During the first year, your responsibilities and goals will include:

• Drive pharmaceutical development activities for drug substance, drug product, and clinical trial materials throughout development
• Continuously assess and communicate the manufacturing status for multiple programs across a global CDMO network
• Develop and manage the BLA enabling CMC activities for lead clinical programs
• Manage internal and external interactions with quality and regulatory organizations to ensure the timely resolution of technical issues
• Author regulatory submissions to planning and respond to technical queries received from global health authorities
• Assess CMO and supplier performance to plan while also developing phase appropriate contingency strategies
• Represent CMC operations across internal and external project teams
• Grow partner relationships for co-developed programs and support partnering due diligence efforts for preclinical to clinical assets
• Identify and assess new technologies and contractors to support manufacturing requirements

We’d love to hear from you if you have the following:

• Bachelors degree in biological sciences or related field with minimum of 15 years demonstrated experience in a pharmaceutical setting. Advanced degree is preferred (MS/PhD)
• Hands-on experience with large molecule drug substance and drug product manufacturing processes, as well as clinical packaging and distribution
• Demonstrated a track record of building relationships with vendors, suppliers, and contract organizations effectively
• Ability to deliver in a fast-paced, small company environment and the tenacity to seamlessly adjust workload based upon changing priorities
• Ability to mentor and lead both directly and through influence
• Excellent communication skills, including the ability to influence cross-functionally and articulate complex issues clearly to drive understanding and decision-making
• Experience developing and managing projects and budgets to plan
• Thrive in an environment where work is accomplished both independently and by teams
• Understanding of ICH, FDA, and USP guidelines in phase-appropriate pharmaceutical development
• Outstanding ethics and integrity


Salary Range: