Jobs in San Mateo
602 positions found — Page 6
QA Program Manager – GCP / GLP / GVP
We are partnered with a well established Medical Device company looking to expand their Quality Assurance team.
They are seeking an experienced QA Program Manager, this individual will support the embedded Quality leadership across clinical, nonclinical, and pharmacovigilance programs from early through late-stage development.
Key Responsibilities
- Lead and conduct GCP, GLP, and GVP audits
- Provide hands-on QA support across study planning, execution, and close-out
- Drive inspection readiness and support global regulatory inspections (FDA, EMA, ICH)
- Lead deviation investigations, root cause analyses, and CAPA implementation
- Oversee and qualify external vendors to ensure ongoing compliance
Profile
- 7+ years’ QA experience in pharma, biotech, or medical device
- Strong background supporting clinical, nonclinical, and PV activities
- Proven audit leadership and regulatory inspection support
- Experience in imaging agents, diagnostics, or combination products preferred
Seeking a west coast P&C Account Executive for a national private equity-M&A practice for a top 5 broker in the world.
The primary role of the Account Executive is responsibility for placement and client management on an assigned book of business, as well as guiding the Service team.
The AE is responsible for a more complex book of business, based on industry specialty, account revenue size and/or coverage complexity, such as loss sensitive programs, large deductibles, captives or shared and layered programs.
Overview
Whistler Partners is partnering with a nationally recognized technology and life sciences law firm seeking a mid-level associate (3+ years) to join its world-class Technology Transactions practice.
This team handles complex, cutting-edge technology transactions for some of the most prominent technology, digital media, and consumer tech companies in the United States and internationally — from early-stage innovators to publicly traded market leaders.
The practice works closely with one of the top-ranked startup, IPO, and M&A corporate platforms in the country, offering associates meaningful exposure to the intellectual property and commercial aspects of transformative deals.
Why this role?
At the Center of Innovation
You’ll advise emerging and established technology companies on mission-critical commercial agreements, licensing arrangements, and strategic transactions involving high-value IP and data assets.
True Deal Adjacency
This practice works hand-in-hand with corporate teams on M&A, IPOs, and other major transactions. You’ll counsel on the intellectual property and commercial components of deals — not just standalone contracts.
Breadth Across Growth Stages
From startup technology companies to public enterprises, you’ll gain exposure across the full company lifecycle.
Platform Strength + Optionality
This is a nationally recognized tech transactions group within a broader firm known for its dominance in startup and life sciences work — a powerful foundation whether your long-term goal is partnership or in-house leadership.
Key Responsibilities
- Draft and negotiate complex commercial and technology agreements
- Advise on software licensing, IP commercialization, SaaS, data rights, and platform agreements
- Support M&A and other corporate transactions on IP and commercial diligence and structuring
- Counsel clients on contract and intellectual property strategy
- Work closely with corporate teams advising startup, growth-stage, and public companies
Ideal Candidate Profile
- 3+ years of substantial law firm experience in technology transactions
- Strong grounding in intellectual property and contract law
- Experience handling complex commercial agreements for technology companies
- Exposure to IP and commercial aspects of M&A or other corporate transactions
- Superior academic credentials
- Excellent drafting, communication, and interpersonal skills
- Barred in the jurisdiction of application or eligible to waive/sit for the next exam
Locations
Boston, New York, Silicon Valley, San Francisco, or Santa Monica.
About Whistler Partners
Matchmakers, Not Headhunters
Whistler Partners is a boutique matchmaking firm focused on counseling the best and the brightest attorneys over the course of their careers. We believe that the right move comes from working closely with talent to curate their long-term career paths. When it comes to career advice, what matters is not the size of the agency but the strength of your individual recruiter.
We readily admit that we are elite and only work with the best – after all, a little elitism is okay when it comes to your career. Employers love us because we are picky about whom we represent, and attorneys love us because we get them their dream jobs.
We are seeking an experienced Monitoring Quality Oversight Manager to support multiple oncology clinical trials for one of our growing biotech client. This role provides strategic and hands-on oversight of CRO monitoring activities to ensure data integrity, regulatory compliance, and high-quality trial execution. The position partners closely with Clinical Operations, CROs, and Quality teams to identify risks, implement best practices, and drive continuous improvement across studies.
Key Responsibilities
- Perform monitoring quality oversight across multiple clinical studies
- Develop and execute monitoring oversight plans and risk mitigation strategies
- Review monitoring plans, reports, and trends; implement corrective actions as needed
- Provide subject matter expertise to internal teams and external partners
- Support SOP development, training initiatives, and inspection readiness
- Present oversight findings and recommendations to leadership
- Track monitoring metrics and follow up on CAPAs
- Bachelor’s degree in life sciences or related field
- 6+ years of biotech/pharma experience, including 3+ years in monitoring oversight
- Oncology clinical trial experience required
- Strong knowledge of GCP, ICH, and regulatory guidelines
- Proven CRO oversight and stakeholder management experience
- Excellent analytical, communication, and organizational skills
- Ability to work independently in a fast-paced, remote environment
- Willingness to travel up to 80%
Estimated Min Rate: $80.00
Estimated Max Rate: $100.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
Client: Medical Device
Details:
- 6-Month contract with high potential of conversion
- 40-Hours per week, on-site in SSF
Requirements:
- 6+ years of experience in the medical device industry with at least 3 years of experience in a management, supervisory or lead role
- Experience in building a production team and overseeing assembly team schedule
- Hands-on experience with assembly, testing, or packaging of electromechanical or disposable medical devices
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
Our client is looking for an IP Litigation Associate with 3 to 5 years of AMLAW 200 experience for their very sophisticated practice group. The firm is looking for those that have backgrounds in Electrical Engineering or Computer Science from top schools for this above market to market salary opportunity in any of their 3 locations: Washington D.C., New York or San Francisco. This is a fantastic opportunity to work with a close-knit group that offers no billable hour requirements and the ability to work on some of the most important intellectual property disputes in recent times. If you or someone you know meet these requirements, please message me today. I would LOVE to chat!
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
Location: Remote
Length: 11 month contract
Compensation: $125-$145/hr
Job Summary
A clinical-stage precision oncology biotechnology company is seeking a Director, Biostatistics to lead statistical strategy and execution across its oncology development programs. The organization focuses on developing targeted therapies for molecularly defined solid tumors, with a pipeline spanning early- through late-phase clinical development.
The Director will serve as the statistical lead across cross-functional teams and play a key role in clinical development planning, study design, regulatory interactions, and submissions. This individual will oversee internal and external biostatistics resources, ensure high-quality and timely deliverables, and represent the biostatistics function internally and externally, including interactions with regulatory agencies and key opinion leaders.
Key Responsibilities
- Provide strategic statistical leadership for oncology clinical programs from Phase 1 through regulatory submission.
- Contribute to Clinical Development Plans, study protocols, and Statistical Analysis Plans (SAPs).
- Oversee design, analysis, and interpretation of clinical trial data, including interim analyses and Clinical Study Reports (CSRs).
- Establish and maintain statistical standards and methodologies across clinical, translational, and pharmacology datasets.
- Manage and mentor biostatistics staff, programmers, consultants, and vendors to ensure high-quality statistical outputs (TFLs, analyses, datasets).
- Review and approve key study documents including protocols, SAPs, CRFs, CSRs, and publications.
- Represent biostatistics in cross-functional discussions and regulatory interactions.
- Translate scientific questions into rigorous statistical approaches and clearly communicate results to diverse stakeholders.
- Ensure compliance with regulatory expectations and stay current with evolving statistical methodologies and industry standards.
- Ph.D. or M.S. in Statistics or related field.
- 12+ years of biostatistics experience in pharmaceutical drug development, including 8+ years in oncology.
- Extensive hands-on experience developing complex protocols and SAPs and performing analyses from early-phase through submission.
- Direct involvement in multiple NDA/BLA submissions with successful oncology approvals.
- Deep expertise in clinical trial design and advanced statistical methodologies, including time-to-event analyses.
- Proven leadership experience in cross-functional environments with strong communication and organizational skills.
Estimated Min Rate: $125.00
Estimated Max Rate: $145.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
About the Company
We are seeking an experienced Epic Cupid and Radiant Credentialed Trainer to design and deliver high-quality training for both inpatient and outpatient clinical teams.
About the Role
The ideal candidate will have 10+ years of hands-on Epic experience, proven classroom training ability (virtual and in-person), and a strong background in cardiology and radiology workflows. This role partners closely with Epic analysts and clinical stakeholders to develop role-based curricula, training materials, and competency assessments to support implementations, upgrades, and ongoing optimization.
Responsibilities
- Creating training plans
- Facilitating classes
- Conducting train-the-trainer sessions
- Documenting training outcomes
- Supporting go-live and post-go-live adoption efforts
Qualifications
- 10+ years of Epic Cupid and Radiant experience
- Proven classroom training experience—both virtual and in-person
- Experience working in an academic medical center (e.g., UCSF, UCLA, UCSD, UCDavis, or other university health systems) and training inpatient and outpatient clinical workflows
- Strong communication and collaboration skills; experience working with Epic analysts and clinical SMEs
- Ability to develop role-based curricula, job aids, and competency assessments
Required Skills
- Epic trainer/credentialed in Cupid and Radiant
- Experience in academic medical center environments or large health systems
- Prior experience supporting go-live and sustainment activities
How to Apply:
Straightforward, easy one-click apply.
EEO Statement:
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color,
creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and
related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and
veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic
information, or any other characteristic protected by applicable federal, state, or local laws and Ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental
coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully
vested after you become eligible, paid time off, sick time, and paid company
holidays.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors
considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge,
skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other
law.
At 450 Aesthetics, we believe exceptional dentistry starts long before a patient sits in the chair. It begins with leadership that creates structure, warmth, and accountability. A practice that runs smoothly because the people within it feel seen, supported, and empowered.
We’re seeking a Practice Manager who thrives at the intersection of operations, leadership, and hospitality. This role is equal parts coach and conductor - ensuring systems hum, culture stays strong, and every patient and team member feels the care and excellence that defines 450!
What You’ll Do
- Lead and support a high-performing team, building an environment of accountability, collaboration, and compassion.
- Oversee daily operations. Scheduling, billing, reporting, patient flow, and system efficiency.
- Act as the cultural anchor for the practice, maintaining alignment with our Core Values and Service Commitments.
- Partner with the doctors to manage HR and team development, including hiring, onboarding, coaching, and performance conversations.
- Ensure financial, compliance, and operational systems are executed consistently and refined proactively.
- Cultivate memorable patient experiences by leading with empathy, clear communication, and hospitality.
- Identify opportunities for growth and improvement - not just in processes, but in people and the patient journey.
Who You Are
- A confident, service-minded leader who balances structure with empathy.
- Skilled in communication and follow-through; comfortable leading feedback and growth conversations.
- Adaptable, detail-oriented, and energized by system-building and accountability.
- A lifelong learner who believes leadership means empowering others.
- Passionate about 450’s Core Values:
We Educate, They Decide • Football, Not Golf • Beautiful Smiles AND Service • Fun But Not Fake • Paint By Numbers • Embrace Change
Surgery Center looking to bring on Administrator! Bonus Incentive Program and Relocation!
Outpatient Surgery Center is accredited by the Accreditation Association for Ambulatory Health Care (AAAHC). The Outpatient Surgery Center is a facility in which physicians have an ownership or investment interest. State-of-the-art, multispecialty facility performs procedures in: Orthopedics, Pain Management and Plastic Surgery. 2 Operating Rooms and 1 Treatment Room
- Responsible for directing, coordinating, and controlling all aspects of the operating functions, processes, and staff of the facility while demonstrating the primary goal of efficiently providing surgical services that exceed customer expectations and improve clinical and financial operations.
Qualifications:
- Ideal candidate for this role will either have Ambulatory Surgery Center (ASC) leadership experience or hospital surgical leadership experience with ASC exposure.
- Bachelor’s degree is strongly preferred.
Job Title : Research Associate ( Associate Researcher )
Location : South San Francisco - 94080
Duration : 06 Months
Job Description :
- Direct, hands-on experience with adeno-associated viral nanoparticles
- Successful experience operating electrophoresis (CE, SDS-PAGE, alkaline gel, etc.), light scattering (DLS, MALS, etc.), UV/Vis spectrophotometry, or other technologies for protein/DNA-based product development.
- Experience operating PCR methods.
- Experience in analytical method development and assay transfer.
Experience operating chromatography methods (HPLC, etc.) and proficient understanding of chromatography software.
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.
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: High-Throughput Screening Research Associate II, III (Biodesigner II, III)
Responsibilities:
- Perform massively parallel reporter assays and high-throughput screens across diverse cellular contexts using cellular and molecular readouts.
- Develop and execute molecular biology workflows such as vector design and cloning, DNA/RNA extraction, RT-PCR, qPCR, and next-generation sequencing.
- Support cell culture activities and experiments in multiple cell lines, at small and large scales.
- Design and execute cell-based assays (AAV/lentiviral transduction, transfection, flow cytometry, immunostaining, and other plate reader assays).
- Engineer and characterize cell-based systems using synthetic biology tools and techniques.
- Conduct and troubleshoot experiments, independently and in collaboration with colleagues, to optimize screening throughput, sensitivity, and specificity.
- Proactively troubleshoot technical issues and recommend potential corrective actions based on personal observations and literature searches.
- Prepare summaries of data and present internally to colleagues and management.
- Draft SOPs, follow protocols, diligently document experimental data in lab notebooks, and organize and maintain electronic work records.
- Author scientific reports and data summaries.
- Collaborate with cross-functional teams to meet project goals, bridging early discovery with high-throughput screens to nominate and optimize candidates for further characterization.
Qualifications:
- Bachelor’s or Master’s degree in Biology, Biochemistry, Chemical Engineering, Biological Engineering, or a related field.
- At least 2 years of industry wet lab experience.
- Mammalian cell culture experience (culturing, transfecting and transducing cells, and DNA/RNA purification from cells).
- Molecular biology expertise (vector design and cloning, qPCR, primer and probe design, DNA/RNA extraction workflows)
- Critical thinker with excellent communication skills who thrives in a multidisciplinary, fast-paced team environment.
- Strong written and verbal communication skills.
Preference will be given to those who display:
- High throughput screening assay development in an industry setting.
- High motivation, with a strong work ethic and dedication to generating impact.
- Attention to detail, with the ability to extract deep insights from data.
- First-principles thinking, and an ability to refine one’s intuition based on additional data.
- Ability to go from ideation to data in an independent fashion.
- Long-term personal vision with defined career goals.
- High EQ with team-oriented thinking.
- Experience with pooled, high-throughput screens using next-generation sequencing-based readouts, and/or preparing screening plasmid libraries from synthesized oligo arrays.
- Experience with CRISPR-Cas systems and/or gene editing and delivery technologies.
- Experience preparing next-generation sequencing libraries (Illumina, PacBio, and/or Nanopore platforms).
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.
Global Compliance Partners is seeking an experienced Material Planner to support one of our biotech clients on a contract basis. This is a dynamic, hands-on role embedded in an active CMC development environment where no two weeks look the same.
Hours: 20-40 hrs/week (variable) Duration: 4 months, with potential for extension Location: Hybrid/Remote. On-site onboarding preferred; local candidates strongly preferred
About the Role
You'll serve as the operational backbone for non-GMP material management, working across CMC, clinical, and translational teams to ensure materials are where they need to be, when they need to be there. This role requires someone who can move fast, think ahead, and communicate clearly across a network of internal teams and external partners.
Responsibilities
- Manage and maintain inventory of non-GMP materials across multiple CDMOs and storage sites
- Coordinate material demand planning across CMC, clinical, and translational groups
- Track and respond to specific material needs in real time
- Coordinate domestic and international shipping in partnership with existing external logistics support
- Maintain accurate inventory records and proactively flag supply risks
- Support day-to-day operational needs across manufacturing and supply chain functions
- Serve as a key point of contact between internal teams and external CDMOs on material-related matters
Qualifications
- Hands-on experience in a CMC development environment (biotech or pharma)
- Direct experience working with CDMOs - this is a must
- Strong cross-functional coordination skills; comfortable working across scientific and operational teams
- Ability to manage multiple priorities in a fast-paced, frequently changing environment
- Experience with multi-site inventory management and international shipping logistics
- Self-directed and organized and capable of owning a workstream independently
Position Summary
Our client is seeking a senior-level Statistical Programming Consultant to support audit and inspection readiness for upcoming EMA and BLA filings. This role will partner closely with the Senior Director of Statistical Programming and serve as a key contributor in preparing for and leading/supporting regulatory inspections.
This is not a traditional hands-on programming role. While a strong statistical programming background is required, this individual would have moved beyond pure study programming and repeatedly supported or led inspection readiness efforts. The primary focus will be inspection readiness, audit support, cross-functional communication, and leadership engagement. The ideal consultant is confident, proactive, and trusted by leadership to represent programming during high-stakes regulatory interactions.
Key Responsibilities
- Lead and support EMA and BLA inspection readiness activities, including preparation, execution, and follow-up
- Act as a key programming subject matter expert during regulatory inspections and audits
- Support and advise the Senior Director of Statistical Programming on inspection strategy and readiness
- Prepare programming teams and leadership for inspection-related questions and interactions
- Collaborate cross-functionally with QA, Regulatory Affairs, Clinical, Biometrics, and other stakeholders
- Review and assess programming documentation, processes, and outputs for inspection readiness
- Respond to inspection questions related to programming, data traceability, and submission standards
- Provide as-needed statistical programming support, review, or troubleshooting (secondary responsibility)
- Communicate clearly and confidently with senior management and regulatory inspectors
Required Qualifications
- 10-15+ years of industry experience and prior experience acting as a primary or key inspection readiness lead
- Extensive experience supporting EMA and/or BLA inspections and audits
- Senior-level statistical programming background (e.g., former Lead / Managing Programmer or equivalent)
- Strong knowledge of CDISC standards (SDTM/ADaM) and submission programming
- Demonstrated experience interfacing with management during inspections or audits
- Proven ability to work cross-functionally beyond biometrics
- Excellent verbal and written communication skills
- Comfortable operating in a consulting/advisory capacity, leading without formal authority
Preferred Qualifications
- Experience supporting both US FDA and EMA inspections
- Bay Area local or able to travel onsite as needed
Company Description
US ENT Partners helps ear, nose, and throat (ENT) practices achieve cost savings by aggregating purchasing volume to negotiate maximum discounts with manufacturers, distributors, and suppliers.
Role Description
This full-time Customer Success Associate role is located in the San Francisco Bay Area with a hybrid work model (3 days a week in office). The Associate will handle tasks such as data collection, analysis, interpretation, and communicate findings to stakeholders. This role will contribute to vendor alignment, performance tracking, and the development of actionable insights that support our member practices and internal strategic initiatives.
Qualifications
- Bachelor’s degree in Business, Healthcare Administration, Finance, Analytics, or related field
- 2–4 years of experience in a healthcare, operations, analytics, or consulting environment
- Strong Excel and data visualization skills (Power BI, Tableau, or similar)
- Familiarity with healthcare supply chain, group purchasing, or provider operations preferred
- Strong attention to detail, project management skills, and ability to meet deadlines
- Excellent written and verbal communication skills
- Self-starter with the ability to thrive in a fast-paced, hybrid team environment
OTE: 80-100k
Why US ENT?
Joining our team means being part of a dynamic organization that values data-driven decision-making and continuous improvement. We offer a collaborative work environment, opportunities for professional growth, and the chance to make a meaningful impact in the healthcare industry.
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.
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.
