Lead, CMC Analytical Development

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 a late-stage biotechnology company 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.

The Analytical Development Lead (Director/Sr. Director level) is responsible for the AD activities for testing methods for in-process and final release product characterization of early and late-stage cell therapy programs. Additional responsibilities include analytical testing activities to support Process Development, Validations and Comparability studies to be executed at our development labs (Menlo Park) and commercial manufacturing site (Sacramento). You will work closely with other CMC functions and cross-functionally with Quality and Manufacturing Operations, and will travel occasionally to the Sacramento site.

The ideal candidate will have strong late-stage and FDA submissions preparation experience as the Analytical Development lead for biological products. Flow Cytometry and cell therapy expertise would be a plus.

Responsibilities:

● Evaluate and refine analytical approach for cell therapy production at Orca with a goal to enable BLA submission and commercial launch preparation

● Lead activities to drive specifications, method development and validations as needed

● Manage and mentor career development of analytical development group members; manage resourcing of projects and project assignments of group members

● Manage analytical needs for extended characterization of product, characterization of biological activity, analytical comparability studies, forced degradation and stability studies and risk management of critical quality attributes

● Define analytical testing strategies of raw materials, biological starting materials, in-process samples, impurity quantitation, and drug product release and stability, including selection and development of fit-for-purpose methods

● Develop and optimize immunoassays and cell-based functional assays for cell therapy products

● Interpret experimental results and perform data analysis using appropriate software

● Collaborate with and provide training and guidance to analytical development group members in defining, executing and analyzing development studies

● Prepare and present high-quality data summaries and project progress updates to stakeholders and at cross-functional team meetings

● Author and review protocols, technical reports, method SOPs and/or work instructions

● Keep track of scientific literature relevant to assigned assay development projects

● Collaborate effectively with cross-functional teams including Process Development, Manufacturing, QC and Quality Assurance

Qualifications:

● PhD in Pharmaceutical Sciences, Biology, Immunology, or Cell Biology preferred, with 10+ years' relevant industry experience. Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in analytical development and drug product process development

● Experience in immune functional assays in cell therapy and/or biologics analytical development and/or QC laboratories

● Expertise with flow cytometry and cell-based assay technologies

● History with commercialization projects, preparing FDA submissions and successful track record of BLA projects is desired

● Knowledge and broad understanding of QC and cGMP requirements. Good understanding of relevant USP methodologies and ICH guidelines

● Experience in cGMP cell therapy and/or biological product manufacturing, preferably with emphasis on immunological systems, cell/gene therapy, and individualized patient therapies is desired

● Experience working with and leading cross functional teams such as CMC and clinical development

● Outstanding written and verbal communication skills, self-starter with great interpersonal skills and strong planning/tracking skills

● Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation

The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.

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.

To learn more: https://orcabio.com/join-our-team/

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, and we rarely outsource recruitment.