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 Bioscience is seeking a highly motivated individual to join our growing Process Development team. The incumbent will play a vital role in design, execution and analysis of process development studies to characterize, establish, and transfer innovative, robust, GMP-compatible cell production methodologies for stem cell differentiation, expansion, and harvest of Natural Killer and Macrophage cell products. The Senior Scientist will be responsible for drafting protocols, batch records, SOPs, technical reports. The Senior Process Engineer will collaborate cross-functionally with research, analytical development, manufacturing sciences, regulatory and quality functions to ensure cell therapy processes are built upon current scientific and quality principles. The incumbent will represent CMC team and provide subject matter expertise as part of cross-functional program teams. This position will report directly to the Director, Process Development. The anticipated salary range for this position is $81,000 to $152,000. 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.

Primary Responsibilities

• Lead, design, and execute experiments using sound scientific principles to establish, characterize, and improve processes for stem cell differentiation, expansion, and harvest of allogeneic cell therapy products and further understanding of CPP and CQAs.
• Analyze and trend process data.
• Maintain knowledge and drive implementation of state-of-the-art cell production, automation, and analytical techniques.
• Author, review, and maintain detailed experimental records, production batch records, protocols, SOPs, technical reports, and regulatory documentation.
• Act as subject matter expert for process development and represent CMC function at cross-functional project teams.
• Support process tech transfer activities to internal manufacturing and CDMOs.
• Lead design and execution of process development studies including coordinating personnel needed to deliver timely, high quality data.

Management Responsibilities

• Trains and manage junior scientists and /or engineers.

Qualifications

• Education & Experience
  • PhD degree in Life Sciences, Engineering or relevant scientific discipline and 3+ years of relevant industrial experience; MS in Life Sciences or relevant scientific discipline with 6+ years experience; or BS in Life Sciences or relevant scientific discipline with 10+ years experience.

• • Experience training others to perform cell therapy operations and transferring cell therapy processes GMP manufacturing facility is desired.
  • Prior experience supporting manufacturing investigations, identifying CAPAs, implementing process improvements, designing comparability studies, and drafting technical reports is preferred.

• Skills & Knowledge
• • Demonstrated ability to develop innovative cell process techniques for one or more of the following: primary cell lines, Stem Cells (e.g., iPSC, HSC, ES), CAR-T cells, macrophages, or NK cells is required.
  • Demonstrated ability to independently design, lead, and execute process development studies with minimum supervision.
  • Proficient in methodologies for statistical analysis, data visualization, and design of experiments (DOE).
  • Proficient in operation of suspension bioreactors, cell processing equipment, and cell analytical tools.
  • Knowledgeable in cGMP manufacturing, documentation and regulatory requirements for development of cell therapy and biologicals.

• • Familiarity with ICH and FDA guidance for biopharmaceutical development and cell therapies.

• • Self-motivated and able to collaborate effectively with colleagues to achieve program goals.

• • Excellent interpersonal, verbal, presentation, written communication and leadership skills.
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

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.