CrawlJobs Logo

CMC Project Management Specialist

enveda.com Logo

Enveda

Location Icon

Location:
United States

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

95000.00 - 115000.00 USD / Year

Job Description:

Join Enveda as a CMC Project Management Specialist in a remote capacity and help us transform natural compounds into life-changing medicines. Your expertise in Chemistry, Manufacturing, and Controls (CMC) will be critical in accelerating our mission to advance drug discovery and development.

Job Responsibility:

  • Lead cross-functional planning and execution of CMC development activities across drug substance and drug product
  • Partner with internal and external teams to define and track development strategies, timelines, and deliverables
  • Oversee and monitor external CRO and CDMO activities, including planning, communication, and batch execution timelines
  • Develop and manage detailed CMC project plans, ensuring timely delivery through proactive communication and follow-up

Requirements:

  • B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar degree
  • 1-2+ years of CMC project management experience in biotech or pharma, with exposure to drug substance and drug product development
  • Ability to manage cross-functional projects and communicate technical details clearly
  • Experience working with external CROs and CDMOs

Nice to have:

PMP Certification is a plus

What we offer:
  • 90% Medical, Dental, Vision
  • 401k Match
  • Flexible PTO
  • Adoption Assistance

Additional Information:

Job Posted:
February 13, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for CMC Project Management Specialist

CMC Project Management Specialist

Location
Location
United States
Salary
Salary:
Not provided
enveda.com Logo
Enveda
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience with CMC project management in the biotech or pharma industry, specifically focusing on drug substance and drug product development
  • Experience leading cross-functional teams
  • Flexibility, adaptability, and resourcefulness
  • Willingness to work occasional early morning or late evening meetings to accommodate different time zones
  • Experience managing external CROs and CDMOs
  • Fulltime
Read More
Arrow Right

Senior Product Specialist, Regulatory Affairs

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
theramex.com Logo
Theramex
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Extensive experience with practical European Regulatory Affairs
  • Good understanding of MA lifecycle activities within DCP, MRP and National procedures (Post-authorisation variations, submission strategies, renewals, PSURs/PSUSAs)
  • Knowledge of CTD/eCTD documentation structure and lifecycle management
  • Knowledge of European regulations and related guidance documents for Regulatory submissions, Product Information authoring, CMC documentation, CTD and eCTD authoring
  • Able to perform other Regulatory Affairs activities with team support (e.g., PASS, PAMs, Centralised Procedure submissions)
  • Able to perform accompanying activities such as artwork reviews/approvals and Prescribing Information preparation
  • Good interpersonal skills and effective problem-solving capabilities
  • Proactive, adaptable and comfortable working across multiple projects while maintaining high standards
  • High attention to detail with excellent organisational and time-management skills
  • Excellent written and verbal communication skills in English
Job Responsibility
Job Responsibility
  • Preparation and submission of required regulatory packages for designated products/countries
  • Authoring/updating of key regulatory documentation including CTD components and Product Information
  • Development and implementation of regulatory strategy for required changes
  • Act as the contact within the business for regulatory advice and support related to designated products
  • Provide support and regulatory advice to key internal stakeholders
  • Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
  • Communication with external stakeholders, including regulatory agencies, CMO’s and third party service providers
  • Creation and maintenance of Regulatory Information Management systems and databases records and entries
  • Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance
What we offer
What we offer
  • 25 days holiday + 8 bank holidays
  • Private Health Insurance for employee and family members
  • Pension contribution: 10% company + 5% employee (auto-enrolled from day one)
  • Hybrid Working
  • Cycle to Work Scheme
  • Engaging employee experience to come together as a community: in-office events, shared learning and much more
  • Fulltime
Read More
Arrow Right

Drug Substance Senior Specialist – Biologics

We are seeking a Drug Substance Senior Specialist with strong experience in biol...
Location
Location
Denmark , København og omegn
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field
  • 8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs
  • Proven experience with PPQ and process characterization for antibody drug substances
  • Solid understanding of ICH Q8–Q11 and global validation expectations
  • Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions
  • Experience in early-stage process development and scale-up
  • Strong project management and organizational abilities
  • Excellent communication and technical writing skills for regulatory documentation
  • Collaborative mindset and ability to work effectively with external partners
  • Flexible, proactive, and comfortable operating in a fast-paced biotech environment
Job Responsibility
Job Responsibility
  • Support early-stage antibody programs by applying phase-appropriate development strategies
  • Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches
  • Provide technical input to CDMOs on process design, scale-up, and risk assessments
  • Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs
  • Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights
  • Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations
  • Support implementation of continuous process verification (CPV) and lifecycle validation strategies
  • Oversee technology transfer to external manufacturing partners for commercial readiness
  • Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy
  • Coordinate comparability studies and process optimization activities with CDMOs
  • Fulltime
Read More
Arrow Right

Specialist I/II, Regulatory Affairs

The Regulatory Specialist will participate in the preparation of documentation p...
Location
Location
United States , Cambridge
Salary
Salary:
130000.00 - 160000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum BA/BS degree in a scientific/engineering discipline
  • 6+ years’ experience in the biotech industry
  • 8-10+ years’ experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions
  • Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines
  • with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products
  • Strong experience with CTD format and content regulatory filings
  • Excellent organizational, written/oral communication, and time management skills
  • ability to communicate complex issues in a succinct and logical manner
  • strong listening skills
  • Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
Job Responsibility
Job Responsibility
  • Able to prepare documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies
  • Compiles documentation for submissions to FDA and global regulatory agencies
  • Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape
  • Support the develop regulatory processes and procedures of regulatory submissions
  • Develops and maintains collaborative partnerships with key internal and external stakeholders
  • Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs
  • anticipate and communicate possible regulatory paradigm shifts
  • Fulltime
Read More
Arrow Right
New

Systems Administrator

Robert Half is seeking a Systems Administrator to support a gaming industry clie...
Location
Location
United States , Bellevue
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Hands-on experience supporting Linux and Windows Server environments (2016 and newer)
  • Experience administering macOS environments
  • Strong working knowledge of Microsoft 365 backend administration
  • Experience managing Mimecast, including spam filtering and email security
  • Proven experience with endpoint management tools and processes
  • Solid background in server administration and management
Job Responsibility
Job Responsibility
  • Own endpoint, server, and application patching across Windows, macOS, and Linux environments using Intune, Jamf, and Patch My PC to ensure security, stability, and compliance
  • Lead vulnerability remediation and security-aligned system hardening in partnership with Information Security, including support for Microsoft 365, Exchange, and email security platforms
  • Provide hands-on systems and endpoint administration, serving as an escalation point for complex server and endpoint issues and supporting deployments and lifecycle management
  • Participate in incident response and on-call rotations, troubleshooting outages, patching failures, and security-related events with sound judgment under pressure
  • Drive operational improvements through documentation, runbooks, root cause analysis, and automation to improve reliability and reduce risk
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Fire Consultant

A growing fire safety consultancy based in the Midlands is looking to appoint a ...
Location
Location
United Kingdom , West Midlands
Salary
Salary:
38000.00 - 50000.00 GBP / Year
https://brandonjames.co.uk Logo
Brandon James
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience within fire safety or a related discipline
  • NEBOSH Fire qualification or equivalent
  • Understanding of fire legislation and risk assessment processes
  • Strong interpersonal and organisational skills
  • Membership of IFE (desirable or in progress)
Job Responsibility
Job Responsibility
  • Deliver fire risk assessments
  • Provide fire safety advice
  • Assist in developing fire safety strategies across a diverse range of properties
  • Engage directly with clients ensuring recommendations are clear, proportionate, and compliant
  • Support audits, inspections, and ongoing safety improvements
  • Play a key role in maintaining high standards and supporting the consultancy’s reputation for quality
What we offer
What we offer
  • Travel expenses covered
  • 25 days annual leave + bank holidays
  • Ongoing training and development
  • Pension scheme
  • Fulltime
Read More
Arrow Right
New

Support Engineer (Team Lead)

We’re looking for a hands-on Support Engineer with Team Leader responsibilities ...
Location
Location
New Zealand , Albany, Auckland
Salary
Salary:
80000.00 - 100000.00 USD / Year
virtuoso.tech Logo
Virtuoso
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2+ years in a senior support or team lead role (MSP experience preferred)
  • Strong hands-on technical capability across: Microsoft 365
  • Microsoft Azure (identity & core infrastructure)
  • Networking fundamentals
  • Windows 11 and Apple macOS
  • Comfortable balancing technical delivery with people leadership
Job Responsibility
Job Responsibility
  • Lead, mentor, and develop engineers across technical, customer service, and behavioural capability
  • Act as a senior escalation point, owning and resolving complex technical issues
  • Stay hands-on — actively work tickets, support customers, and assist during peak periods
  • Manage ticket flow and workload distribution to optimise team performance
  • Drive quality through regular ticket, technical, and customer experience reviews
  • Foster a culture of accountability, continuous improvement, and strong customer outcomes
What we offer
What we offer
  • Funded Training & Development – fully paid certifications and technical training days
  • Flexibility – flexible working, strong leave entitlement, and paid parental leave
  • 25 days annual leave + long service leave
  • Quarterly Bonus – based on individual, team, and company performance
  • Subsidised Gym Membership
  • Social Club – regular team events
  • Great Office Environment – modern workspace, snacks, drinks, and downtime areas
  • Fulltime
Read More
Arrow Right
New

Full-Stack Developer

Robert Half is seeking a highly skilled Full-Stack Developer to support a financ...
Location
Location
United States , Bellevue
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of Full-Stack with a focus on back-end development services
  • Strong hands-on experience with PostgreSQL, including schema design, query optimization, and performance tuning
  • Proficiency in Python for backend development, API development, and data processing
  • Experience with AWS cloud services, specifically Step Functions, Lambda, and event-driven workflows
  • Experience with infrastructure-as-code tools such as CloudFormation or Terraform
  • Strong background building and maintaining CI/CD pipelines for production deployments
  • Experience with distributed systems, microservices architecture, and RESTful APIs
  • Ability to work independently, solve complex technical problems, and deliver solutions with minimal oversight
Job Responsibility
Job Responsibility
  • Design, build, and maintain scalable full-stack applications with a strong emphasis on backend services and platform engineering
  • Develop and optimize PostgreSQL database schemas, complex queries, and performance tuning strategies
  • Build and maintain Python-based APIs, backend services, and data processing workflows
  • Develop and support AWS cloud-native solutions, including Step Functions, Lambda, and event-driven architectures
  • Implement and maintain CI/CD pipelines and infrastructure-as-code using CloudFormation or similar tools
  • Partner with product, architecture, and engineering teams to translate business requirements into technical solutions
  • Troubleshoot and resolve complex production issues across application, infrastructure, and database layers
  • Ensure high code quality through testing, code reviews, documentation, and engineering best practices
  • Contribute to system architecture, technical design discussions, and long-term platform roadmap initiatives
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right