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

Store Delivery Driver

This is a Delivery Driver opportunity that truly delivers on being a NAPA brand ...

Location

United States , Williamsville

Salary:

16.00 USD / Hour

Alliance Automotive UK LV Ltd

Expiration Date

Until further notice

Requirements

Agility to bend to floor-level shelves and reach to upper shelves (eight feet) with use of stool or ladder when necessary
Stamina to stand and walk for entire work shift
Lift up to 60 lbs of merchandise
Able to handle cash charge transactions correctly and core/part returns appropriately
Maintaining a distribution log or tracking system to record all deliveries/pickups made
Inspecting, protecting and maintaining company assets, merchandise, vehicles, building and people
Clear speaking and attentive listening skills
Driving throughout the metropolitan area using maps and directions
Able to be flexible with your schedule including evenings, weekends and holidays
Valid Driver’s License

Job Responsibility

Delivering parts to our Customers with a passion for developing relationships with our customers
Picks up parts from vendors, ensure stock room parts are accurately stocked and maintain/check inventory
Consistently focused on safety while driving and delivering our parts
Serving as a NAPA Brand Ambassador as you meet customers during your deliveries
Building long-term relationships with the customers you deliver to
Maintain store delivery truck through adherence maintained to safety checklists, ensuring vehicle is clean, and that basic maintenance is done (e.g., correct tire pressure)
Other duties as needed

What we offer

Health Insurance: Comprehensive medical, dental, and vision plans
Retirement Plan: 401(k) with company match
Paid Time Off: Vacation, personal days, holidays, sick days, and paternal leave
Additional Perks: Employee stock purchase plan, tuition reimbursement, professional development opportunities, and wellness programs

Fulltime

New

Kitchen Supervisor

Kitchen CDP – Zero hrs contract Mainly Overnight Shifts (8:30pm - 7:30am) with S...

Location

United Kingdom , London

Salary:

35000.00 GBP / Year ▼

The Clockspire

Expiration Date

Until further notice

Requirements

Have a contagious passion for food and/or customer service
Basic knowledge of working in a kitchen environment
Ability to adapt to challenges and opportunities with a solution-oriented perspective
Some knowledge of food safety and sanitation practices
Works according to the BaxterStorey core values

Job Responsibility

Service - cook a night offer of food and prepare breakfast, serve guests in a friendly and professional manner. Ensure that guests’ needs and requests are efficiently and effectively addressed
Customer Service - provide excellent service by being attentive to guests’ needs at every point on their customer journey. Answering questions and addressing any concerns or issues in a friendly manner
Teamwork - collaborate with all colleagues to ensure the smooth flow of operations and support and contribute to creating an inclusive and safe working environment
Adherence to Regulations - comply with health and safety regulations, as well as any specific food service or catering guidelines established on location
Cleanliness - maintain cleanliness and hygiene standards in the kitchen and dining areas

What we offer

28 Days holiday including bank holidays
Plus your birthday off
3 volunteering days
3 days grandparent leave
24 week’s enhanced maternity leave
Secondary career leave
Wedding/commitment day leave
Free meals on shift
Bespoke training and development opportunities
Apprenticeships opportunities for all experience levels

Fulltime

New

Electronics Engineer ADAS

Are you a passionate and experienced Electronics Engineer with a focus on ADAS s...

Location

Netherlands , Eindhoven

Salary:

6500.00 EUR / Month

Randstad

Expiration Date

March 13, 2026

Requirements

Bachelor or Master's degree in Electrical Engineering, Mechatronic Engineering, Automotive Engineering, or a similar field
2+ years of working experience with electric/electronic/mechatronic vehicle systems, particularly those related to ADAS
Proactive and results-oriented team player

Job Responsibility

Lead the development of electric and electronic vehicle systems related to ADAS as Control System Owner
Act as a key integrator between suppliers and our clients' internal departments, driving the development of hardware and software for the VEE Systems
Specify detailed requirements for one or more vehicle systems
Report status and progress on the development process to management on a regular basis

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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Contract Type:
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Job Posted:
February 13, 2026