Director of Analytical Development

Cambridge, MA, United States

The Company

Cellino is building a precision platform that personalizes human cells for all. Stem cell-derived regenerative medicines are poised to cure some of the toughest diseases within this decade, including Parkinson’s, diabetes, and heart disease. Patient-specific cells provide the safest, most effective cures for these indications. Currently, large scale production of stem cell therapies is challenging due to extensive manual handling, high variability, and expensive manufacturing costs. Cellino’s vision is to enable healthier lives worldwide with personalized human cells.

The Role

Cellino is seeking a Director of Analytical Development to join our Bioprocess & Technical Operations Team who will own and drive execution of our analytical development roadmap with the aim of establishing capabilities to test Induced-Pluripotent-Stem-Cell (iPSC) clones at a high level of throughput and quality. This will entail leading a team to develop, implement, and execute analytical test methods to support development of our novel iPSC biomanufacturing platform.

You will be accountable for the establishment of systems that enable efficient method development, specification setting, and method transfer for high throughput implementations, leveraging Cellino’s automation expertise and internal and external analytical expertise and capabilities.

Key responsibilities for this role include developing and qualifying test methods on automated systems; establishing and exercising internal testing capabilities to support iPSC clone production; defining and managing external testing; implementing robust procedures and data management systems; and establishing analytical control strategies. The ideal candidate will be a collaborative technical leader with a strong background in analytical sciences, experience in the testing of human cell & gene therapy products, adeptness in working with automated and electronic systems, the ability to apply regulatory guidelines, a quality control mindset, and a drive to bring iPSC-based therapies to patients.

Responsibilities

Own and drive execution of Cellino’s analytical development roadmap

Hold role of technical leader for analytical development projects, and provide strategic and scientific input across bioprocess development projects

Effectively manage high performing team of analytical scientists to support test method development, automated systems development, internal testing, and external testing

Ensure timely execution of internal and external analytical testing for bioprocess development and iPSC production runs

Identify and implement improvements to test method design, testing triage plans, instrumentation, and operational execution

Design and implement systems to improve analytical testing workflows, including digital workflows, automated systems, and other lab practices

Partner with project management to develop and communicate budgets, project timelines, and risk mitigation strategies

Collaborate and communicate across key interfaces, including with bioprocess development, automation engineering, and bioprocess operations

Ensure harmonization with federal regulations, guidance documents, and Cellino’s overall product testing strategy.

Create an environment of collaboration, scientific excellence, and innovation, and drive quality principles across the Cellino team

Requirements

10+ years of analytical development and/or quality control experience within the biotech industry

PhD, MS, or BS degree in biological sciences, biochemistry, cell biology, or related field

Strong background in analytical method development for the characterization of novel cell & gene therapies

Expertise in analytical control strategies, including method qualification & validation

Strong leadership and team building skills, including experience managing direct reports

Strong oral and written communication skills

Scientific curiosity, desire to innovate, and ability to problem solve

Preferred Skills and Background

Experience in the characterization of pluripotent stem cells, genomic sequencing methodologies, and flow cytometry

Experience with the use of automated systems for sample preparation and testing

Experience with the use of LIMS systems such as Benchling

Experience authoring technical documents to support knowledge management and regulatory filings

It is the policy of Cellino Biotech, Inc. to provide equal employment opportunity for all applicants and employees. The Company does not unlawfully discriminate on the basis of race, religion, creed, color, national origin, ancestry, physical and/or mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, transgender status, pregnancy, marital status, age, sexual orientation, and military or veteran status, or any other basis protected by law. It also prohibits unlawful discrimination and harassment based on the perception that anyone has any of those characteristics, or is associated with a person who has or is perceived as having any of those characteristics.

Cellino does not accept unsolicited resumes from any source other than directly from potential candidates. Any resumes submitted by a staffing agency in the absence of a current executed contract will automatically become Cellino's property and no recruiting fees or other obligations will be owed in the event of a potential hiring.

#J-18808-Ljbffr