CMC Development Manager at Actriv Healthcare

Copenhagen, Denmark

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

MSc or PhD in Pharmaceutics, Chemistry, Chemical Engineering, Biology, or related field
5+ years of experience in pharmaceutical formulation, process development, or CMC project management
Deep understanding of API characteristics, QbD principles, and GMP/ICH standards
Proven ability to lead cross-functional CMC workstreams and manage external partners (CMOs/CDMOs)
Strong experience in global regulatory submissions (EU; US is a plus)
Excellent technical writing, communication, and stakeholder management skills
Experience in lean or virtual pharma models and post-approval lifecycle management preferred
Curious, proactive, and collaborative - able to thrive in an agile, fast-moving international environment

Responsibilities

Lead the end-to-end execution of CMC projects for topical and oral solid dosage forms — from formulation and process design to scale-up and lifecycle management
Translate API properties into formulation and process design criteria
Develop, optimize, and troubleshoot robust formulations and manufacturing processes
Oversee scale-up, validation, and tech transfer activities with CMOs and CDMOs
Author and review CMC documentation including development reports, process descriptions, and validation summaries
Own and ensure scientific integrity of CTD Module 3 content, supporting global submissions and lifecycle variations
Partner with Regulatory Affairs to define submission strategies, timelines, and responses
Drive cross-functional alignment with QA, RA, Supply Chain, and CMOs to ensure timely and compliant CMC delivery
Manage CMC project plans, risk registers, and key milestones for assigned product portfolios

Skills

Key technologies and capabilities for this role

CMC DevelopmentFormulation DevelopmentProcess DesignScale-upValidationTech TransferCMO OversightCDMO ManagementPharmaceutical DevelopmentTopical Dosage FormsOral Solid Dosage FormsAPI PropertiesLifecycle ManagementRegulatory Documentation

Questions & Answers

Common questions about this position

What is the work location and arrangement for this role?

The position is hybrid and based in the office in Copenhagen, Denmark or Stockholm, Sweden.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What are the key requirements and skills needed for this role?

Candidates need an MSc or PhD in Pharmaceutics, Chemistry, Chemical Engineering, Biology, or related field, plus 5+ years in pharmaceutical formulation, process development, or CMC project management. Required skills include deep understanding of API characteristics, QbD principles, and GMP/ICH standards, experience leading cross-functional teams and managing CMOs/CDMOs, and strong technical writing and communication skills.

What is the company culture like at Karo Healthcare?

Karo Healthcare offers a fast-moving, international team environment where science meets business impact, with freedom to shape projects, hands-on roles, and an agile atmosphere focused on growth, innovation, and real influence.

What makes a strong candidate for the CMC Development Manager role?

A strong candidate will have an advanced degree in a relevant field, 5+ years of CMC experience especially with topical and oral dosage forms, proven leadership in cross-functional projects and external partnerships, and expertise in global regulatory submissions.

Actriv Healthcare

Connects healthcare facilities with nursing professionals

About Actriv Healthcare

Actriv Healthcare connects healthcare facilities with nursing professionals through a digital platform designed for healthcare staffing. The platform allows nursing professionals to create their own schedules, select preferred workplaces, and contribute to patient care. Users download the Actriv app, complete their application, upload credentials, and schedule an interview. Once approved, they can choose shifts that fit their availability, clock in and out for work, and receive payment, along with benefits like vacation and sick time. Actriv stands out from competitors by emphasizing flexibility in work schedules and leveraging technology to streamline the staffing process. The company's goal is to enhance patient care by providing healthcare facilities with the staffing solutions they need while offering nursing professionals the flexibility they desire.

Tacoma, WashingtonHeadquarters

2017Year Founded

$243.2KTotal Funding

DEBTCompany Stage

HealthcareIndustries

51-200Employees

Benefits

Professional Development Budget

Risks

Rising competition from similar healthcare staffing platforms threatens market share.

AI-driven staffing solutions may reduce need for traditional platforms like Actriv.

Potential labor law changes could impact Actriv's business model.

Differentiation

Actriv offers a unique platform for flexible nursing work schedules.

The company provides a seamless app experience for healthcare professionals.

Actriv's platform emphasizes matching skilled professionals with patient care needs.

Upsides

Actriv secured $3.9M for expansion in Tacoma, boosting growth potential.

Four-year streak on Inc. 5000 highlights Actriv's rapid growth and success.

Increased demand for flexible work aligns with Actriv's business model.

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