Sequoia Biotech Consulting

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🔥 Regulatory Affairs Consultant, Strategy (Full Time)

Posted 23 days ago

🧭 Full-Time

🔍 Life sciences

🔧 Requirements

6+ years experience in regulatory affairs, including agency interactions, submission and project management and regulatory planning.
Experience in supporting teams in filing of INDs/CTAs and NDAs/BLA/MAAs
Expertise across all phases of drug development, including biologics, pharmaceuticals, oncology, orphan drugs, and pediatric studies.
Industry experience and adept teamwork skills to navigate diverse backgrounds effectively.
Strong research skills to stay current with changing regulations and locate relevant resources.
Knowledge of FDA regulations, international guidelines, and the ability to advise on fast-track analysis, pediatric studies, and emergency inquiries.
Proficiency in Microsoft Office applications, particularly Excel and PowerPoint.
Strong communication skills, with the ability to mentor, educate, and influence a diverse group of stakeholders.
Ability to work in a fast-paced, dynamic environment, managing multiple projects and clients while ensuring regulatory compliance and alignment with business goals.
Experience in supporting and developing strategies and participating in Health Authority interactions.

💡 Responsibilities

Guide clients on decisions, agency meetings, and regulatory filings, with emphasis on clinical development.
Oversee INDs, CTAs, application filings, and approvals for various clients, including significant applications for clinical supplies and trials.
Handle FDA meetings, prepare clients, resolve questions, and develop/execute data driven strategies.
Engage in multiple phases of drug development, from early-stage to post-registration, ensuring client needs are met.
Develop and review regulatory documents, authoring NDA, BLA submissions, and coordinating with medical writing, CMC, quality, nonclinical, and technical teams.
Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines.
Lead meetings with FDA representatives, prepare briefing documents, and assist clients in navigating regulatory requirements.
Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement.
Mentor and train new employees, providing guidance on systems, software, and regulatory processes.
Collaborate across departments and with client teams, ensuring alignment on project goals and regulatory strategies.
Maintain continuous education on regulatory updates and new releases, contributing to team knowledge and industry best practices.

Posted 23 days ago

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🔥 Validation Engineer

Posted about 1 month ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 88000.0 - 110000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in Engineering, regulatory affairs, or a related field.
Minimum of 5-7 years of experience in validation engineering, with expertise in equipment, systems, and process validation.
Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to validation processes.
Demonstrated success in managing multiple projects in parallel.
Excellent communication skills with the ability to work effectively across departments.
Strong project management and leadership abilities.

💡 Responsibilities

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
Maintain and enhance validation quality systems to ensure compliance with regulatory requirements (e.g., FDA, EMA).
Develop and improve standard operating procedures (SOPs), work instructions, and quality documentation related to validation processes.
Lead and implement change management strategies to support product lifecycle changes.
Plan, execute, and oversee validation projects from concept through implementation.
Provide technical expertise and troubleshooting support for validation-related issues.
Collaborate with cross-functional teams to align validation strategies with business objectives.

Project ManagementQuality AssuranceChange Management

Posted about 1 month ago

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🔥 Project Manager

Posted about 1 month ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 106991.88 - 152382.37 USD per year

🔍 Life sciences consulting

🔧 Requirements

An engineering degree (mechanical, electrical, construction).
4-9 years of experience on large, complex engineering projects.
3-5 years of relevant experience within the biotech industry.
Experience acting as owner's representative on large projects.
Experience working on multi-employer sites.
Experience from design through construction into commissioning.
Experience writing commissioning strategy/plans.
Experience supervising start-up and commissioning of equipment.
Experience coordinating equipment purchase and movement.
Experience reviewing construction site safety documents.
Experience using project/construction management software.
Experience designing and commissioning lab and office systems.
Experience writing operational and maintenance SOPs.
Experience closing out large projects and ensuring documentation.

💡 Responsibilities

Act as owner's representative on large, complex construction projects.
Work on multi-employer sites.
Take projects from design through construction and into commissioning.
Write commissioning strategy/plan and protocols for large projects.
Review technical submissions from all team members for system installation.
Answer common construction communications like RFIs and Submittals.
Supervise a large sub-contractor team for start-up and commissioning of equipment.
Coordinate the purchase, receipt, and movement of equipment.
Schedule decommissioning and movement of equipment between facilities.
Review construction site safety documents.
Walk construction sites and document observations.
Use project/construction management software.

LeadershipProject ManagementCompliance

Posted about 1 month ago

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🔥 Facilities Engineer

Posted about 1 month ago

📍 United States, India

💸 88000.0 - 107000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in a related field.
Minimum of 2-6 years of Project/Facilities Engineering experience, preferably in facilities background.
Process Equipment and CAPEX experience required.
GMP cleanroom experience and understanding of facility systems necessary.
Knowledge of regulatory requirements and good manufacturing practices (GMPs).
Strong skills in collaboration, communication, prioritization, and problem-solving.
Detail-oriented, highly motivated team player with good organization and initiative.

💡 Responsibilities

Schedule, coordinate, and oversee outside service providers for building maintenance.
Support verification and maintenance with building and utility systems.
Ensure completion and documentation of maintenance tasks as per policies.
Perform emergency troubleshooting and repair on HVAC and utility systems.
Inspect equipment and utilities to identify potential issues.
Maintain records of inspections and repairs for compliance and audits.
Respond to equipment failures and emergencies according to procedures.
Collaborate with other departments for effective facilities management.
Quickly troubleshoot and resolve operational issues.

Project ManagementDocumentationTroubleshooting

Posted about 1 month ago

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🔥 Director, Business Development

Posted about 1 month ago

📍 United States

🧭 Full-Time

🔍 Life Sciences Consulting

🔧 Requirements

Bachelor’s degree required; Masters/MBA preferred
5+ years managing complex clients in life sciences
Experience in account development and business development success

💡 Responsibilities

Develop and execute strategic territory sales plans
Qualify, sell, and close deals through consultative sales
Lead client engagement strategy and manage sales processes

Business DevelopmentNegotiationComplianceAccount ManagementClient relationship managementSales experienceMarket ResearchStrategic thinking

Posted about 1 month ago

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🔥 Associate Facilities Engineer

Posted about 1 month ago

📍 Greater Boston; San Diego, CA; Boulder, CO; India

💸 65000.0 - 85000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in a related field.
0-2 years of Project/Facilities Engineering experience or related experience.
Preferred facilities background, process equipment experience, CAPEX experience, and GMP cleanroom experience.
Demonstrated understanding of facility systems, utilities, and equipment.
Adherence to safety protocols and familiarity with regulatory requirements and GMPs.
Strong collaboration, communication, prioritization, and problem-solving skills.
Highly motivated and detail-oriented team player.

💡 Responsibilities

Schedule, coordinate, and oversee outside service providers for maintenance tasks.
Support verification and maintenance with PIDs, HVAC, electrical, and process flow diagrams.
Ensure completion and documentation of all maintenance tasks.
Perform and oversee emergency troubleshooting and repairs on various systems.
Conduct routine equipment and utility inspections to identify issues.
Maintain documented records of inspections, maintenance activities, and repairs.
Respond effectively to alarms and emergencies.
Collaborate with departments to meet facility needs.
Quickly troubleshoot and resolve system issues.
Manage time and prioritize tasks effectively.

Troubleshooting

Posted about 1 month ago

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🔥 Sr. Process Engineer

Posted about 1 month ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

🧭 Full-Time

💸 125000.0 - 156000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in Engineering, regulatory affairs, or a related field.
Minimum of 7-11 years of experience in pharmaceutical manufacturing and packaging.
Deep understanding of cGMP, FDA, EMA, and USP guidelines.
Proficiency with quality systems and compliance.
Strong project management and leadership abilities.
Excellent communication skills and detail-oriented.

💡 Responsibilities

Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations.
Develop and improve standard operating procedures (SOPs) and work instructions related to manufacturing and packaging processes.
Lead change management strategies for manufacturing and packaging.
Manage and review equipment change requests to ensure timely and compliant updates.
Collaborate with regulatory, quality, and manufacturing teams for effective execution.
Plan and execute manufacturing and packaging projects from concept to implementation.
Identify project risks and implement mitigation strategies.
Drive continuous improvement initiatives in manufacturing and packaging processes.

Project ManagementCross-functional collaborationProcess improvement

Posted about 1 month ago

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