Scientific Consultant - Combination Products & Primary Packaging (Pharma/MedTech)

Emendo Research & Development is expanding, and we are looking for an experienced Scientific Consultant to strengthen our capabilities within combination products, drug-device systems, and primary packaging development.

About Emendo R&D 

Emendo R&D is a specialized life science consultancy supporting pharmaceutical and medical device companies across the entire product lifecycle. We combine scientific knowledge with a systematic approach to accelerate our clients’ development and optimization projects by combining scientific advice and project management. As part of Emendo Consulting Group, Emendo R&D has earned five consecutive Børsen Gazelle awards - a reflection of the pace at which we have grown and the quality of the team behind it.

The Role

As a Scientific Consultant specializing in combination products and primary packaging, you will take on a central role in our team, driving projects across pharmaceutical and medical device development. Your assignments will be shaped by client needs, but could include:

• Development and evaluation of primary packaging systems, including vials, prefilled syringes, cartridges, and blisters - covering material selection, supplier qualification, and container closure integrity (CCI).
• Technical and regulatory support for combination products and drug-device combinations, such as autoinjectors, pen injectors, prefilled syringes, and inhalers.
• Extractables & leachables (E&L) assessments and material compatibility studies.
• Design control support, including compilation and maintenance of Design History Files (DHF)
• Risk management activities per ISO 14971, including risk analysis, risk control measures, and risk management file documentation.
• Usability/human factors engineering per IEC 62366, including use-related risk analysis, formative/summative evaluations, and usability engineering file documentation.
• Preparation of technical documentation and regulatory submissions in compliance with EU MDR, FDA 21 CFR Part 4, and relevant ISO standards.
• Process validation (IQ/OQ/PQ), stability testing, and support for sterile/aseptic manufacturing processes.
• Collaboration with cross-functional teams at client sites (e.g. R&D, QA, regulatory, and manufacturing).

You will work on-site with our clients as well as from our office in Nordhavn, and flexibility regarding workplace geography is expected.

About You

You most likely have a scientific background in pharmacy, pharmaceutical sciences, engineering, chemistry, or a related field, and have at least 3-5 years of relevant industry experience. Experience with combination products is required, and familiarity with primary packaging development is highly valued. In addition, you:

• Have in-depth knowledge of combination product regulations, including EU MDR/IVDR, FDA 21 CFR Part 4, and ISO 11608 (needle-based injection systems) or ISO 11040 (prefilled syringes).
• Are experienced in primary packaging development, including container closure systems, material compatibility, and CCI testing.
• Have a solid understanding of design controls, risk management, and technical documentation in a regulated environment.
• Are familiar with GMP requirements, ICH guidelines, and industry best practices.
• Can work independently, manage multiple priorities, and communicate clearly at all levels of a client organization.
• Thrive in a consulting environment where structure, pragmatism, and a solution-oriented mindset are key.
• Communicate fluently in English (written and spoken); Danish is an advantage.

It is also a plus if you have:

• Experience with usability engineering and human factors studies (IEC 62366).
• Background in sterile/aseptic manufacturing or fill-finish processes.
• Experience supporting regulatory submissions (MAA, 510(k), PMA) or regulatory inspections.
• Project management skills in a regulated or consultancy setting.

What We Offer

We are a high-performance team that takes pride in delivering work our clients remember - and we believe that great results come from people who genuinely enjoy working together. Our core values of AIM HIGH and MEAN IT are not just words; they are incorporated into how we work every day, which means we constantly strive to stay at the forefront of our field through conferences, seminars, and courses.

At the same time, we make room for the people behind the work. We get together socially every month, run together every week, and once a year the whole team goes on a trip - not just to celebrate, but to make sure we know each other as people, not just colleagues. We highly appreciate a social, supportive, and collaborative environment, and we believe that good people deliver good stories.

Application

If you want to continuously develop yourself, drive results, and create good stories together with Emendo Research & Development, please send us a short motivational letter describing you and your background, your CV, academic transcripts, and recommendations.

We will review applications and conduct interviews on a running basis, so please apply as soon as possible but no later than 09-Aug-2026.