Information Technology Jobs in Sonoma

345 positions found — Page 6

Physician / Dermatology / California / Permanent / CaliforniaDermatologist Needed Near San Jose - Positive Work-Life Balance! - Gilroy, CA Job
✦ New
Salary not disclosed
Novato, California 1 hour ago
Excellent Opportunity for a Dermatology Physician in California's Central Valley Region

Job

Less than 35 minutes from downtown San Jose

myDermRecruiter is actively seeking aBoard-Certified/Board-Eligible Dermatologistto join a highly successful practice in California's Central Valley Region.

Step into a well-established practice in a vastly underserved market and grow your career alongside a close-knit team of experienced providers eager to welcome a friendly new physician to their team!

Find all of the position details and how to apply below.

About the Position:
  • Open to MDs, DOs, and Residents - immediate need!
  • Full-time; 4 days per week -excellent work-life balance!
  • Current providers see 35-45 patients per day
  • See patients for Medical Dermatology
  • Position available due to practice growth and patient demand
Compensation Details:
  • Highly competitive compensation plan
  • Complete benefits package including a 401k plan
  • Potential Sign-on Bonus + Relocation Assistance
Practice Highlights:
  • Small, collegial team of providers
  • A warm, welcoming clinic atmosphere
  • Work alongside several reputable physicians
  • Excellent support staff ensures your focus as a provider remains on patient care
  • Focused on serving patients with the highest quality of care and personalized treatment plans
  • Modern office featuring state-of-the-art equipment and technology
Location Features:

If living in California's Central Valley Region sounds like a dream come true, this opportunity is perfect for you!

You'll be just 35 minutes from beautiful San Jose and 75 minutes from San Fransisco. In a half day's drive, you could be in Los Angeles from here, too!

There are excellent public schools in the area and a solid family-friendly atmosphere, making this ideal for families. A few area attractions you won't want to miss:

  • Municipal Rose Garden
  • The Golden Gate Bridge
  • Sierra Azul Preserve
  • Winchester Mystery House
  • Walt Disney Family Museum
  • Henry W. Coe State Park

In just 45 minutes, you can be enjoying Pacific Coast beaches, too! And when you're ready for a getaway, just head toSan Jose International Airport!

Ready to Make a Career Move?

If career satisfaction is your goal, then you've come to the right place!

Request aconfidential conversationwith one of myDermRecruiter's talented Dermatology Recruitment Specialists today!

There's never a fee for job seekers and you can trust that all inquiries will be held strictly confidential.

For immediate consideration, call David Dickens at ext 130today. Or email your CV to.

David Dickens Dermatology Recruitment Specialist Ext. 130
permanent
Manufacturing Specialist
✦ New
Salary not disclosed
Novato, California 1 day ago

Manufacturing Associate

Shift is alternating Saturdays, Sunday-Tuesday (6pm to 7am)

Duration: 1 year contract

Pay Range: $27.00 - $28.00

PROCESS KNOWLEDGE:

Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).

TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.

QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.

WORK ENVIRONMENT/PHYSICAL DEMANDS

• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.

• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.

• May require work around loud equipment. • The use of personal protective equipment will be required.

• Requires various shift based work and off hours.

Skills

•Strong communication skills—verbal and written

•Ability to work in a team environment which includes good conflict resolution and collaboration

•Displays good initiative to identify areas for improvement and implement solutions

Education

-Bachelor's degree in science related area or engineering

-Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

Benefits (employee contribution):

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Not Specified
Litigation Partner or Group (Commercial, Securities, Class Actions, White Collar & Regulatory Attorneys) for Fast-Growing AmLaw Firm
✦ New
Salary not disclosed
Sonoma, CA 2 hours ago

Litigation Partner / Group

Commercial • Securities • Class Actions • White Collar • Regulatory

Fast-Growing AmLaw Firm | Nationwide Platform

We are representing a fast-growing AmLaw firm actively building a national litigation platform across complex commercial disputes, securities litigation, class actions, government investigations, and trial work. The firm is making significant strategic investments in lateral partners and groups who want stronger economics, deeper institutional support, and a platform designed to scale high-stakes litigation practices.

This is an opportunity for trial-tested rainmakers who want more than a department — it is built for partners who want cross-selling, premium clients, and a firm that actively invests in their success.

The Platform

The firm represents Fortune 500 companies, financial institutions, private equity sponsors, asset managers, technology companies, and regulated businesses in some of the most complex and high-exposure matters in the market. Litigation partners operate inside a fully integrated platform that includes corporate, securities, regulatory, IP, and employment, allowing clients to manage risk and disputes across their entire enterprise.

The practice supports matters including:

  • Complex commercial and business litigation
  • Securities litigation, shareholder derivative and fiduciary-duty actions
  • Class actions and mass tort defense
  • Antitrust and competition disputes
  • White-collar criminal defense and government investigations
  • Regulatory enforcement (SEC, DOJ, FINRA, CFTC, state AGs)
  • Internal investigations and compliance matters
  • Trade secrets, unfair competition, and business torts
  • Appellate litigation and trial strategy

Who They’re Looking For

The firm is seeking partners — and partner groups — with:

  • A portable book of business
  • Practices in commercial litigation, securities, regulatory, white collar, or class action defense
  • Interest in a platform that delivers real institutional support and cross-practice client expansion

Books typically begin in the mid-six figures and above, with flexibility based on practice mix, clients, and growth potential.

Why Partners Join This Platform

This firm offers:

  • AmLaw-level sophistication with entrepreneurial economics
  • National footprint with flexible office alignment
  • Deep corporate, PE, and regulatory cross-selling
  • Elite trial teams, e-discovery, and litigation support
  • Real marketing and business-development infrastructure
  • Leadership opportunities to shape the litigation platform

Partners move here because they want more leverage, more referrals, and more upside — without BigLaw bureaucracy.

Explore Confidentially

All inquiries are handled in strict confidence.

If you are exploring a platform that offers stronger economics, premium disputes, and real growth support, we welcome a discreet conversation.

Not Specified
Senior Manufacturing Process Engineer
Salary not disclosed
Sonoma, CA 4 days ago

Senior Manufacturing Process Engineer

Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the San Francisco Bay area. The company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an experienced Manufacturing Process Engineer to support NPI of electro-mechanical devices in collaboration with suppliers.


This role will focus on hands-on interaction with suppliers to develop manufacturing processes, tooling, and documentation, from design feasability through commercial release. This role will require real-time engagement and technical support of suppliers, and this individual will be expected to travel often to domestic supplier sites and occasionally to international suppliers.


Primary Responsibilities:

  • Serve as the primary technical liaison to external manufacturing partners, ensuring successful delivery of components, assemblies, and finished devices
  • Collaborate with product development teams to ensure designs are manufacturable and compliant with medical device quality system requirements
  • Develop and maintain manufacturing documentation, including work instructions, process flows, and validation protocols
  • Support supplier implementation of specifications, manufacturing processes, and quality requirements
  • Lead and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations
  • Drive continuous improvement initiatives related to manufacturing efficiency, quality, cost, and scalability
  • Support resolution of non-conformances and corrective actions with suppliers
  • Ensure manufacturing activities comply with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.)
  • Provide hands-on technical support to suppliers, including travel as needed (domestic and international)


Role Requirements:

  • B.S. in relevant engineering discipline, or equivalent experience.
  • 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
  • Experience with active implantable systems (Implant, Leads, Externals, etc.).
  • Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
  • Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
  • Experience with manufacturing automation.
  • Experience in defining and executing process validation activities.
  • Experience collaborating with internal customers and external partners.
  • Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
  • Experience with Solidworks, Labview / manufacturing process and test automation software.
  • Ability to travel to Domestic and International supplier sites frequently
Not Specified
Head of Operations and Manufacturing
Salary not disclosed
Sonoma, CA 4 days ago

Head of Operations and Manufacturing Ripple Medical | California (Hybrid or Remote) | Full-Time


ABOUT RIPPLE MEDICAL

Ripple Medical is a health tech company on a mission to revolutionize hypertension management with our cuffless blood pressure wearable. Once cleared by FDA, our product will enable patients to easily and accurately monitor blood pressure at home, empowering them and their providers with actionable data to improve outcomes. We're a collaborative, mission-driven team of 33 working in a medical device regulatory environment to bring this technology to the millions of patients who can benefit.


POSITION SUMMARY

The Head of Operations and Manufacturing will own the end-to-end operational infrastructure required to bring Ripple's FDA-regulated cuffless blood pressure monitor to market and scale production. This is a hands-on leadership role for someone who thrives building from zero to one in a regulated environment: selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820, establishing ISO 13485-certified quality management systems, and preparing for direct-to-patient fulfillment.

As a company preparing for 510(k) submission and commercial launch, this role is critical to ensuring we can reliably manufacture and deliver a high-quality, FDA-cleared medical device at scale. The ideal candidate brings deep experience in medical device manufacturing (particularly wearable or electro-optical devices), understands regulated hardware supply chains and design transfer, and can roll up their sleeves while building the team and processes for long-term growth.

This position reports directly to the CEO with high visibility to the leadership team and Board of Directors.


KEY RESPONSIBILITIES

Manufacturing & Production

  • Lead selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ, quality audits, contract negotiation, and ongoing management.
  • Own design transfer and manufacturing transfer, working with engineering on DFM principles, Device Master Record (DMR) requirements, and production readiness.
  • Establish production planning, forecasting, and capacity management for V&V builds, pilot production, and volume manufacturing.
  • Drive continuous improvement in yield, quality, and cost while maintaining FDA and ISO compliance.
  • Oversee pilot runs and scale-up, including process validation (IQ/OQ/PQ) and manufacturing controls.

Supply Chain & Procurement

  • Build and manage the end-to-end supply chain, including component sourcing, supplier qualification, and inventory management per FDA purchasing controls.
  • Develop supplier relationships and negotiate terms while ensuring supply continuity, traceability, and risk mitigation.
  • Implement inventory planning to balance working capital with service levels, including buffer strategies for Year 1 launch.
  • Monitor and mitigate supply chain risks: component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.

Quality & Regulatory Compliance

  • Maintain and improve the ISO 13485-certified QMS in partnership with the quality and regulatory team, ensuring FDA 21 CFR Part 820 compliance.
  • Support 510(k) submission activities related to manufacturing, including process validation documentation, DMR development, and device history records (DHR).
  • Define incoming inspection, in-process controls, and final product testing consistent with the risk management file.
  • Manage product certifications for a Class II device, including FDA registration, UDI compliance, and applicable international requirements.
  • Lead root cause analysis and CAPA for quality issues, ensuring post-market surveillance compliance.

Fulfillment & Logistics

  • Design the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience.
  • Establish logistics and distribution for nationwide shipping of a regulated device with chain-of-custody and traceability.
  • Develop returns, replacement, and warranty processes that balance patient experience, cost, and compliance.

Team & Organizational Development

  • Start as an individual contributor who executes hands-on, then build and lead the operations team through 510(k) clearance and commercial launch.
  • Establish operational metrics and dashboards for manufacturing, supply chain, and quality performance.
  • Partner with finance on cost modeling, COGS optimization, and operational budgeting.
  • Collaborate cross-functionally with engineering, software, regulatory, and commercial teams.


QUALIFICATIONS

  • 7-12 years in manufacturing, operations, or supply chain, with 3-5+ years in medical devices (Class II preferred), wearables, or regulated hardware.
  • Experience managing contract manufacturers for regulated medical devices, preferably in Asia and/or domestically.
  • Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.
  • Track record of design transfer and scaling production from pilot to volume for regulated products.
  • ISO 13485 and FDA 21 CFR Part 820 experience required.
  • Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.
  • Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field; MBA or advanced degree a plus.
  • Based in California or travel up to 25%.

COMPENSATION

  • Base Salary: $160,000 - $210,000 USD
  • Performance Bonus: Tied to company milestones and personal objectives
  • Equity: Early-stage stock option grant with meaningful ownership
  • 100% Employer-Paid Healthcare: Medical, dental, and vision
  • Additional Benefits: 401(k) with company match, flexible PTO
Not Specified
Lead PMIC Design Engineer (RTL)
✦ New
🏢 SBT
Salary not disclosed
Sonoma, CA 1 day ago

SBT is the exclusive retained recruiting firm for this position.


Company Overview

This confidential startup is a well-funded early-stage semiconductor company focused on advancing AI-driven design to address emerging challenges in the artificial intelligence ecosystem. The company is developing innovative technologies that leverage automation and machine learning to accelerate the design and development of complex analog semiconductor solutions. By applying AI to traditionally manual and time-intensive design processes, the organization aims to unlock faster innovation cycles and enable the next generation of AI hardware infrastructure.


Job Role

  • Design and implement digital control logic for power management ICs
  • Work closely with analog engineering teams to ensure effective integration between digital control blocks and analog power circuitry
  • Develop high-quality, power-efficient RTL using Verilog or SystemVerilog to support key features
  • Contribute to product readiness for manufacturing by supporting design-for-test methodologies
  • Create and execute comprehensive verification strategies, including mixed-signal simulations and behavioral modeling


Qualifications

  • BS or MS degree in Electrical Engineering, Computer Engineering, or a related field.
  • 10+ years of experience in digital IC design, including significant experience developing solutions for mixed-signal or power management semiconductor products.
  • Strong proficiency in RTL development using Verilog or SystemVerilog for synthesizable digital design.
  • Hands-on experience designing digital control logic for power conversion systems, including control loops used in power management or DC-DC converter applications.
Not Specified
Private Equity Associate/Senior Associate
✦ New
Salary not disclosed
Sonoma, CA 1 day ago

About the firm:

This San Francisco‑area private equity firm specializes in providing growth capital and structured financing to established, founder‑led tech and technology‑enabled services companies in the U.S., typically investing in lower‑middle‑market businesses that haven’t had prior institutional funding. It partners with business owners by offering capital along with strategic, operational support to help these companies scale, accelerate growth, and become market leaders, while often taking minority stakes and aligning incentives without forcing founders to give up control.


About the role:

  • Deal Sourcing & Screening: Research and identify potential investment opportunities in tech and tech-enabled companies.
  • Financial Analysis & Modeling: Build detailed financial models, perform valuations, and assess potential returns and risks.
  • Due Diligence: Support the evaluation of target companies, including market research, competitive analysis, and operational reviews.
  • Investment Memoranda: Prepare presentations and investment memos for internal committees and decision-makers.
  • Portfolio Support: Assist portfolio companies with growth initiatives, performance tracking, and strategic projects post-investment.
Not Specified
Director of Environmental Services
Salary not disclosed
Sonoma, CA 4 days ago

Sequoia Living – San Francisco High-Rise Community


Sequoia Living is seeking an experienced, mission-driven Director of Environmental Services to lead operations in our high-rise community. This is a highly visible leadership role responsible for creating a safe, clean, efficient, and beautifully maintained environment for the residents who call our community home.


If you are a hands-on, solutions oriented facilities professional who thrives in a dynamic environment and you are passionate about leading teams, elevating service standards, and improving the daily lived experience of residents this is a unique opportunity to make a meaningful impact.


Experience in a CCRC, senior living, healthcare, assisted living, or hospital setting is required.


Why This Role Matters

As the Director of Environmental Services, you are the operational backbone of the community. You ensure residents live in a well-maintained, safe, and welcoming environment while leading a diverse and dedicated team across plant operations, maintenance, housekeeping, laundry, landscaping, safety, and construction oversight. Your work directly impacts resident experience, staff satisfaction, regulatory compliance, and long-term asset preservation.


What You’ll Do (Key Responsibilities)

Leadership & Department Oversight

  • Lead all Environmental Services functions, including plant operations, maintenance, housekeeping, laundry, landscaping, and safety programs.
  • Recruit, hire, mentor, and develop supervisors and frontline staff; foster a culture aligned with Sequoia Living’s Mission, Vision, Values, and Commitment to Inclusion.
  • Manage administrative operations, staff schedules, training, coaching, and performance review processes.


Facility Operations & Maintenance

  • Oversee the community’s preventative and corrective maintenance programs, ensuring compliance with all Federal, State, and local regulations (EPA, ADA, OSHA/OSHPD, Titles 8, 19, 22 & 24).
  • Review maintenance projects, repairs, and inventory needs; recommend improvement plans to community leadership and the Director of Design & Construction.
  • Ensure the community’s safety programs (Fire, Disaster, Emergency Response, Hazardous Materials Plans) are up-to-date and fully implemented.
  • Train staff in safe work practices, including asbestos and industrial chemical handling.


Construction, Capital Projects & Renovations

  • Manage capital project planning and execution, including apartment renovations, building upgrades, and major infrastructure improvements.
  • Maintain computerized capital budget tools, plan expenditures, and ensure timely project completion.
  • Solicit and evaluate contractor bids; manage vendor relationships, permits, and certificates of insurance.


Budgeting & Resource Management

  • Prepare and manage operating and capital budgets; track expenses and ensure cost control.
  • Oversee energy conservation and utility monitoring to optimize efficiency.


Resident & Community Engagement

  • Serve as a responsive partner to residents and committees on maintenance needs and special projects.
  • Communicate professionally and collaboratively with department heads, staff, vendors, regulatory bodies, and Sequoia Living leadership.


Risk, Safety & Compliance

  • Act as the community’s Safety Coordinator: oversee workplace safety programs, ensure incident reporting, support workers’ compensation processes, and lead safety initiatives.
  • Identify and report resident concerns related to physical, mental, or emotional well-being.
  • Participate in on-call rotation and support emergency response as needed.


What You Bring (Qualifications)

Experience

  • 6+ years of hands-on experience in environmental services, facilities management, plant operations, or maintenance preferably in healthcare, senior living, or a residential community.
  • 3+ years of supervisory or management experience leading diverse teams.
  • Prior experience with building systems (HVAC, boilers, refrigeration, electrical/mechanical systems, automation, and life/safety equipment).
  • CCRC or healthcare environment experience strongly preferred.


Education

  • High school diploma required; 2+ years of college or trade school coursework in engineering, facilities management, or environmental services preferred.
  • Bachelor’s degree in Engineering, Facilities Management, or related field strongly preferred.


Key Knowledge & Skills

  • Regulatory & Compliance: Deep understanding of building codes, construction regulations, OSHA/OSHPD, Titles 8, 19, 22 & 24, ADA, and environmental compliance.
  • Technical Proficiency: Ability to read blueprints, technical manuals, and schematics; strong understanding of HVAC, plumbing, electrical, carpentry, and mechanical systems.
  • Safety & Risk Management: Expertise in workplace safety, hazardous materials handling, emergency response, and risk mitigation.
  • Operational Excellence: Skilled in housekeeping, maintenance, landscaping, sanitation, and environmental cleaning standards.
  • Project Management: Strong planning, scheduling, and vendor management experience.
  • Technology Skills: Proficient with Microsoft Office and capable of learning maintenance, inventory, and HR systems.
  • Communication & Leadership: Collaborative, calm under pressure, resident-centered, and able to lead with empathy and professionalism.


Why Work at Sequoia Living?

  • A mission-driven organization devoted to enriching the lives of older adults.
  • An opportunity to lead a critical operations team in an established and respected nonprofit community.
  • A collaborative culture where your expertise directly shapes resident safety, comfort, and quality of life.
  • A role with variety, challenge, and the ability to influence long-term building health and operational excellence.


Ready to Make an Impact?

If you are a proactive leader who finds purpose in maintaining exceptional environments, developing strong teams, and ensuring operational excellence we encourage you to apply. Join a community that values integrity, compassion, and innovation.

Not Specified
Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development
Salary not disclosed
Sonoma, CA 4 days ago

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.


Job Description: Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development


Position Overview: The Research Associate III/ Senior Research Associate in Assay Development and Bioanalytical Development will play a critical role in the development, qualification, and validation of bioanalytical methods to support our RNA editing programs. The successful candidate will work under the guidance of an assay development scientist to develop custom assays for the analysis of samples, including AAVs, cells, and tissues. This role also involves drafting key documents such as Standard Operating Procedures (SOPs) and method development reports.


Key Responsibilities:

  • Method Development, Qualification, and Validation:
  • Support the development, qualification, and validation of bioanalytical methods in accordance with regulatory guidelines.
  • Develop, optimize, and execute robust bioanalytical methods for the characterization, release, and stability testing of Amber's gene therapy.
  • Sample Analysis:
  • Support drug absorption, distribution, metabolism, and excretion studies.
  • Perform analysis of AAVs, cells, and tissues to support various stages of research and development.
  • Lead efforts to streamline and optimize sample storage and processing, as well as establishing and maintaining critical reagent stocks and cell banks.
  • Documentation Reporting:
  • Draft and review key documents such as SOPs, method development, and sample analysis reports.
  • Maintain accurate and detailed records of all experiments and analyses.
  • Collaboration & Communication
  • Collaborate with manufacturing and preclinical teams to support pipeline needs.
  • Communicate and present findings clearly to internal stakeholders.


Qualifications:

  • B.A./B.S. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
  • 3+ years of experience in bioanalytical and assay development in the biotechnology or pharmaceutical industry.
  • Demonstrated strong proficiency in a wide range of molecular biology techniques such as molecular cloning, DNA/RNA extractions, RT-qPCR, ddPCR, and ELISA.
  • Experience with cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
  • Hands-on experience using laboratory automated systems (e.g., liquid handlers, extraction robotics, etc.).
  • Background in RNA-based therapies is highly desirable.
  • Experience writing SOPs and reports supporting IND filings (e.g. development, qualification sample analysis reports, etc.)
  • Knowledge of FDA and ICH guidelines for method development, qualification, and validation.
  • Prior history in compiling and analyzing data and generating reports that are routinely presented to project teams.
  • Ability to work effectively in a collaborative, fast-paced environment.


Preference will be given to those who display:


  • High motivation, with a strong work ethic and dedication to generating impact.
  • Attention to detail, with the ability to extract deep insights from data.
  • Ability to go from ideation to data in an independent fashion.
  • Long-term personal vision with defined career goals.
  • Team-oriented thinking.
  • Demonstrated excellence in small team environments, including a “no task is too small” attitude.


If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.


Please apply directly through LinkedIn.


Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

Not Specified
Associate Director or Director, Nonclinical Development
🏢 Amber Bio
Salary not disclosed
Sonoma, CA 4 days ago

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.


Job Description: Associate Director or Director, Nonclinical Development


Position Overview:

We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.



Key Responsibilities:

  • Study Design & Oversight
  • Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
  • Select, negotiate, and manage CROs and external partners
  • Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
  • Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
  • Strategic Leadership
  • Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
  • Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
  • Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
  • Collaboration & Communication
  • Partner with discovery scientists to inform candidate selection strategy
  • Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
  • Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders



Qualifications:

  • PhD in Pharmacology, Toxicology, Biology, or related discipline
  • At least 5 years in a biotech/pharma environment
  • Experience in drug development for ocular and CNS indications
  • Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
  • Strong understanding of FDA and ICH guidance on gene therapy
  • Proven success in managing CROs and vendors for GLP/non-GLP studies
  • Experience integrating nonclinical data into regulatory submissions
  • Ability to synthesize complex data sets and communicate effectively across functions
  • Ability to travel up to 25% of the time



Preference will be given to those who display:

  • High motivation, with a strong work ethic and dedication to generating impact
  • Attention to detail, with the ability to extract deep insights from data
  • Ability to go from ideation to data in an independent fashion
  • Long-term personal vision with defined career goals
  • Team-oriented thinking
  • Demonstrated excellence in small team environments, including a “no task is too small” attitude


If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.


Please apply directly through LinkedIn.


Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

Not Specified
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