Director/Senior Director, Drug Product Development and Manufacturing (Biologics)

About Us: 

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025.  For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.  

Job Title: Director/Senior Director, Drug Product Development and Manufacturing (Biologics)      

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.          

Role Overview:

We are seeking an experienced and motivated candidate to manage aseptic drug product development and manufacturing in support of early-to-late-stage manufacturing campaigns. In this role, you will be responsible for drug product process development, technology transfer and manufacturing campaigns at the external CDMO partners.  You are an ideal candidate for this role if you have experience with drug product process development, aseptic unit operations, and relevant fill finish equipment utilized for biologics manufacturing. In this role, you will have the opportunity to foster strong collaboration, communication, and problem solving to meet key program and corporate objectives. This is a highly visible role and a pivotal addition to our growing organization where you will play an integral role in supporting multiple campaigns in support of generating supplies for clinical trials across US, Canada and EU.

Key Responsibilities: 

• Lead liquid drug product process development, technology transfer, and GMP aseptic manufacturing at external CDMO partners
• Serve as an aseptic fill finish subject matter expert and support manufacturing process readiness, sampling plans, and in-process control strategy for drug products in vials and pre-filled syringes
• Liaise with drug product formulation and analytical SMEs to develop robust formulations, processes, methods and unit operations in support of GMP manufacturing of high concentration biologic drug products
• Lead and support gap analysis, equipment and raw material risk assessment, filter validation studies, in-use compatibility analysis, transportation, and E&L assessment in a phase appropriate manner
• Serve as person-in-plant (PIP) during drug product manufacturing campaigns
• Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot release, retests, in-process sampling plans, stability protocols/reports, retains, change controls, deviations, OOS/OOT investigations, CAPAs and campaign reports
• Ensure stakeholders such as analytical, formulation, clinical supply chain, quality and PM teams are aligned with overall drug product timelines
• Facilitate critical cross functional decisions within the CMC team while keeping program level stakeholders informed at regular interval
• Collaborate with drug substance manufacturing and clinical supply chain stakeholders ensuring robust clinical supply forecasts
• Develop road map for late-stage process development, process characterization, and PPQ campaigns
• Assist in the diligence process to select clinical and commercial CDMO vendors
• Track internal and external manufacturing deliverables and adapt to changing priorities keeping corporate CMC objectives at the forefront
• Foster a culture of collaboration, communication, critical thinking, innovation, and continuous improvement
• 20-25% travel in support of diligence and campaign execution at CDMOs

Qualifications: 

• Master’s or a PhD in a scientific discipline with 10-15 years of relevant experience in aseptic drug product development and manufacturing of biologics
• Must have prior experience managing drug product development and GMP manufacturing in vials and pre-filled syringes
• Exposure to supporting or leading device development (pre-filled syringes and auto-injectors) is a plus
• Significant experience developing robust unit operations towards large scale drug product manufacturing campaigns  
• Experience with liquid formulation studies, process development, container closure compatibility studies, device functionality studies and QTPP development
• In-depth knowledge of aseptic regulations required to manage multi country regulatory filings
• Demonstrated track record of successful tech transfers to commercial CDMOs with an eye towards late stage and commercial launch
• Strong scientific skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Must have a creative and strategic attitude with the ability to work in a fast-paced environment
• Strong sense of urgency and ability to deliver in a highly fast paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $205,000 to $275,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

What We Offer:

• A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• Opportunities for professional growth and development.