Biotalent Jobs in Usa

Vice President, Regulatory Affairs & Quality

San Francisco Bay Area (Hybrid)

We are partnering with a venture-backed, early-stage medical device company in the San Francisco Bay Area developing a next-generation software-driven surgical platform leveraging AI to transform procedural care.

With strong early momentum and a clear path toward clinical and regulatory milestones, the team is looking to bring on a Vice President of Regulatory Affairs & Quality to build and lead the entire RA/QA function from the ground up.

The Opportunity

This is a true foundational leadership role, reporting directly to the executive team, where you will:

• Own and define the regulatory and quality strategy for a novel AI-enabled medical device platform
• Lead FDA interactions and act as the primary point of contact with the agency
• Drive 510(k) submissions from scratch (including strategy, authoring, and execution)
• Build and scale a fit-for-purpose Quality Management System (QMS) aligned with FDA and ISO 13485
• Partner closely with R&D, Software, Clinical, and Executive leadership to align regulatory pathways with product development
• Prepare the organization for key inflection points including submissions, audits, and early commercialization

What We’re Looking For

• 10–15+ years of experience in Regulatory Affairs / Quality within medical devices
• Proven track record leading 510(k) submissions from concept through clearance
• Strong experience with software-driven / SaMD / AI-enabled technologies
• Deep understanding of FDA regulations, design controls, and QMS implementation
• Prior experience in an early-stage or startup environment (highly preferred)
• Demonstrated ability to operate as a hands-on leader and strategic partner

Why This Role

• Opportunity to own and build the RA/QA function from zero
• Work directly with an experienced leadership team and investors
• Be part of a company tackling a high-impact clinical problem with differentiated technology
• Significant influence on regulatory strategy, product direction, and company trajectory

A confidential, respected life sciences consultancy is seeking a Manager to join its growing Commercial Strategy team in San Francisco. This is a high‑impact role overseeing project delivery, shaping strategic recommendations, and mentoring future leaders.

You will manage multiple commercial strategy engagements, overseeing analytical work, framing client solutions, and ensuring delivery excellence. While the work is primarily commercial, candidates with blended commercial + medical affairs or commercial + market access backgrounds are encouraged to apply.

You Will:

• Lead multiple commercial strategy projects end‑to‑end
• Oversee project teams and guide junior consultants
• Advise biopharma clients on launch strategy, competitive dynamics, pricing considerations, brand strategy, and market insights
• Own client communications, progress updates, and senior‑level presentations
• Contribute to business development and proposal creation
• Support internal capability building and practice growth initiatives

You Bring:

• 5–8+ years’ experience in life sciences consulting, with strong commercial strategy exposure
• Proven ability to lead teams and deliver high-quality strategic work
• Strong communication, project management, and stakeholder engagement skills
• Comfort managing complex workstreams and overseeing execution
• Advanced degree preferred (MBA, MSc, MPH, PhD)

Why This Role?

• Significant ownership and leadership opportunity within a scaling West Coast team
• Direct exposure to senior leadership and key client decision-makers
• High-impact commercial projects with top-tier biopharma clients
• Supportive, entrepreneurial environment with clear upward mobility

A confidential, high‑growth life sciences consultancy is seeking Consultants and Senior Consultants to join its expanding Commercial Strategy team in San Francisco. This is an opportunity to shape critical commercial decisions for leading biopharma clients while developing rapidly in a supportive, high‑calibre environment.

You will contribute to and/or lead workstreams across a variety of commercial strategy projects, supporting market assessments, launch readiness, brand strategy, customer engagement, competitive intelligence, and other core commercial areas. Candidates with complementary medical affairs or market access exposure are welcome, though the role is not solely medical.

You Will:

• Execute commercial strategy projects across therapeutic areas
• Develop insights, build models, and translate findings into actionable recommendations
• Contribute to client meetings, presentations, and workshops
• Support workstream management; Senior Consultants will manage junior team members
• Shape deliverables and ensure high-quality execution
• Contribute to internal knowledge development and commercial capability building

You Bring:

• Experience in life sciences consulting, ideally within commercial strategy
• Strong analytical, structured problem-solving, and communication skills
• Ability to work collaboratively within high-performing teams
• For Senior Consultants: Workstream leadership experience and comfort guiding junior staff
• Advanced degree preferred (MBA, MSc, MPH, PhD)

Why This Role?

• Fast-growing San Francisco team with abundant development opportunities
• Work across diverse, high-impact commercial topics
• Collaborative, low‑ego culture with strong mentorship
• Exposure to senior leadership and accelerated progression

Data Entry Coordinator - 7 month contract - fully onsite in Fountainebleau, Florida.

Our client is looking for a data entry co-ordinator to join their team this week working full onsite in Fountainebleau, Florida for an initial 7 month contract.

• Perform clinical data processing tasks under the direction of the Site Director or another designated manager.
• Complete all sponsor-required training to obtain the necessary access and approval for data entry.
• Accurately enter protocol-specific data into paper or electronic case report forms.
• Monitor and track data entry to ensure completeness for all study subjects, including completed visits and associated forms.

Job Title: Radiochemist I / II

Employment Type: Full-Time

Overview

A growing organization in the medical device space is seeking a Radiochemist I/II to join its Radiochemistry team. This role supports production-scale radiochemistry operations, ensuring safe and efficient manufacturing of isotope products while contributing to process optimization, technical troubleshooting, and regulatory compliance.

Key Responsibilities

• Perform radiochemistry production procedures safely and efficiently in support of isotope manufacturing operations.
• Serve as a technical resource for assigned isotope product lines, helping ensure supply continuity and process performance.
• Execute and optimize complex radiochemical procedures including solution preparation and ion separation techniques.
• Coordinate production schedules for high-activity materials to support internal and external customer orders.
• Perform radioassay procedures using specialized instrumentation such as ion chambers, liquid scintillation counters, beta/gamma counters, alpha counters, HPGe detectors, and analytical balances.
• Maintain accurate inventory records for radioactive and non-radioactive materials.
• Support validation and qualification of new isotope suppliers and raw materials.
• Develop and implement improvements to radiochemical purification processes and controlled procedures.
• Maintain and operate laboratory equipment including calibration, cleaning, and contamination control.
• Collaborate with Health Physics teams to improve shielding, workflow, and radiation handling practices in accordance with ALARA principles.
• Assist with cross-training and competency development within the department.

Qualifications

• BS or MS in Chemistry, Radiochemistry, or Chemical Engineering.
• 2–5 years of relevant laboratory or radiochemistry experience for Radiochemist I.
• 5+ years of relevant experience for Radiochemist II, including the ability to independently solve technical challenges and support team members with complex chemical questions.
• Experience working with pipettes, analytical balances, and radiochemical laboratory equipment.
• Ability to safely operate hot cells, gloveboxes, or fume hoods without contaminating equipment.
• Strong troubleshooting, problem-solving, and critical thinking skills.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office tools.
• Ability to work independently and collaboratively in a team environment.

Additional Details

• Onsite role in the Los Angeles area.
• Occasional travel between nearby facilities may be required.

A confidential, high‑growth life sciences consultancy is aggressively investing in its San Francisco office and is seeking an Associate Principal or Principal to help lead and expand its Commercial Strategy capability. The market offers substantial opportunity for individuals ready to shape client portfolios, lead teams, and drive commercial expansion.

You will take on a senior leadership position, leading large commercial strategy programs, expanding key client relationships, and driving commercial growth. While the work is strategically centered on commercial topics, candidates with blended backgrounds (commercial + medical or commercial + market access) are welcome.

You Will:

• Lead major commercial strategy engagements across launch, pricing considerations, market shaping, forecasting, brand strategy, and commercial excellence
• Develop and grow strategic client relationships
• Drive business development, target account planning, and revenue growth
• Mentor, develop, and oversee multiple consulting teams
• Shape the direction and growth trajectory of the San Francisco office
• Contribute to leadership initiatives, capability-building, and thought leadership

You Bring:

• 8–12+ years’ experience in commercial strategy within life sciences consulting
• Proven track record of revenue generation and strategic account leadership
• Strong executive presence and ability to influence senior stakeholders
• Experience leading multiple teams and delivering complex engagements
• Ability to shape practice direction and contribute to firmwide growth
• Advanced degree preferred (MBA, MSc, MPH, PhD)

Why This Role?

• One of the most strategically important and fastest-growing markets within the organisation
• Pathways up to Principal or Partner for exceptional performers
• High visibility and significant leadership responsibility
• Ability to shape both client strategy and internal growth
• Entrepreneurial, low-ego, high-talent environment

Clinical Research Coordinator II (CRC II)

Location: Desoto, TX

Compensation: Hourly/Salary

Overview

Our client is a growing clinical research site network focused on conducting industry-sponsored clinical trials to support the development of innovative treatments. They are seeking a Clinical Research Coordinator II to independently manage complex or high-enrolling clinical trials and ensure studies are conducted efficiently and in compliance with regulatory and protocol requirements.

This role is ideal for coordinators who have experience managing trials and want to take greater ownership of study execution while working closely with investigators, sponsors, and CRO partners.

Key Responsibilities

• Independently manage one or more complex or high-volume clinical trials.
• Conduct participant visits, eligibility assessments, and study procedures according to protocol.
• Oversee screening, enrollment progress, and study performance metrics.
• Serve as the primary point of contact for sponsors, monitors, and CROs.
• Support study start-up activities including regulatory preparation and site initiation visits.
• Maintain investigational product accountability and ensure proper documentation.
• Oversee data entry, resolve queries, and maintain inspection readiness.
• Train or support junior research staff assisting on assigned studies.

Qualifications

• Bachelor’s degree required.
• Minimum 1 year of clinical research experience, preferably in industry-sponsored trials.
• Experience managing or supporting complex clinical studies.
• Strong organizational and communication skills.

Professional Experience

Senior Manufacturing Support Engineer

Pharmaceutical Manufacturing Operations

Billerica, MA

Manufacturing Equipment Support

• Provide advanced troubleshooting and rapid recovery support for pharmaceutical manufacturing equipment to minimize downtime and maintain production schedules.
• Serve as Subject Matter Expert (SME) for critical equipment including isolators, vial filling lines, lyophilizers, sterilizers, washers, and packaging systems.
• Monitor process operations to ensure compliance with manufacturing specifications and cGMP regulations.

Process Equipment Reliability

• Maintain operational readiness of sterile filling and process equipment supporting continuous manufacturing operations.
• Troubleshoot complex issues involving mechanical, electrical, automation, and process systems.
• Operate production equipment for setup, testing, or manufacturing support as required.

Validation & Compliance Support

• Support validation maintenance programs and equipment re-qualification activities.
• Assist Validation Engineers during FAT, SAT, IQ, OQ, and PQ activities for new or modified equipment.
• Maintain equipment documentation and records to support validated manufacturing operations.

Quality & Regulatory Support

• Support change control, deviations, and CAPA investigations within TrackWise or similar systems.
• Ensure compliance with FDA regulations and current Good Manufacturing Practices (cGMP).
• Assist with maintenance SOP improvements and documentation updates.

Engineering & Process Support

• Support Manufacturing Engineers with retrofit, improvement, and upgrade projects for manufacturing and critical systems.
• Provide mentorship and technical support to peers within engineering and maintenance teams.

Operational Support

• Participate in 24/7 on-call support for critical manufacturing equipment.
• Perform non-routine and off-hours troubleshooting activities when required.
• Ensure safe work practices and adherence to company safety policies.

Technical Skills

Systems & Software

• CMMS Systems
• TrackWise
• MasterControl
• LMS
• Building Automation Systems
• Microsoft Office Suite

Technical Skills

• Mechanical Systems
• Electrical Systems
• Automation Systems
• Equipment Maintenance
• Process Equipment Troubleshooting
• Engineering Drawings & Schematics

Education

Bachelor of Science – Mechanical Engineering (Preferred)

or equivalent engineering experience

Associate Degree – STEM Field (Optional)

High School Diploma or Equivalent

Certifications & Training

• cGMP Training
• HAZMAT Training
• State Boiler License (Preferred / Obtain within 6 months)
• Electrician License (Preferred)
• Technical Certifications (Preferred)

Additional Qualifications

• Knowledge of aseptic manufacturing techniques
• Experience in pharmaceutical plant operations and maintenance environments
• Ability to read and create engineering drawings and schematics
• Proficient in hand tools, power equipment, and production machinery
• Valid Driver’s License

Physical & Work Environment

• Ability to lift up to 70 lbs
• Work in manufacturing, laboratory, and warehouse environments
• Exposure to noise, temperature variations, and controlled radiation levels
• Use of PPE including safety shoes, glasses, and gloves

BioTalent is partnering with a leading life sciences manufacturer to appoint an Associate Director, Lean Deployment, to lead and elevate the organisation’s Continuous Improvement strategy across its New Castle, Delaware operations.

This is a high-impact role responsible for driving a culture of sustainable change by developing, embedding, and championing Lean and Continuous Improvement methodologies. The successful candidate will collaborate closely with site leadership and a global continuous improvement peer network to improve manufacturing and back-office processes while shaping long-term Lean strategy and deployment.

Key Responsibilities

• Partner with site leadership to develop and execute a site-wide Continuous Improvement roadmap within the organisation’s Lean Operating System.
• Lead transformation initiatives across critical operational areas.
• Facilitate Structured Problem Solving and Value Stream Mapping to guide teams through analysis, planning, and implementation.
• Build and enhance tiered visual and daily management systems that enable effective operational oversight.
• Plan and facilitate kaizen events that drive measurable, sustainable improvements.
• Identify and eliminate waste across transactional and manufacturing processes to increase efficiency and reduce cost.
• Deliver both formal and informal training on Lean and CI tools including Daily Management, Problem Solving, 6S, SMED, Kanban, OEE, and line efficiency.
• Coach and develop employees at all levels to expand Lean capability and CI mindsets.
• Challenge existing processes to elevate performance and drive continuous, sustainable improvement.
• Support improvements across other sites or functions as needed.

Qualifications

• 10+ years of progressive experience in a manufacturing environment.
• Bachelor’s degree required; advanced degree preferred.
• Proven ability to engage leaders and shop-floor teams in Lean deployment.
• Demonstrated history of delivering sustainable results through CI initiatives.
• Practical experience in Lean Manufacturing and the deployment of a Lean Operating System.
• Strong knowledge of value stream improvement tools (e.g., SMED, 6S, Visual Management, Daily Management, standard work).
• Lean/Six Sigma Black Belt certification or equivalent preferred.
• Strong leadership presence with the ability to influence at all levels.
• Proficiency in advanced statistical and Six Sigma techniques is an advantage.
• PMP certification or similar project management credentials preferred.
• Skilled in Microsoft Office and Visio.
• Excellent communication, facilitation, coaching, and problem-solving skills.

Reach out to for more information.

BioTalent is partnering with a leading life sciences manufacturer to appoint an Associate Director of Lean Manufacturing to lead the advancement of Lean methodology and operational excellence across the Milford, Massachusetts site.

This role is responsible for cultivating a culture of sustainable improvement by embedding Lean principles, strengthening operational systems, and driving measurable enhancements in manufacturing and business processes. The successful candidate will collaborate closely with senior leadership and global Lean partners to implement strategy, standardize best practices, and elevate performance across the organisation.

Key Responsibilities

• Partner with site leadership to develop and execute a comprehensive Lean Manufacturing strategy aligned with an established Lean Operating System.
• Lead transformation initiatives across critical manufacturing and support areas to enhance safety, quality, delivery, cost efficiency, and productivity.
• Facilitate Structured Problem Solving and Value Stream Mapping sessions, guiding teams through analysis, planning, and implementation of improvements.
• Build, refine, and sustain tiered visual management and daily management systems that strengthen operational oversight and accountability.
• Plan and conduct kaizen events that deliver rapid and sustainable improvements.
• Analyse and streamline manufacturing and transactional processes to identify waste, improve efficiency, and reduce cost.
• Deliver training on Lean methodologies including Daily Management, 6S, SMED, Kanban, Overall Equipment Effectiveness, and standard work.
• Coach and mentor employees at all levels to develop Lean capability and reinforce continuous improvement behaviours.
• Challenge existing processes to elevate performance and ensure long-term sustainability of results.
• Support Lean initiatives at additional sites or functions as required.

Qualifications

• 10+ years of progressive experience within a manufacturing environment.
• Bachelor’s degree required; advanced degree preferred.
• Proven ability to engage leadership and operational teams in Lean deployment.
• Demonstrated track record of achieving sustainable operational improvements.
• Extensive experience with Lean Manufacturing tools and the deployment of a Lean Operating System.
• Strong knowledge of value stream improvement tools (SMED, 6S, visual management, daily management, standard work).
• Lean or Six Sigma Black Belt certification preferred.
• Strong leadership and interpersonal skills with the ability to influence at all organisational levels.
• Experience with advanced statistical tools and Six Sigma methodologies is advantageous.
• PMP certification or similar project management training preferred.
• Proficiency with Microsoft Office and Visio.
• Excellent problem-solving abilities along with strong communication, facilitation, and coaching skills.

Get in touch at to find out more.