CMC Project Management Specialist Job at Enveda

CMC Project Management Specialist

Join Enveda as a CMC Project Management Specialist in a remote capacity and help...

Location

United States

Salary:

95000.00 - 115000.00 USD / Year

Enveda

Expiration Date

Until further notice

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

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

What we offer

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

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

Care Aide

Location

United States , Beaver Falls

Salary:

Not provided

Dewolfe Place

Expiration Date

Until further notice

Requirements

Certified Nurse’s Aid certification preferred
High School diploma/GED
Must be 18 years of age
Previous experience working with seniors preferred
Ability to communicate effectively with Residents, management, and co-workers
Superior customer service skills
Ability to handle multiple priorities
Must demonstrate good judgment, problem-solving, and decision-making skills

Job Responsibility

Maintaining cleanliness of resident’s room and work areas
Helping residents maintain independence, promoting dignity and physical safety of each resident
Participating and assisting residents with activities of daily living (i.e. bathing, dressing, toileting, grooming, ambulation, transferring, eating) as instructed
Engaging residents in life skills and other life enrichment activities

What we offer

Medical, dental, vision, life and disability insurances
Paid time off
Paid holidays
401(k) plan with company match
Employee Assistance Program
Accident insurance policies

New

Angular Frontend Developer

Location

India

Salary:

Not provided

Bridge Soft Solutions

Expiration Date

Until further notice

Requirements

Deep Angular & TypeScript Knowledge: Proven experience in building and scaling complex, enterprise-level single-page applications (SPAs) using Angular (v10+) and TypeScript. Expertise in reactive programming using RxJS, state management (e.g., NgRx, Akita, or services), and the Angular CLI
Expert-Level Web Standards & Performance: Strong command of modern HTML5, CSS3, and SASS/LESS. Extensive experience with optimizing frontend performance, including lazy loading, change detection strategies, bundle size reduction, Lighthouse auditing, and ensuring a blazing-fast First Contentful Paint (FCP)
Authentication & Authorization: Hands-on experience integrating frontend applications with complex Identity and Access Management (IAM) flows like OAuth 2.0 and OpenID Connect (OIDC). Crucial knowledge includes secure token handling (e.g., refresh tokens, token storage), routing protection
Security Best Practices (Frontend Focus): A security-first mindset with experience in preventing common frontend vulnerabilities, specifically Cross-Site Scripting (XSS), Cross-Site Request Forgery (CSRF), and secure API communication. Deep understanding of the Same-Origin Policy and best practices for securely handling user data in the browser
Unit & Component Testing: Proficiency with testing frameworks like Jasmine and Karma for unit testing services and components. Extensive experience with Cypress or Playwright for robust integration and end-to-end (E2E) testing. Familiarity with component-driven development tools (e.g., Storybook) is a plus
UX/UI Integration & Accessibility: Expert-level ability to translate complex design specifications (Figma/Sketch) into pixel-perfect, highly responsive, and accessible user interfaces (WCAG 2.1). Experience with popular component libraries (e.g., Angular Material, PrimeNG) and building reusable, modular design systems
Years of Exp: 5 - 7 Years

Job Responsibility

Architect and build the core user interface and client-side application logic, focusing on performance, maintainability, and security
Design and implement a scalable state management architecture that ensures data consistency and an exceptional, highly responsive user experience
Write critical, high-performance, and maintainable TypeScript code, setting the standard for the entire frontend codebase
Lead a "Frontend Pod" for 3-4 junior to mid-level developers, fostering a collaborative environment centred on quality and best practices
Conduct thorough code reviews to enforce best practices in coding standards, performance, UI/UX consistency, and accessibility
Mentor junior developers on advanced Angular principles, reactive programming patterns with RxJS, and secure frontend development techniques
Break down complex UI/UX features and technical tasks into manageable stories and sub-tasks for the development team

Fulltime

New

Fm4 captain

Looking to futher advance your career? This may be the role for you! We are seek...

Location

Canada

Salary:

Not provided

Mowi Poland

Expiration Date

May 01, 2026

Requirements

Fishing Master Class 4 Certificate is required
Leadership and project management abilities
Respect for the need for safe working practices and animal welfare
Well-developed English verbal and written communication
Good computer and document management knowledge
A positive attitude, willingness to learn and participate in training opportunities
Ability to work safely and effectively in challenging outdoor weather
Flexible approach to working to meet the demands of the job
Physical capability to complete repetitive tasks and handle material up to 25kg
Comfortable working in remote locations, outside, and on the water

Job Responsibility

Safe and efficient operation of the vessel/barge
Safe and efficient management of the vessel/barge and crew
Ensure all equipment and property is maintained at the highest level
Ensure that all laws, government regulations are adhered to
Ensure all environmental regulations certification criteria are met
Onsite leadership role providing assisting with operational planning and leading implementation

What we offer

Matching company paid Pension Plan contributions (DCPP)
Comprehensive Health & Dental Flex Benefits Plan including Life & Disability Insurance
Employee Family Assistance Program including Telemedicine & Digital Pharmacy
Wellness Programs including an Annual Wellness Reimbursement
Potential for Annual Bonus and Employee Stock Options Program
Company provided Gear and PPE
Opportunity to grow with a large global company

Fulltime

CMC Project Management Specialist

Enveda

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Requirements:

Additional Information:

Job Posted:
February 17, 2026

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Additional Information:

Job Posted:February 17, 2026

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