Foxx Development Inc Jobs in Usa

12,221 positions found — Page 15

Training Consultant
✦ New
Salary not disclosed
Dallas, Texas 1 day ago

Job Description:

Job Title: Automotive Training and Development Consultant

Duration: 06 Months

Location: Dallas, Tx

This position is responsible for analysis, research, development and delivery of manufacturing processes and technical launch training with on-site support to OEM vehicle assembly plants in the US, Canada and Mexico.

Roles and responsibilities include:

• Provide on-site training and support at each of the OEM vehicle assembly plants

• Instruct and consult plant process and repair personnel to improve their understanding of the vehicle and its highly intricate and interconnected systems and subsystems

• Present and demonstrate efficient and effective methods of diagnosing and correcting vehicle assembly, vehicle electrical systems and sub-system deficiencies

• Conduct root cause analysis to accurately identify the cause(s) of assembly and vehicle deficiencies

• Act as the training liaison between product/manufacturing engineering and general assembly by creating, designing and developing training materials related to vehicle assembly process, electrical harness manufacture, vehicle electrical system architectures and schematics

• Communicate and share lessons learned, developed training materials and information gathered in support of one plant project with remaining plants on a timely basis

• Analyze and identify future training needs for each of the OEM vehicle assembly plants

• Support and participate in plant launch meetings and provide training reports to Raytheon management, the OEM management and OEM launch teams

• Interface with engineering, component suppliers and vendors to validate and develop training materials for the manufacturing process, vehicle and vehicle electrical sub-systems prior to the Start of Regular Production (SORP)

• Research and compile manufacturing processes and technical information to be included in training course materials, such as, but not limited to engineering schematics, work in process service information, engineering documents, engineering math data and manufacturing reports

Required Skills:

• Minimum four years of experience as an automotive instructional designer, training developer, automotive instructor and/or manufacturing instructor

• Demonstrated knowledge of automotive systems from an advanced diagnostics perspective

• Demonstrated knowledge of OEM manufacturing tracking and reporting systems

• Demonstrated knowledge of OEM manufacturing dynamic vehicle testing systems

• Ability to develop professional training materials using pre-launch documents

• Ability to read and interpret a digital multimeter, OEM diagnostic scan tool and other automotive related diagnostic test equipment

• Ability to effectively conduct one-on-one and group presentations Ability to interpret early engineering level electrical schematic diagrams

• Ability to read OEM supplier electrical harness prints

• Strong working knowledge of Microsoft Office

• Extensive travel flexibility. Upward of 75% travel, depending upon launch

• Ability to work independently without supervision

• ASE certifications

• Demonstrated presentation skills delivering process and technical training

• Automotive technical assistance center experience

Required Education:

• Associate's degree or Certificate in Automotive Technology, engineering or other related discipline

• High school diploma with eight years of experience as an automotive instructional designer, training developer, automotive instructor and/or manufacturing instructor may be considered in lieu of an associate's degree

Work Environment:

• Work is performed in both classroom and plant settings. Working in plant areas may involve exposure to various automotive fumes, fluids, noise, smells, sharp edges and bump hazards that require continuous use of personal protective equipment, i.e., safety glasses, gloves, and head protection

• Classroom work may involve standing, sitting, walking, occasional lifting (overhead, waist level) from floor, bending, frequent near vision use for reading and computer use

• Physical Requirements: While performing the duties of this position, the employee is frequently required to sit, stand, bend, kneel, stoop, communicate, reach, and manipulate objects

• Duties may involve moving materials weighing up to 35 pounds on a regular basis such as automotive components and equipment, as well as papers, files, boxes, computers, etc. Less frequent requirements for moving materials weighing over 35 pounds do exist with the assistance of lifting and moving equipment, i.e., hoists and lift tables

• Manual dexterity and coordination are required over 70% of the work period while working in the plant areas as well as operating equipment such as computer keyboard, monitor, projector, calculator, printer, and standard office equipment

internship
Chief Attorney Development Officer
✦ New
Salary not disclosed
Washington, DC 10 hours ago

Chief of Attorney Development & Engagement

Locations: San Francisco | New York | Los Angeles | Washington, DC

Compensation: $375,000–$425,000 base + annual bonus


We are conducting a highly confidential search on behalf of a premier international law firm for a Chief of Attorney Development & Engagement. This is a rare C-suite leadership opportunity for a senior legal talent executive or former practicing attorney with deep experience building and scaling attorney development, engagement, training, mentoring, performance management, and culture initiatives across a large, multi-office law firm platform.


This individual will play a critical role in shaping the attorney experience across a global organization of 700+ lawyers by leading strategy around:


  • Attorney learning, education, and training
  • Leadership development and career pathing
  • Performance management and promotion infrastructure
  • Attorney engagement and opportunity initiatives
  • Mentorship, coaching, and retention strategy
  • Alumni relations and brand-building efforts
  • CLE/MCLE compliance and professional responsibility training
  • Pro bono engagement and strategic alignment


The ideal profile will bring:


  • 10+ years of experience in attorney development, talent strategy, professional development, or legal learning leadership within a sophisticated law firm environment
  • Strong understanding of large law firm practice groups and attorney success models across transactional, litigation, regulatory, and IP practices
  • The credibility and judgment to partner with executive leadership, firm management, and board-level stakeholders
  • A modern, innovative mindset around legal talent, leadership development, culture, and GenAI-enabled learning strategies
  • Exceptional discretion, executive presence, and the ability to lead across offices and constituencies


A JD is strongly preferred, and this role is based in one of the firm’s major U.S. offices with an in-office expectation and some travel. This is an exceptional opportunity to step into a visible, enterprise-wide role at a firm known for strong client service, forward-thinking leadership, and a collaborative cross-disciplinary culture.

Not Specified
Account Development Manager
Salary not disclosed
Birmingham, AL 4 days ago

National Account Development Manager


We are a rapidly expanding aesthetic company that offers its employees a truly entrepreneurial experience. This position provides the ability to work as a practice builder with key national accounts and creatively grow partnerships. The company offers amazing support tools that make the position an exciting business-building opportunity on a daily basis. Join our team of highly motivated executives and experience the thrill of being part of a leader in the medical skincare industry.


The company, Marini SkinSolutions, was founded in 1994 and is a recognized leader and innovator in skincare that is committed to continually expanding and improving the professional skincare market. MSS's two primary focuses are to provide innovative technologies that deliver proven measurable results and an unwavering commitment to the ongoing success of our customers.


We believe the National Account Development Manager position to be crucial for our growth strategy. Our support and focus on this role is our number one priority.


We are looking for candidates who want to make a career in the medical skincare industry and have the desire to be part of a dynamic sales atmosphere. We offer growth opportunities within the national account category, so there will continually be new challenges to strive toward. If you are interested in a career, not just a paycheck, then check this out:


1. Training and Development: To begin, you will be put through a highly interactive training course from your home office by our experienced education team. You will be required to master our state-of-the-art CRM system, which is one of many tools provided for your success.


2. National Account Development: Focus on building and nurturing partnerships with key national accounts. Research and identify additional potential national account partnerships that align with our business objectives to enhance growth.


3. Business Consultation: You will be the primary consultant for your national accounts, managing post-sales support, customer product training, and ongoing relationship management. Your role will involve providing actionable insights to help these accounts effectively grow their business with our products.


4. Sales Strategy: Develop actionable ideas to drive growth for your accounts, ensuring that sell-through of products remains your top priority. Collaborate with accounts to brainstorm innovative strategies for enhancing their sales.


5. Routing and Monthly Cycle Visits: Plan and execute regular routing and monthly cycle visits to maintain strong relationships with your national accounts. Ensure consistent engagement and support while assessing account performance, managing processes, and identifying opportunities for growth.


6. Performance Metrics: You will be accountable to achieve monthly and quarterly targets, with success measured through bonuses and commissions that have no cap.


7. Process Management: Implement and manage processes that facilitate the growth of your accounts, ensuring that all initiatives align with company goals and contribute to overall success.


8. Business Analysis: Analyze your business needs weekly to ensure satisfaction among key accounts, enabling you to proactively address their needs and challenges.


9. Dynamic Presentations: You will need to have the ability to effectively present products and business ideas to engage and educate clients.


10. Travel Opportunities: The position offers the exciting ability to travel outside of your territory, including trade shows and medical conferences that are required to support your growth and the growth of your accounts.


We offer an exceptional compensation and benefits package. The competitive base salary plus a NO-CAP highly attractive commission structure, which is geared towards both base and new business development, is outstanding. In addition to this, we also have an annual performance-based plan. If you like the opportunity to earn more all year long, we have a structure you will find motivating and exciting! We offer a full benefit plan which includes: medical, dental, vision, group life, 401K match, paid holidays, and PTO. We also offer a monthly expense reimbursement which includes a car allowance, mileage reimbursement, as well as normal expenses.


This position is for a National Account Development Manager, and candidates must be willing to travel to meet the needs of our key national accounts. Your strong ability to manage processes and focus on account growth will lead to your success.


Are you ready for a career in the skin care industry? Start here and apply today . An HR representative will reach out to you directly. We look forward to hearing from you and thank you for your interest in Marini SkinSolutions.

Not Specified
Technical Fellow of Research & Business Development Advanced Manufacturing & Additive Technologies
🏢 YBI
Salary not disclosed
Youngstown, OH 3 days ago

Organization: YBI

Location: Youngstown, Ohio 

Employment Type: Full-time

Reports To: Chief Manufacturing Officer


Position Overview

YBI is seeking a highly motivated Technical Fellow of Research and Business Development to support YBI’s advanced manufacturing and additive manufacturing initiatives, with a primary focus on supporting the activities of the Youngstown Innovation Hub for Defense and Aerospace.


This position will report directly to YBI while playing a key role in advancing the Innovation Hub’s mission to accelerate additive and advanced manufacturing technologies for defense, aerospace, and industrial applications. The role bridges applied research, federal program development, regional supply-chain engagement, and the development of shared-use, fee-for-service technical services that support manufacturers across Northeast Ohio and the broader Midwest.


Key Responsibilities

Business Development, Commercialization & Innovation Hub Support

• Identify, pursue, and develop business development opportunities aligned with YBI’s advanced manufacturing strategy and the Youngstown Innovation Hub’s defense and aerospace focus.

• Support commercialization and technology transition efforts that move innovations from TRL/MRL development into pilot and production environments.

• Engage OEMs, tier suppliers, foundries, tooling and mold shops, and additive manufacturing service providers throughout Northeast Ohio and the Midwest.

• Represent YBI in engagements with industry partners, government agencies, academic institutions, and regional economic development organizations.


Shared-Use & Fee-for-Service Program Development

• Lead the design, launch, and expansion of YBI’s internal fee-for-service and shared-use technical services, in coordination with Innovation Hub activities.

• Develop service offerings, engagement models, and pricing strategies for reverse engineering, 3D scanning and metrology, rapid prototyping, additive manufacturing, and mold/tooling design.

• Align service capabilities with regional manufacturing needs, workforce development priorities, and defense supply-chain requirements.

• Support utilization of YBI and Innovation Hub equipment and facilities by industry partners, small businesses, and startups.


Grant Writing & Federal Program Development

• Lead and support competitive proposals for SBIR/STTR, Department of Defense, and manufacturing-focused federal funding programs.

• Integrate YBI capabilities, Innovation Hub assets, and sustainable revenue models into grant proposals and long-term program strategies.

• Coordinate proposal development across YBI staff, technical teams, academic partners, and administrative stakeholders.


Research, Technical & Market Analysis

• Conduct applied research and market analysis related to additive manufacturing, advanced materials, and hybrid manufacturing processes.

• Support applied R&D, demonstration projects, and pilot programs in metal and ceramic additive manufacturing.

• Evaluate manufacturability, scalability, cost, and quality considerations for transitioning technologies into production.

• Prepare technical reports, white papers, and sponsor-facing deliverables.


Required Qualifications

• PhD preferred (Master’s degree with significant relevant experience will be considered).

• Demonstrated experience in federal grant writing, particularly SBIR/STTR programs.

• Strong applied research and technical analysis capabilities.

• Working knowledge of additive manufacturing and 3D printing technologies.

• Excellent written and verbal communication skills.


Preferred / Bonus Qualifications

• Experience working with or supporting programs for the U.S. Department of War

• Experience building or managing shared-use, fee-for-service, or applied research service models.

• Familiarity with Northeast Ohio and Midwest manufacturing supply chains, including metal additive manufacturing, 3D-printed ceramics, castings, foundry operations, mold design, tooling, and hybrid manufacturing.

• Experience supporting technology transition, scale-up, or manufacturing readiness initiatives.


Why Join YBI

• Opportunity to work directly for YBI, a national leader in advanced manufacturing innovation.

• Direct role in supporting the Youngstown Innovation Hub for Defense and Aerospace.

• Access to state-of-the-art additive manufacturing, scanning, and prototyping capabilities.

• Collaborative environment connecting startups, manufacturers, academia, government, and workforce partners.

• Meaningful impact on defense, aerospace, and industrial supply chains in Northeast Ohio and the Midwest.


Not Specified
Director Process Development and Manufacturing, CMC
Salary not disclosed
Durham, NC 3 days ago

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer


About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.


Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

  

Supervisory Responsibilities: 

·      None 

 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

 

 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 

 Salary Range:


$190,000-210,000



The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

 

Not Specified
Vice President of Business Development
Salary not disclosed
Morristown, NJ 3 days ago

Position Overview

The Vice President of Business Development is responsible for driving new business growth and strategic partnerships for the agency. This role leads the identification, pursuit, and acquisition of new pharmaceutical, biotech, and healthcare clients while strengthening the agency’s market presence and revenue pipeline. The VP will report to the CEO and collaborate with executive leadership, strategy, and creative teams to develop compelling solutions that address client needs and support long-term agency growth.


NOTE: Candidates in the TriState Area (NJ/NYC/Local PA) are highly preferred.


Key Responsibilities


Business Growth & Revenue Generation

  • Identify, pursue, and secure new client opportunities across pharmaceutical, biotech, and healthcare sectors
  • Develop and manage a robust pipeline of prospective clients and partnerships
  • Lead RFI/RFP responses and pitch development with cross-functional teams
  • Meet or exceed annual revenue and new business targets

Client Acquisition & Relationship Building

  • Build and maintain relationships with senior marketing and commercial leaders within pharma and life sciences organizations
  • Represent the agency at industry conferences, networking events, and client meetings
  • Develop long-term strategic partnerships that generate sustainable revenue growth

Strategic Leadership

  • Partner with executive leadership to define growth strategy and priority target accounts
  • Provide market intelligence on industry trends, client needs, and competitive positioning
  • Collaborate with strategy, creative, medical, and account teams to shape compelling client solutions

Pitch & Proposal Leadership

  • Lead the development of pitch strategies and storytelling that highlight the agency’s capabilities
  • Coordinate internal teams to produce high-impact presentations and proposals
  • Guide contract negotiations and onboarding of new clients

Market Development

  • Identify emerging opportunities in digital health, biotech launches, patient engagement, and omnichannel marketing
  • Strengthen the agency’s reputation within the healthcare marketing ecosystem


Qualifications

  • 5+ years of business development, sales, or client growth experience in pharmaceutical, biotech, or healthcare marketing/advertising
  • Proven track record of winning and growing multi-million-dollar client relationships
  • Deep understanding of the pharma commercialization and marketing landscape
  • Experience leading agency pitches and RFP processes
  • Strong executive presence and relationship-building skills
  • Excellent presentation, negotiation, and strategic thinking abilities
  • Bachelor’s degree required; MBA or advanced degree preferred


Key Success Metrics

  • Annual new business revenue generated
  • Number and quality of new client relationships established
  • Pitch win rate and pipeline growth
  • Strategic partnerships developed within the pharma ecosystem


We offer a competitive compensation package, health benefits/perks, discretionary annual bonus, 401(k) plan with 50% match, and opportunities for growth.


NPG Health is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Not Specified
Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development
Salary not disclosed
Fremont, 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
Santa Clara, 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
Research Associate, Analytical Development and Quality Control
Salary not disclosed
Woburn, MA 3 days ago

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

 

The Role

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


Key Responsibilities

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


Qualifications

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


At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Not Specified
Associate Scientist, Assay Development (Molecular)
Salary not disclosed
San Diego, CA 3 days ago

Duration: 06 Months contract



Job Description:

Supports molecular assay design and development activities across multiple programs

Conducts feasibility studies and contributes to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance


Responsibilities:

Supports molecular assay design and development activities across multiple programs

Conducts feasibility studies and contributes to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance

Executes experimental plans and generates high-quality data to support assay performance and development milestones

Contributes to analytical validation studies, including LoD, precision, reproducibility, and robustness

Analyzes and interprets molecular data, identifies trends, and communicates results clearly to the team

Supports troubleshooting efforts related to assay chemistry, workflow, and instrumentation


Experience:

2–5 years of experience in molecular assay development or related field Scientist:


Education:

Bachelor’s degree in Molecular Biology, Genetics, Biochemistry, Biomedical Sciences, or related discipline required

Master’s degree preferred Experience Associate Scientist:


About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


Recruiter Details:

Name: Dandu Varshith

Email:

Internal Id: 26-05423

Not Specified
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