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

Logistics Manager

We are seeking a highly experienced and motivated Logistics Manager to work on a...

Location

United Kingdom , Isle of Skye

Salary:

Not provided

Randstad

Expiration Date

March 21, 2026

Requirements

Bachelor's degree in logistics, supply chain management, or a related field
Proven experience in logistics management, preferably in the pipeline or civil engineering sector
In-depth knowledge of logistics principles, best practices, and regulations
Strong leadership and team management skills, with the ability to motivate and develop a diverse team
Excellent organisational and problem-solving abilities, with a keen attention to detail
Effective communication and interpersonal skills, with the ability to collaborate with multidisciplinary teams and stakeholders
Proficiency in logistics software and systems for inventory management and transportation tracking
Familiarity with health, safety, and environmental regulations in the pipeline industry
Ability to work under pressure and meet tight deadlines

Job Responsibility

Develop and implement logistics strategies and plans for the pipeline project, ensuring efficient and cost-effective operations
Coordinate with project managers, suppliers, and contractors to ensure timely delivery of equipment, materials, and personnel to the project site
Manage the logistics team, including hiring, training, and performance evaluation
Monitor and track inventory levels, ensuring an adequate supply of materials and equipment at all times
Oversee transportation activities, including coordinating with shipping companies, arranging permits, and ensuring compliance with relevant regulations
Implement effective safety and security protocols to protect personnel and assets during transportation and storage
Evaluate and select suppliers and contractors, negotiating contracts and managing vendor relationships
Develop and maintain strong relationships with internal and external stakeholders, including project team members, clients, and government authorities
Monitor project timelines and budgets, identifying and resolving logistics-related issues that may impact project delivery
Conduct regular reporting and analysis of logistics operations, providing recommendations for process improvement and cost reduction

New

Bid Manager

Our large Utilities client is currently hiring for a Bid Manager position. You w...

Location

Ireland , Castlebar

Salary:

Not provided

Randstad

Expiration Date

March 05, 2026

Requirements

7-8 years of experience in a similar role
Experience managing multiple internal and external stakeholders
Understand the procurement processes

Job Responsibility

Responsible for the production, quality and timely delivery of compliant, commercially sound, market-leading, winning bids and proposals
Manage the Client/Supplier experience and relationship
Plan and manage bid teams and inputs from a variety of internal stakeholders

!

New

Property Manager

Location

United Kingdom , St Neots

Salary:

Not provided

Randstad

Expiration Date

March 27, 2026

Requirements

Good understanding of Residential Property Management and current legislation
Well developed interpersonal and oral communications skills
Interpersonal skills and customer focused
Ability to work on own initiative
Good literate and numerical skills
Diplomacy
Ability to prioritise workload and work under pressure
Candidates must be eligible to live and work in the UK

Job Responsibility

Manage portfolio in accordance with RICS Codes of Practice, ARMA rules
Assisting the Senior Property Manager to provide a full professional property management services for a portfolio of freehold/leasehold developments and individual properties on behalf of freehold clients, Developers and Resident Management Companies, proactively manage in relation to managing agent/SLA
Assisting the Senior Property Manager to manage in relation to company targets of income and service delivery
Dealing with leaseholders enquiries appertaining to the development
Handling telephone calls and taking detailed messages/dealing with them in an appropriate manner
Responding to correspondence/emails including those from Directors, lessees and tenants - as requested by the Senior Property Manager or Team Leader
Issue Draft Minutes to Directors
Action Minutes
Write to lessees/tenants/letting agents in relation to any matters which may contravene the terms of the lease, i.e. noise/nuisance, satellite dishes, untaxed vehicles, pets, etc
Contacting the DVLA regarding abandoned cars following procedures

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

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

Similar Jobs for CMC Project Management Specialist

CMC Project Management Specialist

Analytical Specialist - CMC

Drug Substance Senior Specialist – Biologics

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Logistics Manager

Bid Manager

Property Manager

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

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

Similar Jobs for CMC Project Management Specialist

CMC Project Management Specialist

Analytical Specialist - CMC

Drug Substance Senior Specialist – Biologics

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Logistics Manager

Bid Manager

Property Manager

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
February 17, 2026