Pharma IT Careers

Senior CMC Biologics Consultant

Location: Copenhagen, Denmark

Application deadline: ASAP

Pharma IT Careers

Senior CMC Biologics Consultant

Location: Copenhagen, Denmark


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Pharma IT is looking for an experienced CMC Biologics Consultant to support our clients within Pharma, Biotech and Medical Device Industry. Preferably you are skilled within DS manufacturing processes of biologics.

As a Senior CMC Biologics Consultant, you will support our clients with CMC related production development and analytical methods.

In this role, you will work in close collaboration with the customer’s CMC responsible/team. You will be responsible for securing trial deliverables within budget, following the customer’s timeline, and according to quality standards defined by regulations and the costumer’s quality system. As a CMC consultant you will be challenged with a broad range of tasks, enabling you to utilize your expertise in a vast variety of ways.

Key Responsibilities

  • Helping our customers bring their products to market
  • Writing/Reviewing of module 3 of BLA or IND
  • Development tasks within formulation and analytical methods
  • Acting as a QP for costumers
  • Development and maintenance of quality systems
  • Performing audits
  • Working as part of a QA team
  • Oversight of CROs and other vendors involved in the CMC work
  • Contributing to the continuous improvement of customer procedures securing best practices

Your Qualifications and Experience

Successful candidates will demonstrate experience in CMC, be proactive, curious, and prepared for continuous learning. Furthermore, a successful candidate will have:

  • MSc in biological or pharmaceutical science or equivalent
  • 5+ years of experience within biological CMC
  • Experience within DP production development
  • Experience within pharmaceutical- or analytical development
  • Prior experience in writing and reviewing module 3
  • A structured work style with an eye for detail, but also posses the ability to be pragmatic and keep a broad project overview
  • A team player attitude with a consultancy mindset, and the ability to work within ambitious timelines in an organization with an experienced drug development team
  • Results-oriented mentality and commitment to contributing to the overall success of Pharma IT and our customers

About Our Firm 

Pharma IT aims to deliver price-competitive young talent and experienced professional consultants to the pharma, biotech, and medical device industries. Our exclusive focus on these industries and agile, customer-oriented approach ensures we maximize customer value. We assist clients across all key areas of these industries, including: Management & Business Consulting, IT Consulting, Drug Development, Medical Device Consulting, Manufacturing Consulting, Quality, Compliance & Security Consulting.

Our team consists of ~100 diverse and talented consultants, and we are currently experiencing rapid growth. We encourage people of all ages, genders, sexual orientations, nationalities, religions, and ethnic backgrounds, to apply.

If you want to know more about us, feel free to check out our about page.

Benefits

Pharma IT offers industry-leading contracts and work-life balance. We offer a base salary with an accelerated bonus model as part of what we believe is one of the best employment packages in the industry. Our core belief is that employees should set their own hours, do what they are best at, and be able to spend as much time at our customers’ sites as possible.

We encourage applications from people of all ages, genders, nationalities, religions and ethnic backgrounds.

How to Apply

This position will be filled on a rolling basis. Interested applicants are encouraged to reach out via email as soon as possible to Torben Elhauge at toel@pharmait.dk

We look forward to hearing from you!

Pharma IT

Improving the standards of pharma consulting