CMC Technical Writing Manager

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 Bio’s 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.

Summary:

Reporting into the Head of CMC, the CMC Technical Writing Manager will be responsible for CMC document writing, authoring, review and compiling of CMC reports and the CMC sections for regulatory filings. This position will work closely with the cross-functional teams within CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.

Responsibilities:

· Author and/or review technical reports as required by CMC staff.

· Author, compile, and manage CMC sections of a wide variety of regulatory submissions including, but not limited to, CMC Amendments to FDA filings, briefing book meeting packages and BLA submissions.

· Effectively manage the integrated drafting and reviewing process to meet appropriate timelines.

· Ensure that technical reports adhere to appropriate regulatory guidelines.

· Work closely with cross-functional teams to gather input and feedback for report content and formatting.

· Organize and maintain document storage to ensure easy access to reports and related documentation.

Required Qualifications:

· Minimum of Bachelor's degree in Chemical, and/or, Biological Sciences/relevant discipline.

· 3+ years' experience in CMC regulatory filings.

· Strong working knowledge of full CMC spectrum, including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general.

· Prior experience in the preparation of CMC sections of regulatory dossiers in eCTD format.

· Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure.

· Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities.

· Excellent verbal/written communication skills; detail/accuracy oriented.

· Proven planning and organizational skills and regulatory writing skills.

· Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.

Preferred Qualifications:

· M.S. or Ph.D. in Chemical, and/or, Biological Sciences/relevant discipline.

· CMC experience with cell-based therapies.

· Prior BLA filing experience.

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 hasn’t 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 aren’t 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.

We’re 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.