Salary Range: $120 - 140k 

The Role 

Debut Biotechnology is seeking a Technical Project Manager in our Process & Commercialization Team.  

The Technical Project Manager will lead C(D)MO (Contract [Development] Manufacturing Organization) related projects, including the search of suitable C(D)MOs for our developed fermentation & downstream processes, technology transfer to the selected C(D)MOs, and manufacturing support services to ensure successful production of our products, in-spec and on time. This will include process fit assessments, supply chain management (consumable and equipment procurement), and extensive communication between all stakeholders within the projects (internal & external). The candidate will interface with CMOs as the primary technical contact on behalf of Debut, and guide the internal Debut process development teams towards robust, scalable and successful processes. The candidate will need strong organizational and communication skills, ensuring to always work towards fulfilling the business objectives in an affable and effective way. The successful candidate will work closely and cross-functionally with the members of the fermentation, pilot plant, downstream process development, analytical, quality and brands teams. 

Responsibilities 

• Lead C(D)MO selection and search (either new or existing) for new projects. Coordinate cross-functionally with team members within Process Development teams to evaluate and recommend suitable C(D)MOs. 
• Lead technology transfer to selected C(D)MOs, inclusive of collaborative authorship and dissemination of technology transfer packages (fermentation, downstream & analytical), and ensuring questions/enquiries from C(D)MOs are addressed by relevant Debut representatives. 

• Act as Primary Technical Contact on behalf of Debut for C(D)MO communication, directing relevant communication to suitable Debut representatives. Manage C(D)MO communication throughout technology transfer from concept to launch, and continually through campaigns. 
• Manage & negotiate timelines for C(D)MO production runs. Ensure presence of consumables and equipment at C(D)MOs for successful, on-time production. 
• Coordinate activities with the Brands and Marketing teams, ensuring the timelines for product manufacturing meets business requirements for product launch and continual material supply. 
• Lead recurring project meetings (internally & externally), issuing meeting notes & action items for all projects managed. 
• Use typical project management tools to communicate and issue timelines, goals, roles & responsibilities (e.g. Gantt charts, flow diagrams, swim-lane diagrams) to cross-functional project team to maintain project schedule. Communicate pro-actively about any gaps in planning, and act swiftly to investigate workable solutions.   

• Travel as needed to address the needs of External Manufacturing (domestically & internationally) up to 20% of time, inclusive of weekends. 
• Other duties as assigned. 

 

Qualifications 

Required Qualifications 

• Bachelors degree in Science or Engineering subject. 
• 5+ years of relevant work experience, ideally in biotechnology process development, manufacturing or supply chain. 
• Excellent written and verbal communication skills with great attention to detail. 
• Experience with Microsoft Office Suite, to include: Excel, Word, Outlook, and PowerPoint. 

Preferred Qualifications 

• Proven track record of team leadership and project success. 
• Experience in biomanufacturing technology transfer and C(D)MO management/interfacing strongly desired. 

Other 

• Employment is subject to a criminal background check. 
• Must be willing to work with biohazardous agents (up to BSL2). 

• Work requires sufficient hand, arm, and finger dexterity to operate computer keyboard and office equipment. Laboratory operations require dexterity and care to perform studies as required. 
• The R&D laboratory will result in exposure to hot and cold temperatures, noise, fumes, limited dust, and oily coolants. 
• Requires walking, climbing stairs, bending and occasional lifting of material up to fifty (50) pounds. 
• The performance of this position will present exposure to an industrial environment and requires support and compliance with the published Company PPE policy including but not limited to the use of personal protective equipment such as safety glasses with side shields, appropriate attire, safety shoes, hard hat, hearing protection, etc. 
• Debut Biotech is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. 

Salary Range: $120 - 140k