Associate Director, Commercial Supply Operations

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.  
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together. 

Job Description

The Associate Director, Commercial Supply Operations is responsible for implementation of the commercial supply operations strategy, managing product launch activities, and driving operational execution, and relationship management of downstream CMOs including commercial packager(s).  
 
This is a critical role within Supply Chain and requires expertise in packaging, serialization, artwork management, product launch, and commercial manufacturing/packaging oversight.  This position will collaborate with other members of CMC, Quality Assurance, Regulatory Affairs, and Finance teams to enable launch readiness and ongoing commercial supply.    
 
You will be excellent at stakeholder communication, building effective relationships and be a technical expert within commercial supply operations. Given the breadth of the Bicycle portfolio, and our expanding supply base, you will be excellent at balancing multiple demands and shifting priorities.  You are organized, and excel at developing plans, managing progress, and generating results.   

Key responsibilities:

• Lead launch readiness activity for Bicycle’s first commercial launch and create playbook for future launches  

• Lead contracting and setup of packaging, serialization, 3PL and logistics providers. 

• Manage US artwork process, including expedited turnaround for launch 

• Oversee CMOs and manage operational execution of downstream supply activity in partnership with Planning and Quality 

• Build and maintain strong partnerships and provide effective communications with all internal and external stakeholders.  Lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded 

• Develop launch and tech transfer plans, along with supply partners, to support global launch timelines, operational harmonization, risk mitigation, and timely execution of production activity 

• Designs, implements, and monitors risk mitigation strategies 

• Establishes KPIs, reports, and monitoring tools.  Negotiates business targets with supply partners, and collaborates to effectively manage performance 
   

Qualifications

• Experience of working within a Pharma, Biotech, or Life Sciences industry is a necessity
• Demonstrated experience in a GMP manufacturing environment with hands-on manufacturing experience or CMO oversight responsibility 
• Strong project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation. 
• Significant experience managing contract manufacturing organizations 
• Direct experience in vial drug product commercial packaging and serialization desired 
• Familiarity with manufacturing and supply chain contracts a significant advantage  
• Ability and willingness to travel domestically and internationally required, up to 25%  

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus 
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company 
• Health and Dependent Care Flexible Spending Accounts 
• 401(k) plan with a 4% Company match and immediate vesting 
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days 
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays 
• Competitive Family Leave Policy 
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more inn