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Job Title: Food & Beverage Director

Location: Boston, MA

Salary: BOE

Skills: Food & Beverage Operations, P&L Management, Team Leadership, Banquet & Catering Management, Guest Service Excellence

About Company / Opportunity:

Located in Boston’s historic district, this luxury property combines timeless elegance with modern sophistication. It offers exceptional dining, curated events, and personalized service, making it a premier destination for both business and leisure travelers.

Responsibilities:

The Food & Beverage Director is a senior executive leader responsible for driving the overall strategy, financial performance, and operational excellence of the hotel’s Food & Beverage division. This role oversees all dining outlets, bar/lounges, banquets, catering, and in-room dining, ensuring an exceptional guest experience aligned with luxury hospitality standards. The Director partners closely with the General Manager and Executive Leadership Team to maximize revenue, elevate service standards, and position the hotel as a premier dining destination in Boston.

• Develop and execute a comprehensive Food & Beverage strategy aligned with overall hotel goals
• Collaborate with executive leadership on revenue growth initiatives and brand positioning
• Lead, mentor, and develop department heads and F&B leadership teams
• Foster a culture of service excellence, accountability, and continuous improvement

• Oversee all F&B outlets including restaurants, bars, banquets, and in-room dining
• Ensure consistent execution of service standards and guest experience across all touchpoints
• Maintain strong on-floor presence during peak periods and high-profile events
• Drive innovation in menus, concepts, and guest offerings to remain competitive in the Boston market

• Own full P&L responsibility for the F&B division
• Lead budgeting, forecasting, and financial planning processes
• Monitor and control food, beverage, and labor costs to meet or exceed targets
• Analyze performance metrics and implement strategies to improve profitability

• Partner with Sales & Catering to maximize banquet and event revenue
• Oversee menu engineering, pricing strategies, and cost analysis
• Identify new revenue streams, promotions, and partnership opportunities

• Recruit, train, and retain top F&B talent
• Implement training programs to ensure high service and operational standards
• Promote a positive, inclusive, and high-performance work environment
• Ensure compliance with labor laws and company policies

• Ensure all outlets deliver exceptional, consistent guest service
• Respond to guest feedback and implement service improvements
• Uphold luxury hospitality standards and brand reputation

• 5–10+ years of progressive Food & Beverage leadership experience, preferably in luxury or upscale hotels
• Proven experience managing high-volume hotel or resort operations
• Strong financial acumen with experience managing budgets, forecasting, and P&L
• Demonstrated success in team leadership, training, and culture building
• Experience in union environments (preferred for Boston market)
• Bachelor’s degree in Hospitality Management, Business, or related field (preferred)

• Strategic thinking and business acumen
• Operational excellence and attention to detail
• Leadership and team development
• Guest-focused mindset
• Innovation in culinary and beverage programming
• Strong communication and stakeholder management

Harness is the AI Software Delivery Platform company, led by technologist and entrepreneur Jyoti Bansal (founder of AppDynamics, acquired by Cisco for $3.7B). Harness has raised approximately $570M in funding and is valued at $5.5B, backed by leading investors including Goldman Sachs, Menlo Ventures, IVP, Unusual Ventures, Citi Ventures, and more. As AI accelerates code creation, the real bottleneck has shifted to everything after the code testing, deployments, application security, reliability, compliance, and cost optimization. Harness brings AI and automation to this \"outer loop,\" helping teams ship software faster while maintaining security and governance throughout the entire software delivery lifecycle.

Powered by Harness AI and the Software Delivery Knowledge Graph, the Harness Platform applies deep context and intelligent automation across the software delivery lifecycle with governance and policy-driven controls embedded throughout the platform.

Over the past year, Harness powered over 185M deployments, 82M builds, 18T flag evaluations, 8M security scans, 9.1B optimized tests, 3T protected API calls, and helped manage $2.8B in cloud spend enabling customers like United Airlines, Morningstar, and Choice Hotels to accelerate releases by up to 75%, reduce cloud costs by up to 60%, and achieve 10x DevOps efficiency.

With a global team across 14 offices and 25 countries, Harness is shaping the future of AI software delivery and we're looking for exceptional talent to help us move even faster.

Harness is looking for sales champions and leaders who are as passionate about building the next great software company as they are about blowing out their numbers every quarter.

• Exceeding your number- Winning new logos
• Forecasting correctly, communicating clearly, aligning brilliantly with the rest of the team
• Not being afraid of being data driven - including using Salesforce and other tools to track your progress
• Managing full sales cycle from prospect to close
• Collaborating with other teams, including sales engineering and sales development

• A proven track record of driving and closing deals
• Account planning and execution skills
• Ability to sell C-Level and across both IT and business units
• Consistent overachievement of quota and revenue goals with a strong W2 track record
• Understands the value of utilizing a strong sales methodology such as MEDDIC when building pipeline and qualifying opportunities
• Proven consultative sales solution skills, including the ability to articulate a clear, concise return on investment value statement
• Ability to maintain a high level of productivity, manage multiple competing priorities, and work effectively under the pressure of time constraints in a fast-paced, complex, collaborative, and team-oriented environment
• Bachelors Degree or equivalent

This role is based in our Boston, MA office.

• Competitive salary
• Comprehensive healthcare benefits
• Flexible Spending Account (FSA)
• Employee Assistance Program (EAP)
• Flexible Time Off and Parental Leave
• Quarterly Harness TGIF-Off / 4 days
• Monthly, quarterly, and annual social and team-building events
• Recharge & Reset Program
• Monthly internet reimbursement
• Commuter benefits

The OTE for this position is $220,000. Factors that may be used to determine your actual pay rate include your specific skills, experience, qualifications, location, and comparison to other employees already in this role. In addition to the base salary, certain roles may qualify for a performance-based incentive and/or equity, with eligibility depending on the position. These rewards are based on a combination of company performance and individual achievements. A valid authorization to work in the U.S. is required.

The Associate Director, Omnichannel & Marketing Capabilities is a hybrid strategic and technical leader responsible for defining and building the marketing technology infrastructure that powers Galderma's US commercial business. This role acts as the primary bridge between business strategy and technical execution, serving the four major US business units. This individual will lead the design and implementation of the technical roadmap, with a specific hands-on focus on Salesforce Marketing Cloud and Journey Builder to orchestrate complex customer experiences. This high-visibility role will partner closely with Omnichannel Leads, Brand Marketers, and IT to translate commercial vision into a functional reality, ensuring campaigns are data-informed, automated, and scalable.

Location: Boston, MA (Hybrid)

Essential Functions:

Marketing Technology Roadmap & Solution Architecture

• Define and own the technical capability roadmap, translating high-level business requirements from Brand and Omnichannel Leads into specific technical specifications and architectural designs.
• Serve as the primary technical liaison between commercial business units and IT/Global Tech teams to prioritize and implement new platform features, connectors, and integrations.
• Design scalable solution frameworks that allow for \"build once, deploy many\" capabilities across the four Galderma business units to reduce duplication and technical debt.
• Evaluate and recommend new technical tools or plug-ins within the MarTech stack (e.g., SMS aggregators, webinar connectors) to support evolving campaign needs.

Salesforce Marketing Cloud (SFMC) Operations & Execution:

• Serve as the hands-on technical administrator and architect for Salesforce Marketing Cloud, directly managing Journey Builder, Automation Studio, and Contact Builder.
• Build, test, and deploy complex, multi-step customer journeys, utilizing advanced logic (decision splits, engagement triggers) and scripting (AMPscript, SQL) to ensure flawless execution.
• Oversee the end-to-end technical production process, including audience segmentation setup, email/SMS rendering QA, and final deployment scheduling.
• Troubleshoot technical issues within the platform (e.g., API failures, data sync errors, email rendering issues) and resolve them rapidly to minimize business disruption.

Data Activation, CDP & Personalization:

• Lead the technical implementation of Customer Data Platform (CDP) use cases, configuring data ingestion rules and identity resolution logic to create unified customer profiles.
• Develop and maintain the data schema and segmentation logic required to power \"Next Best Action\" and dynamic content personalization across channels.
• Ensure all campaigns are technically configured for accurate measurement from day one, implementing proper tracking tags, parameters, and feedback loops into the data warehouse.

Governance, Vendor Management & Enablement:

• Establish and enforce technical governance standards, including naming conventions, folder structures, and data privacy compliance (consent management/opt-outs) within the platforms.
• Manage the technical output of external development vendors and agencies, reviewing their code and configuration to ensure it meets Galderma's quality and security standards.
• Create and maintain technical documentation (playbooks, data dictionaries, process flows) to support knowledge transfer and operational consistency.

Minimum Education, Knowledge, Skills:

• 8+ years of progressive experience in marketing operations, marketing technology, or digital transformation.
• Deep, hands-on technical proficiency with Salesforce Marketing Cloud, specifically Journey Builder, Email Studio, and Automation Studio.
• Experience in the pharmaceutical, biotech, or healthcare industry is preferred, but not required; experience in highly regulated industries is a plus.

Technical & Functional Skills:

• Proven experience building and managing a marketing technology roadmap and translating business needs into technical specifications.
• Experience implementing or utilizing a Customer Data Platform (CDP) (e.g., Salesforce Data Cloud, Tealium, Adobe) to drive segmentation and personalization.
• Strong understanding of HTML, AMPscript, and SQL basics for audience segmentation and content personalization.
• Demonstrated success in establishing a new capability or function within a complex, matrixed organization.
• Ability to lead through influence, bridging the gap between creative marketers and technical engineering/IT teams
• Strong knowledge of healthcare compliance guidelines, FDA regulations, and privacy standards (PRC process).
• Proven ability to lead through influence and drive change in a complex, matrix-driven organization.
• Experience in capability assessment frameworks and competency modeling.
• Experience managing external agencies and strategic vendors.
• ~10% travel.

Competencies & Abilities:

• Strategic Thinking Shapes training strategy to support commercial objectives.
• Leadership & Influence Inspires and guides peers, field teams, and stakeholders.
• Advanced Instructional Design Builds sophisticated, learner-centered solutions.
• Project & Change Management Leads complex, multi-phase initiatives.
• Analytical Insight Uses data to inform decisions and demonstrate value.
• Innovation & Agility Adopts new approaches and pivots quickly in dynamic markets.

About the Compensation:

The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the hiring range for this role is $170,000-$210,000.

In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance. We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more.

What we offer in return:

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

Next Steps:

• If your profile is a match, we will invite you for a first conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference:

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

FLSA Status: Exempt

Department: Food and Beverage Kitchen

Reports to: Chef De Cuisine & General Manager

Purpose:

The Chef is directly responsible for the cost-effective operation of a clean and safe kitchen while meeting or exceeding food quality and speed of service requirements. The Chef works as part of the management team of the restaurant to build sales and grow the business and is responsible for operating a profitable restaurant, where the quality of food, service and ambience are continually challenged and improved, and where an environment that fosters creativity, free thinking and intelligent decision-making is encouraged.

The Chef is expected to work an average of 5055 hours per week.

Essential Duties:

-Creating and maintaining an upbeat, productive, and educational environment.

- Projecting a positive attitude.

- Showing respect for all employees and actively cultivating an inclusive environment build upon

mutual respect, civility, and positivity.

- Providing ongoing training and constant improvement of product and workplace (i.e., safety,

sanitation and systems).

- Setting the pace and tone of the kitchen and overall restaurant through attitude,

initiative and drive.

- Providing feedback and direction to BOH employees, to continue ongoing development.

-Helping to develop a cohesive team and leading them to work toward the common goals of the

restaurant.

- Possessing a high level of initiative and drive to do whatever is necessary to build and run a

successful operation.

- Working closely with the General manager to create a team atmosphere among the entire staff that is both a positive and professional work environment.

- Leading by example, taking an active role in cooking and supervising the line during dinner service.

- Participate in mini meetings with FOH management on a regular basis to ensure clear line of communication and upkeep of company goals.

- Establishing clear communications along all lines within the business.

Building the Business and Guest Base

- Aggressively working to build food sales by operating the kitchen with a guest-satisfaction mentality.

- Making decisions based on what is best for the guest.

- Solving problems so that each guest will want to return.

-Working with the GM and front of house manager to train staff on product knowledge.

Quality of Operations

-The Chef is responsible for ensuring that the restaurant is operating at or above company standards. The

-Chef must pay attention to detail in all areas of the operation, including food quality and consistency, training

and development, security, safety, sanitation, and physical structure.

Specifically:

- Ensuring strict adherence to standards for food quality.

- Demonstrating commitment to cultivating knowledgeable staff members who are proud of our

quality and believe in our concept.

- Ensuring all Health Department regulations are always enforced.

Cost Management and Profitability

The Chef is responsible for generating strong financial performance for the health of the restaurant and the

company. They are ultimately responsible for ensuring that the food and BOH labor costs meet or exceed

budgeted financial goals.

Specifically:

- Working proactively with the General Manager to maximize sales and optimize profits through the

management of food and labor costs.

- Food COGS goal of 28% or less.

- Total Kitchen Labor goal of 11%

- Analyzing weekly costs to ensure proactive management of controllable costs.

- Assuming full responsibility for:

- Monitoring daily BOH labor reports and minimizing overtime.

- Providing a monthly physical inventory

- Maintaining the valuations on your inventory using invoices from vendor

- Purchasing and Receiving

- Monitoring local vendors accordingly.

- Placing effective orders, based on sales, while simultaneously taking advantage of drop size

incentives.

- Proper receiving, rotation, storage, and handling of all food products.

Production

- Taking a hands-on approach and being directly involved in daily production.

- Setting appropriate prep levels (sales versus usage) to ensure fresh product and effective use of

labor, including:

- Daily prep counts.

- Weekly prep totals and weekly prep plans.

- Regular review of Product Mix (P-Mix) information.

Personnel

The Chef is responsible for overseeing all aspects of kitchen staffing and is responsible for the hiring and

scheduling of quality employees to execute the menu successfully and to maintain the smooth flow of

kitchen operations.

Specifically:

- Establishing and maintaining appropriate staffing levels and remaining abreast of any changes that may

impact staffing needs.

- Keeping the GM informed of all staffing needs.

- Ensuring thorough and complete training of all employees, including kitchen operations, knife

safety, proper handling of product, use of chemicals, use of equipment, etc.

- Minimizing employee turnover.

- Providing coaching, mentoring and development to all employees as this is critical for the

success of the restaurant and the company.

- Mentoring, coaching and developing Sous Chef Donald Readington to be an extension of yourself. Sous

development should include; menu engineering, systems development, training systems, vendor

negotiations and kitchen management.

- Providing consistent and frequent feedback to Sous Chef(s) and staff.

- Teaching and coaching staff daily.

- Holding BOH meetings to review specials, menu items and discuss kitchen issues.

- Attending FOH Pre-Meals to review specials, menu items and discuss kitchen issues.

- Producing an accurate forecast

Administration

- Overseeing the creation and implementation of all menus.

- Ensure all menu changes are rolled out according to The Terrace Rooftop Dining procedures

- Ensuring that performance reviews of all BOH employees are completed annually

Facility and Equipment

The Chef is responsible for the daily upkeep of the physical restaurant/kitchen, specifically:

- Providing a daily walk through of the kitchen to determine areas needing attention or repair.

- Maintaining a running punch list of need to have as well as nice to have items which are

handled in a timely fashion as appropriate.

- Planning necessary upgrades in a timely, well thought out way.

- Calling appropriate repair companies

- Keeping The Terrace Leadership informed of all necessary repairs and logging repairs and

Maintenance.

This job description is not an exclusive or exhaustive list of all job functions that an associate in this position may be asked to perform from time to time.

Compensation details: 75 Yearly Salary

PI152e172c56af-26289-39969973

Boston, Massachusetts

Capital Planning Construction Administration

Full-Time Hybrid

Project Manager 1 - Construction Administration

Capital Planning

Reports To: Project Manager 3 Construction Administration

Exempt

Grade: 10

This Project Manager 1 position is a member of the MSBA's Construction Administration Team that manages MSBA-funded capital projects from design development through bidding, contract award, construction, commissioning, and project close-out. The Project Manager 1 works with a motivated team reporting to a Project Manager3 for major projects and repair projects. The Project Manager 1 works with public school districts and consultants as part of a MSBA team to ensure conformance with MSBA's policies, agreements, and practices for major projects and repair projects through design development, construction and final audit. The Project Manager 1 will also review district submittals that establish grants for the repair program.

• Monitor project schedules, budgets and scope for major construction and repair projects to ensure compliance with MSBA guidelines and funding agreements, and to track construction progress.
• Review monthly reimbursement requests for major construction and repair projects and recommend eligibility of project costs for reimbursement.
• Report on changes to the schematic design budget through the design development and bidding phases, process budget revisions, and review project cash flow for accuracy and variances.
• Review design development documents and prepare and issue review comments for major projects, identifying any variances to the agreed upon scope identified in the funding agreement.
• Review cost estimates, project scope and budget submittal to establish the grant for repair projects.
• Prepare and review change order documentation including recommendation of change order eligibility on major construction and repair projects.
• Review monthly project reports to understand submittal status, contract compliance, construction progress and identify variances. Utilize this information as well as lead site visits to inform MSBA reporting to the Board of Directors.
• Collaborate with the project team to review and make recommendations to improve MSBA processes and inform best practices for school construction.
• Lead in project meetings addressing project status, funding agreements, amendments and change orders.
• Collaborate with the project team to develop a schedule for the timely submittal of all final documents required for final audit of major construction and repair projects. Coordinate with the project team to resolve any outstanding items required and reconcile and approve the final payment.
• Participate in Capital Planning and Construction Administration subcommittees and procurement committees, on an as needed basis.
• Participate in the preparation, coordination and presentation of materials required for MSBA subcommittee, roundtables and Board of Director Meetings.

• Bachelor's degree in one of the following: project management, construction, architecture, engineering, or a related field.
• Two-to-five years of experience associated with construction, project management, building design or other applicable disciplines.
• Knowledge of construction project administration, contract compliance monitoring, change orders and construction methods.
• Proficiency in Microsoft Office software applications, including Excel, Word, PowerPoint and Outlook.
• Ability to effectively manage multiple tasks, involving complex and varying problems.
• Strong verbal and written communication skills.
• Demonstrated ability to gather, analyze, and present complex technical information in a clear, concise, and understandable manner.
• Ability to work both independently and as part of a team.
• Ability and willingness to travel occasionally to project sites.

$78,425 - $86,267 a year

This job description is intended to be general and will evolve over time. The description is subject to periodic updating. At management's discretion, the employee may be assigned different or additional duties from time to time.

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

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

About the Role

We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity.

You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems.

What You’ll Do

Lead the Quality Function

• Own and continuously improve our Quality Management System (QMS)
• Lead and develop a small but growing quality team
• Establish KPIs and reporting for executive leadership
• Serve as the quality voice at the leadership table

Ensure Regulatory Compliance

• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR
• Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits
• Support regulatory submissions from a quality perspective
• Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment

Support Product Development

• Embed Design Controls into hardware and software development processes
• Ensure compliance with IEC 62304 for software lifecycle processes
• Oversee risk management activities (ISO 14971), including FMEA and hazard analysis
• Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring)

Post-Market & CAPA

• Oversee complaint handling, MDR reporting, and CAPA processes
• Drive investigations and ensure root cause analyses are thorough and actionable
• Use data trending to proactively identify quality risks

Supplier & Manufacturing Quality

• Establish and maintain supplier qualification and audit processes
• Oversee incoming inspection and production quality controls
• Partner with Operations to ensure scalable manufacturing processes

What you'll do

Experience

• 10+ years in quality roles within medical devices or regulated healthcare software
• At least 3–5 years in a leadership capacity
• Direct experience with FDA inspections and ISO 13485 audits
• Experience supporting both hardware and software products
• Familiarity with AI/ML in a regulated environment strongly preferred

Technical Knowledge

• Deep understanding of:
• FDA QSR (21 CFR 820) and ISO 13485
• ISO 14971 risk management
• IEC 62304 software lifecycle requirements
• Working knowledge of Agile/Scrum environments
• Comfort reviewing technical documentation and working closely with engineers and data scientists

Leadership Style

• Hands-on and pragmatic
• Comfortable operating in ambiguity and growth environments
• Able to push back when needed
• Strong communicator with auditors, executives, and technical teams

Nice to Have

• Experience with Software as a Medical Device (SaMD)
• Background in AI/ML model governance or data quality controls
• ASQ certification (CQE, CMQ/OE, etc.)
• Prior experience in venture-backed or scaling organizations

*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.

W-2 employees only. No 3rd parties.

• 8+ years in Technical Program Management, Digital Transformation, or Engineering Program Delivery.
• 3+ years leading AI/ML or advanced analytics initiatives.
• Experience in regulated industries (Pharma, Biotech, Medical Devices).
• Strong understanding of AI/ML lifecycle and data governance.
• Experience working with enterprise platforms (LIMS, MES, SAP, Veeva, etc.).
• Strong stakeholder management and executive communication skills.