Drug Substance CMC Lead

The Drug Substance CMC Lead position will have overall responsibility for the management and delivery of drug substance development activities from late stage phase to market application within the CMC Development organization and provide leadership, management and oversight to the team. The individual will interact with internal stakeholders and external partners to ensure appropriate deliverables according to project timelines and defined budget.

• Responsible for drug substance CMC development activities from late stage to product licensure.
• Resource planning, project timelines and budget.
• Staff management.
• Writing/reviewing and approval of technical protocols and reports.
• Writing/reviewing of CMC sections (module 3) of regulatory submissions and responses to any agency questions.
• Provide input to project feasibility and suggest changes to ensure successful completion of assigned projects.
• Interface with project governance committees (internal and external) as required
• Provide scientific leadership and direction to the CMC Development team in order to advance the company’s platforms as well as the current and future product portfolio.
• Ensure all activities are carried out to company’s global quality and safety standards.

• PhD/Master in Biotechnology or equivalent.
• 15 years plus experience in late stage development and GMP manufacturing of pharmaceutical products.
• Familiarity with regulatory guidance’s pertaining to the Chemistry, Manufacturing and Control of manufacture pharmaceutical products.
• Experience in project management of complex technical projects involving several internal and external stakeholders.
• Experience in working with C(D)MO’s and CLO’s.
• Excellent communication, negotiation and conflict management skills.
• Ability to think strategically, create innovative strategies, drive changes, manage ambiguity and able to anticipate future trends and consequences.
• Ability to work cross-functionally in a matrix environment.
• Excellent leadership skills with the ability to motivate, inspire and manage a team.
• Excellent verbal and written communication skills in English; French, Swedish, German is a plus.

• Excellent understanding of development processes and challenges • Problem solving, creative, flexible with regards to evolving priorities • Organized, detail oriented and structured working style • Deliver results in a complex business network • Foster collaboration and teamwork and engage internal and external expertise as needed • Perceive change as an opportunity for improvement and successfully manage ambiguity In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.