CMC Project Management Specialist Job at Enveda

CMC Project Management Specialist

Location

United States

Salary:

Not provided

Enveda

Expiration Date

Until further notice

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

Analytical Specialist - CMC

Gubra is looking for an experienced Analytical Specialist, to fill a newly estab...

Location

Denmark , Hørsholm

Salary:

Not provided

Life Science Talent

Expiration Date

March 08, 2026

Requirements

PhD degree in chemistry, biochemistry, pharmacy or similar
Minimum of 5 years of relevant experience from biotech or pharma
Extensive experience with the analysis of peptides in early clinical development at CDMOs
Strong collaboration, communication and stakeholder management skills
Thorough understanding of GMP, regulatory requirements and relevant guidelines

Job Responsibility

Overall responsibility for analytical methods development, with focus on RP-HPLC analyses of synthetic peptides, tech transfer and validation at CDMOs
Collaborate with CDMOs (DS, DP, and other testing sites) on all analytical topics, including specifications and stability studies
Drive operational deliverables in alignment with project goals
Ensure compliant documentation for regulatory submissions
Collaborate with internal stakeholders in the Biotech unit to continuously strengthen and optimize the analytical capabilities within our in-house laboratories

Fulltime

!

Drug Substance Senior Specialist – Biologics

We are seeking a Drug Substance Senior Specialist with strong experience in biol...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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

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

Regulatory Affairs Specialist

The Regulatory Affairs Associate responsibilities encompass the support of US FD...

Location

United States , Maryland Heights

Salary:

66560.00 - 76960.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor Degree in scientific discipline required or equivalent work experience
Minimum of 1-2 years of Regulatory experience or related field
Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required
Project leadership or supervisory experience is preferred
Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally
Excellent written and oral communication skills
Use of change controls software system
Strong background using Microsoft Office tools and Adobe Acrobat

Job Responsibility

Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
Assist with CMC regulatory impact regulatory strategy for post-approval changes proposed at the manufacturing site
Preparation information and technical data needed for support of post-approval changes
Author/review updates to marketed product labeling
Maintain regulatory knowledge of current guidelines and regulations
Maintain current regulatory databases and produce various reports as needed
Utilize and support electronic document management system
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Authoring, organization, and preparation of electronic (eCTD) regulatory filings
also includes peer review of filings

Fulltime

Regulatory Affairs Specialist

The Regulatory Affairs Associate responsibilities encompass the support of US FD...

Location

United States , Maryland Heights, Missouri

Salary:

66560.00 - 76960.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor Degree in scientific discipline required or equivalent work experience
Minimum of 1-2 years of Regulatory experience or related field
Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required
Project leadership or supervisory experience is preferred
Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally
Excellent written and oral communication skills
Use of change controls software system
Strong background using Microsoft Office tools and Adobe Acrobat

Job Responsibility

Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
Assist with CMC regulatory impact regulatory strategy for post-approval changes proposed at the manufacturing site
Preparation information and technical data needed for support of post-approval changes
Author/review updates to marketed product labeling
Maintain regulatory knowledge of current guidelines and regulations
Maintain current regulatory databases and produce various reports as needed
Utilize and support electronic document management system
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Authoring, organization, and preparation of electronic (eCTD) regulatory filings
also includes peer review of filings

Fulltime

New

Senior Engineer/Program Manager

Merrick is seeking a Senior Engineer / Program Manager to provide full-time, on-...

Location

United States , Chamblee, Georgia

Salary:

130000.00 - 165000.00 USD / Year

Merrick & Company

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Project Management, or a related field
10+ years experience on design, commissioning, and / or construction management of building systems (HVAC, plumbing, or electrical) on large projects (>$1 M)
Contribute to the leadership, direction, teaching, and mentorship of junior staff
Experience in managing personnel and project engineering
Strong analytical, organizational, and problem-solving skills
Excellent verbal and written communication skills
Proficiency with Microsoft Word, Excel, and MS Project. Procore or similar project management software
Client projects for this position require US citizenship

Job Responsibility

Direct commissioning activities for a biocontainment laboratory, ensuring that all projects are completed on time and within scope
Maintain project schedules, budgets, and quality standards
Develop a thorough understanding of all project documents, including contracts, design drawings, specifications, and schedules
Assist in developing and maintaining the master project schedule
Manage project team of engineers and technical staff
Coordinate commissioning and remediation activities across multiple operational units, including Research, Facilities Operations and Maintenance, Safety, Security, and more
Provide expertise in direct digital control systems, including controls devices, trending, procedures, and sequences of operations
Lead regular on-site coordination and progress meetings with stakeholders
Promote and enforce a safe, healthy, and environmentally responsible work environment
Ensure all contractor start-up, performance, and pretesting are verified prior to final commissioning

What we offer

Employee Owned - all eligible U.S. employees have an Employee Stock Ownership Account
Robust Employee Referral Program
Annual performance and compensation reviews
Professional Training and Development
Employee Recognition Awards
Peer Mentor Program
health insurance, dental and vision coverage, 401(k), and paid time off (PTO)

Fulltime

New

Senior Java Backend Developer

Technical Expertise to Look For: Deep Java & Spring Boot Knowledge: Proven exper...

Location

India

Salary:

Not provided

Bridge Soft Solutions

Expiration Date

Until further notice

Requirements

Deep Java & Spring Boot Knowledge: Proven experience in building and scaling secure, high-performance RESTful APIs and microservices using Java and the Spring Boot framework
Expert-Level Relational Databases (e.g., PostgreSQL, MySQL): Strong data modeling skills, extensive experience with optimizing complex queries, and a deep understanding of database security features
Authentication & Authorization: Hands-on experience implementing complex Identity and Access Management (IAM) concepts such as OAuth 2.0, OpenID Connect (OIDC), SAML, JWT, and role-based access control (RBAC)
Security Best Practices: A security-first mindset with experience in data encryption (at rest and in transit), hashing algorithms (e.g., bcrypt, scrypt), and preventing common vulnerabilities (e.g., SQL injection, XSS, CSRF, insecure deserialization)
Unit & Integration Testing: Proficiency with testing frameworks like JUnit, Mockito, and Spring Test
Caching & Messaging: Experience with caching mechanisms (e.g., Redis, Memcached) and message brokers (e.g., Kafka, RabbitMQ) for building highly performant and scalable systems
5 - 7 Years of experience

Job Responsibility

Architect and build the core backend services, including robust user authentication, session management, and access control logic
Design and optimize relational database schemas, ensuring scalability, high availability, and robust security
Write critical, high-performance, and maintainable Java code, setting the standard for the backend codebase
Lead a "Backend Pod" for 3-4 junior to mid-level developers, fostering a collaborative and productive environment
Conduct thorough code reviews to enforce best practices in coding standards, security, performance, and API design
Mentor junior developers on advanced Java backend development principles, efficient database interactions, and secure API design
Break down complex backend features and tasks into manageable stories and subtasks for the development team

Fulltime

New

Sales Executive

Our client, a boutique custom software development company with an excellent rep...

Location

United States

Salary:

125000.00 USD / Year

80Twenty

Expiration Date

Until further notice

Requirements

8+ years as a top-performing sales rep selling technical solutions and/or managed services
Proven experience in selling to developer and IT-centric buyers
A “hunter” mentality with the ability to drive results, actively pursuing and closing new business opportunities
Ability to speak with an understand an extent of technical language with DevOps, Cloud, Software Development, and IT services
Strong interpersonal communication skills with the ability to engage clients and partners effectively
Ability to work independently with minimal supervision and adapt quickly in a fast-paced environment

Job Responsibility

Work closely with leadership and founding team to align sales efforts with the company’s overall go-to-market strategy and positioning
Prospect into target accounts, build strong relationships with partners, and drive new business through strategic outreach and engagement
Deliver compelling sales presentations and service demonstrations that effectively communicate the value of our custom software and IT solutions
Drive the sales process from start to finish, close new business deals, and deliver on revenue targets
Stay up to date with industry trends and competitor activities to position our solutions effectively and anticipate client needs
Operate with a sense of urgency, work autonomously, and ensure consistent achievement of sales goals
Collaborate with the technical and leadership teams to ensure a seamless experience for clients post-sale

Fulltime

CMC Project Management Specialist

Enveda

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 13, 2026

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CMC Project Management Specialist

Enveda

Location:United States

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:February 13, 2026

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Job Posted:
February 13, 2026