Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

We are seeking a Director of Clinical Supply Chain to lead end-to-end clinical supply execution for a global late-stage clinical trial. This role will have full ownership of clinical supply strategy and execution, from demand forecasting through distribution, for programs involving prefilled syringes (PFS) and autoinjectors. The successful candidate will be comfortable operating within a fast-paced environment and partnering closely with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply for our studies. This is a great opportunity to own a critical late-stage program with real patient impact and to have the ability to shape clinical supply strategy during a pivotal stage of the company’s evolution.

Key Responsibilities 

Clinical Supply Strategy & Execution

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including:
• Device assembly and packaging considerations
• Cold-chain (2–8°C) requirements
• Labeling, blinding, and re-supply strategies
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management

• Manage external partners including:
• Packaging and labeling vendors
• Global depots and regional distribution hubs
• Couriers and specialty logistics providers, as appropriate
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.

Distribution & Regulatory Compliance

• Oversee global distribution across multiple regions, ensuring:
• Country-specific import/export requirements
• QP release and EU clinical supply compliance where applicable
• Ensure inspection-ready documentation and robust supply chain traceability.

Cross-Functional Leadership

• Serve as the clinical supply chain lead on cross-functional study teams.
• Partner closely with:
• Clinical Operations on enrollment and site strategy
• Quality on GMP/GDP compliance and deviations
• Regulatory and CMC on changes impacting supply
• Communicate risks, mitigations, and trade-offs clearly to senior leadership.

Qualifications 

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience
• 10+ years of experience in clinical supply chain / clinical supply operations.
• Direct experience managing Phase 3 clinical trials, including global distribution.
• Hands-on experience with prefilled syringes (PFS) and/or autoinjectors in a clinical trial setting.
• Demonstrated ownership of:
• Forecasting and supply planning
• Packaging, labeling, and distribution
• Vendor and depot management
• Strong understanding of GMP/GDP, ICH-GCP, and global clinical supply requirements.
• Cold-chain biologics experience (2–8°C).
• Experience transitioning programs toward commercial readiness.
• Demonstrated ability to balance strategy and execution.
• An ownership mindset, ability to anticipate risk and solve problems proactively.
• Clear communication skills and the ability to translate supply complexity into actionable decisions.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Associate Director, Quality Control will lead critical Quality Control functions to support Jade’s product pipeline across various stages of development. The Associate Director will manage analytical method life cycle including method development, qualification, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf-life management strategy whileensuring full quality compliance with regulatory requirements and internal quality systems.

Key Responsibilities 

• Work with both internal (Manufacturing, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
• Oversee analytical method development, qualification, transfer and validation activities at and cross CDMOs

• Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
• Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
• Collaborate cross-functionally with Manufacturing, QA, Regulatory, and R&D to support tech transfers and lifecycle management, regulatory filing and interactions etc.
• Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
• Review and approve CDMO generated data, investigations, and documentation
• Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
• Serve as QC subject matter expert during regulatory inspections and audits

Qualifications 

• Master’s or advanced degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience (7+ years of experience with PhD)

• 8+ years of experience in Quality Control management within the biotech or pharmaceutical industry
• A strong quality compliance and collaborative mindset, and ability to thrive in a fast-paced working environment
• Strong knowledge of cGMP, FDA, EMA, and ICH regulations
• Strong experience in analytical method life cycle management including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
• Experience with common analytical techniques such as HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development
• Proven leadership in managing internal QC operations or external CDMOs  
• Excellent communication, organizational, and problem-solving skills

Position Location 

This is a fully remote role with up to 20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.