Job Description
Company Overview: SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.
Position Summary: Viral Vector Drug Product Development (VVDPD) is a department within a Technology Development Division in SKPT. VVDPD is responsible for drug product formulation, process development and nGMP pilot fill/finish for viral vectors. VVDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. The Senior Scientist will play a critical role in the formulation development team, driving formulation screening, robustness and characterization. This role encompasses development of de-novo early-stage formulations as well as late-stage BLA work packages in support of translation to commercialization of clients’ product. The successful candidate will be responsible for driving various activities, including, but not limited to described below:
Primary Responsibilities: - Design and drive formulation development and DP design for clients and internal efforts.
- Drive innovations through evaluation of novel gene therapy formulation approaches, identification of new instrumentation and testing of emerging platforms.
- Plan, execute and interpret formulation development experiments for various modalities of nucleic acids and non-viral delivery systems.
- Plan and execute studies to understand and control interaction of DP with product contact material surfaces in manufacturing and clinical settings.
- Author/review technical reports, data summaries and CMC related documents required for regulatory submissions.
- Design and support container closure selection and development for gene therapies.
- Contribute to technical discussions aimed at resolution of issues with suppliers, processes, and deviations
- Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
- Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
- Works closely with the MSAT team to ensure that manufacturing processes yield the highest possible DP quality profile.
- Support with timely presentations and updates as necessary to management
- Follow general laboratory safety and training requirements
Education & Experience:
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 4+ years’ experience, MS with 6+ years, BS with 8+ years.
- Thorough understanding of formulation development, biophysical characterization, and stabilization principles.
- Familiarity with clinical preparation and administration procedures.
- Experience with authoring regulatory documents for IND/IMPDs and BLAs
- Experience with formulation development of gene therapies is a plus.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
Physical Requirements: - Prolonged periods of sitting at a desk and working on a computer.
- Standing in a lab or manufacturing setting for more than four (4) hours when applicable.
- Ability to lift up to 15 lbs. at times.
Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.
SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
Job Tags
Full time, Contract work, Worldwide,