Suite Team, Boston, Mass, Hybrid

A global and innovative energy solutions company is seeking an exceptional Executive Assistant to serve as a true “right hand” to the CEO, CFO as well as help others on the C-Suite team with some administrative work. This is not a traditional administrative role, but a relational, and trust-based partnership designed to amplify the CEO's CFO’s effectiveness, clarity, and presence. The Executive Assistant will act as a stabilizing force, thoughtful gatekeeper, and intuitive collaborator, someone who understands not only what needs to be done, but how and when to do it in a way that respects people and priorities. Excellent skills using AI is a MUST as well as a “can do” problem solving persona. This is 3 or 4 days in the office depending on what is going on.

About the Job:

Trusted Partner & Strategic Support

• Act as a thought partner and sounding board, offering perspective, feedback, and quiet counsel when needed.
• Anticipate needs and proactively remove friction before issues arise.
• Prepare the CEO/CFO for meetings and conversations with context and background information; leverage AI to draft, summarize analyze and prepare materials.

Time, Energy & Focus Management

• Manage a complex and fluid calendar with an understanding of priorities and relationships, .
• Protect the CEO and CFO’s time by thoughtfully filtering requests and creating space for strategic thinking.
• Coordinate domestic and international travel including detailed itineraries.

Communication & Relationship Management

• Serve as a warm, professional liaison between the CEO/CFO and internal teams, partners, and external stakeholders.
• Draft and manage correspondence on the CEO and CFO’s behalf, ensuring tone, values, and intent are consistently reflected.

Information Flow & Follow-Through

• Distill information into clear, actionable insights for the CEO and CFO; create and edit PowerPoint presentations.
• Track commitments, decisions, and follow-ups to ensure momentum and accountability.
• Support special projects and initiatives that require coordination, and thoughtful execution.
• Plan quarterly meetings and events, dinners

About You

• Bachelor’s degree required.
• At least 5 years of experience supporting busy C-Suite executives, preferably in the tech or finance space and someone who thrives in a start- up type firm mentality.
• Strong written and verbal communication skills.
• High proficiency with Microsoft Office Suite
• Up to date and use AI Tools for daily work to increase productivity and improve processes
• Handle highly sensitive information with absolute discretion.
• High emotional intelligence and sound judgement.
• You thrive in ambiguity and are energized by anticipating needs rather than reacting to them.
• You value discretion, loyalty, and long-term partnership.
• You are highly organized, detail-oriented, and capable of managing multiple priorities without losing sight of the human element.
• You communicate with warmth, clarity, and confidence You bring polish and presence, while remaining grounded and approachable with a “high touch” service and team mentality.
• Base Salary, Discretionary Bonus, 100% Medical Health Care Coverage for Employee, Unlimited PTO

Manufacturing Engineer | Wilmington, MA

Contract-To-Hire (6-Months)

Provide engineering and project management skills in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance and troubleshooting of existing operations.

Responsibilities

• Provide strong engineering skills in support of the scale-up and development of new products and processes. This includes methods, procedures and specifications to ensure a timely transfer to Manufacturing.
• Provide strong engineering understanding on continual improvement teams, developing process methods, designing/sourcing equipment, conducting feasibility/developmental trials, executing validation requirements, drafting documents/specifications/drawings, and providing on-the-job training to ensure the effective transfer/start-up of new/refined products/processes.
• Manage equipment and process validations, including creation of the protocol, identification of test requirements, analysis and presentation of results, and creation of the final report, in accordance with internal procedures and external regulations.
• Utilize Lean Manufacturing principles and appropriate tools to drive continual improvement of key operational measures, e.g. yield, velocity, takt time, inventory, nonconformances, etc.
• Provide engineering support to manufacturing and QA groups to ensure that production requirements are satisfied.
• Prepare presentations and reports, as appropriate, to communicate status of engineering projects, progress towards goals and objectives, future opportunities, and current risks/alternatives to senior management.
• Support the site in developing, training, and maintaining calibration/preventative maintenance programs and manufacturing process controls.

Requirements

• 2+ years of experience in an engineering position within a medical device manufacturing organization or GMP/FDA Regulated Environment
• Working knowledge of Lean Manufacturing Principles
• Six Sigma Green Belt Certification a plus.
• Electro-mechanical systems experience is a plus

Salary range: 60k - 80k

Title: Operations Associate, Facilities

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.

Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and

chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market. Vaxess Manufacturing Tour

Responsibilities

• Provide support for the overall lab environment, ensuring proper functioning of utilities, lab equipment and life
• safety systems
• Perform facility & safety inspections including chemical, biological and universal waste consolidation
• Perform equipment installations, qualifications and calibrations for lab & facility equipment/casework
• Provide support to various facilities administration duties including but not limited to external vendor
• coordination, landlord services, HVAC, plumbing, etc.
• Provide support to consumable, chemical and off-site storage inventories
• Collaborate closely with cross-functional teams to support product development and manufacturing activities
• Maintain necessary certifications DOT, RCRA, Bloodborne Pathogens, etc.

Qualifications

• 2-4 years’ experience as on-site technician working in an industrial R&D, Quality Control or Manufacturing lab
• Highschool Diploma/GED is required, BS in STEM degree is a plus
• Ability to lift 50 Lbs. & work across multiple sites
• Familiarity with Lab standards, compressed gas and laboratory utilities, generators, HVAC, IT & access control
• Familiarity or experience working in GxP, a cleanroom and/or a biomedical laboratory environment
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated ability to build, repair and maintain equipment, fixtures and furniture
• 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

Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV/resume to

Salary Range: $90,000k- $115,000 (depending on experience)

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.

Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market.

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, work flows, 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 in Mechanical Engineering, Biomedical Engineering, or a related discipline
• 2 – 7 years of relevant direct R&D experience within the medical device or biopharmaceutical industries; experience working on combination products 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

Salary Range: 62k - 96k

Title: Research Associate/Senior Research Associate, Preclinical

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.

Research & development at Vaxess is cross-disciplinary, integrating basic science and engineering to transform delivery of next-generation therapies and vaccines. We are seeking a talented, collaborative, and highly motivated individual with expertise in translational animal models to join our core team of preclinical scientists and engineers. This is a unique opportunity to be part of an emerging early phase clinical company bringing innovative microneedle therapeutic delivery technology to the global market.

Responsibilities:

• Support in vivo studies, including PK and safety studies in swine. This includes preclinical animal model development and IND-enabling safety and efficacy studies across pipeline programs.
• Emphasis will be placed on coordination and participation in survival PK studies in swine
• Track ongoing animal studies, coordinating tasks from vivarium organization and test article administration to tissue harvest and downstream processing
• Ensure timely and thorough documentation of processes and learnings following in vivo studies, with an emphasis on longitudinal tracking of outcomes and compiled data summaries
• Characterize microneedle array patch (MAP) test articles deployed into preclinical models, e.g. by visual inspection, skin penetration, dose delivery and potentially other performance measurements
• Perform initial biometric tests on animals and downstream blood and tissue harvests to support bioassays that assess treatment effects
• Contribute to study design and protocol and report writing; communicate logistical needs and present work in team meetings
• Collaborate closely with scientists and engineers to advance drug candidates from research through Phase I/II clinical trials
• Maintain accurate laboratory records and electronic lab notebook entries
• Travel to testing facilities in the greater Boston area, potentially several times per week; transport test articles and equipment as needed.

Qualifications:

• Bachelor’s degree in one of the Life Sciences with at least 2 years of related work experience OR Master’s degree in one of the Life Sciences with 0-2+ years of related work experience
• Experience with large animal handling and technical procedures, particularly swine, is required; Experience with large animal research models and PK studies is considered a plus
• Strong organizational skills and attention to detail
• Excellent verbal and written communication skills
• Committed to working collaboratively with an interdisciplinary team

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: 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