Project Manager - Sacramento, United States - Orca Bio

Description

Over one million people in the world today are fighting blood cancer.

While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects.

The first application of Orca Bios platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

The

Tech Transfer (Senior) Project Manager

will effectively plan, manage, and provide oversight and direction for our technology transfer from our current research and manufacturing site to our new commercial site, both located in Sacramento.

This position will work cross-functionally with CMC, Quality, Facilities, and Manufacturing to set and track progress against timelines and deliverables.

The successful candidate shall be an experienced project manager with technology transfer experience, with a proven track record of operating in a multidisciplinary, collaborative, fast-paced environment.

Based on the performance of the selected candidate and our enduring organizational requirements, there is a potential for this ~6 month contract position to transition into a Full-Time Equivalent (FTE) role.

Qualifications:

Communication :

Persuasively convey ideas and suggestions for forward momentum; skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies; comfortable with negotiation and challenging the status quo and bringing forward innovative solutions.

Knowledge Base:
Prior experience in GMP Quality in the biopharmaceutical

or related

industry; understanding of must-haves vs. nice-to-haves for technology transfers

Organizational:
Strong attention to detail; propensity to document at the right level; able to identify roadblocks and provide direction to teams to explore alternatives

Technical:
Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions; understand and edit SOPs; expert with Microsoft Project (MPP) or Smartsheets

Responsibilities:
Partners with the CMC, Quality, Facilities, and Manufacturing to ensure detailed project plans for tech transfer are established, maintained, and integrated with larger BLA timelines
Partners with the regulatory project manager to ensure alignment
Communicates progress to senior leadership on a bi-weekly to monthly basis
Supports tech transfer lead in planning and directing the seamless execution of goals across involved parties
Ensures an appropriate level of urgency is communicated while maintaining focus on deliverables
Identifies potential critical issues, constraints, bottlenecks, risks, and mitigation management (and proposed solutions to support decision-making) across individual programs
Drives decision making processes and escalate issues, as needed
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right, and to embody our core values of passion, courage, and integrity.

Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate daily on a path that hasnt been paved.

This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission.

It means we arent afraid to ask why not, and encourage lively discourse around rethinking the status quo.

We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.

Were proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.

Our employment activities, inquiries and offers are managed through our HR/Talent department, and all candidates are presented through this channel only.

We do not accept unsolicited resumes.
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