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CMC Technical Writing Manager

Orca Bio

Orca Bio

IT
Menlo Park, CA, USA
Posted on Wednesday, April 10, 2024
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
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 who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
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 team, and all candidates are presented through this channel only. We do not accept unsolicited resumes.