Position Summary:

Shoreline Biosciences, Inc. (Shoreline) is a biotechnology company developing intelligently designed, allogeneic off-the-shelf, targeted cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer and other serious diseases. Shoreline is seeking an experienced and highly motivated Scientist to join the Analytical Development team. The incumbent will develop product characterization and release assays for our iPSC-derived NK and Macrophage cell therapy portfolios. The candidate will lead assay optimization, standardization, and transfer to internal or external QC labs. The role also includes careful documentation of methods, materials, writing SOPs/reports and communicating findings. In this exciting opportunity, you will be closely collaborating with stakeholders from R&D, Process Development, MSAT, and internal and external QC/Manufacturing environments. This will be a full-time position reporting directly to the Senior Scientist, Analytical Development. The anticipated salary range for this position is $70,000 to $126,000. The final salary offered to a successful candidate is dependent on the candidate's experience, qualifications, geographic location, and other job-related factors. In addition to base salary, the hired candidate is eligible to receive an annual bonus and will receive an equity grant, at the time of hire, in the form of the option to purchase stock in the future for a specified price.

Responsibilities:

• Develop or adapt analytical methods for cell product release and characterization by designing and executing studies via design of experiment (DoE).
• Design and execute exploratory experiments to understand and define CQAs and optimize current analytical methods.
• With minimum supervision, will research, plan, and execute experiments and analyze data to determine the next course of action and make recommendations to internal and inter-departmental audiences.
• Execute routine laboratory experiments in collaboration with more junior technical staff to generate high-quality data by following best practices of assay and instrument operations.
• Perform data analysis and document study outcomes and conclusions, summarize and present to key stakeholders.
• Execute method development studies in support of Process Development/MSAT, product characterization, product release, and stability.
• Participate in authoring assay development and qualification reports and regulatory documents.
• Work with a cross-functional team to advance the development of cell therapy products.

Management Responsibilities:

• Manage, mentor, or train analytical associates or other team members, as needed.

Qualifications:

• Education & Experience
  • Ph.D. degree with 2+ years in a relevant scientific discipline (e.g. Immunology, Cell or Molecular Biology, or Biochemistry), MS with 5+ years, or BS with 7+ years of industry experience in analytical development or equivalent demonstrable experience with analytical techniques.
    
• Skills & Knowledge
  
  • In-depth experience in analytical techniques such as flow cytometry, potency, ddPCR, qPCR, ELISA, DNA fragment analysis, and metabolic analyses.
  • Expertise with in vitro cell-based assay development, potency assay development, and experience with NK and/or CAR-T cells is desirable.
  • Demonstrate proficiency in experimental design, data analysis, control charts, and process capability assessments using DoE.
  • Excellent interpersonal, verbal, and written communication skills are essential.
  • Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams.
  • Attention to safety, good laboratory practice, and good documentation practice.
  • Experience with statistical programming or software is a plus.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
• The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting is often.
• Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• This position requires the ability to occasionally lift and/or move up to 25 pounds.

Work Environment:

• Will require working with cells and cell lines of human and/or animal origin.
• Will require working with hazardous materials.
• Work in and around common laboratory equipment.
• The regular requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around a laboratory environment.
• 100% on-site work at corporate headquarters in San Diego, CA.
• Evening and weekend work as necessary.

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

For immediate consideration, please apply to careers@shorelinebio.com

Visit our website to find out more about Shoreline Biosciences: https://www.shorelinebio.com/.

NO PHONE CALLS PLEASE.

EEO Employer: Shoreline Biosciences, Inc., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.