CMC Program Manager

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: CMC Program Manager

Location: Hybrid - Waltham, MA

Role Overview:

We are seeking a highly motivated Program Manager to join our dynamic, growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal in managing and executing strategies for our CMC development projects, driving the success of our early-stage and clinical development programs.

The ideal candidate will have a technical background and bring experience in CMC project management and operations. This individual has the ability to work collaboratively to lead cross-functional teams, plan, track, and streamline a variety of activities, including project strategy and execution, contract negotiation, and vendor management. This individual must be a highly organized self-starter with a solid understanding of both general PM principles in addition to CMC project planning, budgeting, and the integration of activities and vendors necessary for efficient operations. A track record of driving fast paced projects enabling active risk mitigation strategies is important. This position reports to the Director of Program Management.

Our team values in-person collaboration, and we expect this role to work from our Waltham office three days per week. We're looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.

Key Responsibilities:

• Work closely with CMC functions to support the entire portfolio of CMC activities, including all development and manufacturing efforts from preclinical through clinical and commercial phases
• Develop tactical project plans for all CMC activities, leveraging best practices within the PM function to oversee day-to-day operations for Oruka CMC projects.
• Provide project management support for CMC activities related to INDs and other regulatory submissions and ensure smooth advancement of clinical manufacturing programs.
• Coordinate and manage external vendors including interfacing with CDMO Project Managers. Ensure projects are on track with planned timelines and budgets.
• Collaborate closely with the Program Management Team, serving as the CMC program manager.
• Partner with CMC Team Leads to organize and drive team meetings, develop agendas, capture meeting minutes, and track and follow up on action items.
• Build and maintain project timelines and dashboards, tracking CMC activities and deliverables against strategic objectives.
• Partner with the Finance team to help develop annual CMC budgets, long-range plans, and monitor spending.
• Coordinate with the Legal team to track and manage CMC-related contracts.
• Manage strategic alliances and relationships with CMO and CRO partners for CMC-related collaborations.
• Facilitate interactions with consultants and external partners for CMC projects.
• Support the team with documentation and submission-related activities for CMC deliverables.

Minimum Qualifications:

Experience: 5+ years work experience with at least 2 years in a similar project management role required, preferably within a CMC or manufacturing function in the pharmaceutical or biotech industry.

Education: BS in a scientific or technical field; advanced degrees (PhD, MBA, MS) preferred

Skills:

• Strategic mindset with a proven track record in developing and executing impactful project plans.
• Strong understanding of the technical aspects of CMC projects, combined with a focus on flawless execution
• Strong competency using PM tools like Smartsheet, MSP or others
• Excellent verbal and written communication skills, with the ability to effectively present project updates to diverse audiences
• Effective in a diverse, multi-functional team environment with strong interpersonal skills

Attributes:

• Self-motivated, action-oriented, and highly organized. Must feel comfortable working independently
• Collaborative, team-focused, and skilled at working across various disciplines within and outside the company

Preferred Experience:

• Prior experience in small pre-revenue companies
• Demonstrated ability to manage multiple projects simultaneously

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 $135,000-$150,000. 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.

Job Location:

• Position is hybrid, based in Waltham, MA. Candidates will be required to be in-office in Waltham 3 days/week.

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.

Salary Range for the Role

$135,000-$150,000 USD

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.