VP Head of CMC

Location Leiden, Netherlands
Discipline: Biotechnology
Job type: Permanent
Contact name: Ramon Sena

Contact email: r.sena@panda-int.com
Job ref: 10745
Published: 13 days ago

We expect our Head of CMC to be/have:  

• Independent thinker with demonstrated ability to take the lead 

• A deliverable oriented mindset, wit strong sense of ownership

• An advanced degree in biochemical engineering, pharmaceutical chemistry, biochemistry, or relevant technical discipline, coupled with 15+ years relevant pharma and/or biotech experience

• Experience in late stage manufacturing, process validation and clinical and commercial supply chain management

• Proven track record in cGMP manufacturing and IND, CTA and NDA/MAA filings; thorough knowledge of relevant FDA and EMEA regulations

• Experience in working with oligonucleotides is a bonus

• Experience in working with orphan products 

• Experience in overseeing outsourced manufacturing models and evaluating make versus buy concepts

• Track record in building working processes and organizational structure in a biotech environment

• Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations.

• Demonstrated ability to mentor and develop strong leaders.

• Able to work, adjust and lead in a fast-paced, highly dynamic environment.  

• Demonstrated ability for innovative and big picture thinking.

 

Skills and competencies that are required for making the difference: 

• Lead by example

• Flexible and resistant to change

• Critical thinking, decision making and problem-solving skills

• Autonomous 

• Analytical and accurate

• Being able to work in a fast pace environment

• Strong line management skills

• Being able to prioritize multiple tasks

• Excellent communication skills

• Pro-active and pragmatic self-starter, with a result-oriented mindset

• A nice person :-)