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CMC Development Manager

2 weeks ago

Stockholm, Stockholm, Sweden Karo Healthcare Full time 120,000 - 180,000 per year

Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.

Join us at Karo Healthcare on our exciting journey. We're currently looking for a CMC Development Manager for our office in Stockholm, Sweden or Copenhagen, Denmark.

What's in it for you?

At Karo, you'll join a fast-moving, international team where science meets business impact. You'll have the freedom to shape projects from development through launch, working closely with internal and external partners across Europe and beyond. This is a hands-on, visible role with real influence - perfect for someone eager to grow, innovate, and make a tangible mark in an agile healthcare company.

What you'll be doing

As a CMC Development Manager, you'll take full ownership of CMC (Chemistry, Manufacturing, and Controls) activities - from concept to commercialization. You'll act as a key technical leader and project driver within our Pharmaceutical Development & CMC organization.

Your key 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.

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.

Benefits

  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a dynamic, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.