Scientist, Drug Product MSAT
King of Prussia, PA
Full Time
Viral Vector MSAT
Mid Level
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:
The Scientist, Drug Product MSAT will report to the Associate Director of MSAT, Downstream and Drug Product and will have responsibilities supporting drug product MSAT technology transfer activities for viral vector pilot and GMP manufacturing campaigns. Candidates may have experience in drug product process development, automated and semi-automated filling, viral vector production, scale up, Tech Transfer, GxP documentation, and technical report authoring and review. Experience in project management and Microsoft Visio is a plus, but not required. The Scientist, Drug Product MSAT will play a critical role in leading tech transfer for associated clinical and commercial vector drug products.
Primary Responsibilities:
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.
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:
The Scientist, Drug Product MSAT will report to the Associate Director of MSAT, Downstream and Drug Product and will have responsibilities supporting drug product MSAT technology transfer activities for viral vector pilot and GMP manufacturing campaigns. Candidates may have experience in drug product process development, automated and semi-automated filling, viral vector production, scale up, Tech Transfer, GxP documentation, and technical report authoring and review. Experience in project management and Microsoft Visio is a plus, but not required. The Scientist, Drug Product MSAT will play a critical role in leading tech transfer for associated clinical and commercial vector drug products.
Primary Responsibilities:
- Work closely with process development and/or client in process knowledge transfer to scale-up process for pilot and GMP operations
- Support Process Fit to Plant evaluation
- Author protocols to support GMP manufacturing campaign where applicable
- Provide planning and logistics support for GMP execution
- Provide hands-on technical support during GMP production
- Author knowledge transfer documentation for GMP manufacture (e.g., bill of materials, process flow diagrams, and sample plans)
- Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
- Collaborate with process development scientists and manufacturing to establish technology transfer plan and perform technical risk assessment for the product/process introduction to the GMP facility.
- Provide technical support for process-related issues or investigations.
Education & Experience:
- BS (4+ years’ experience) or MS (2+ years’ experience) in Chemical Engineering, Biology, or similar life sciences degree with experience in drug product formulation and filling technologies and demonstrated laboratory proficiency.
- Hands-on experience with common drug product formulation and fill equipment, materials and operations (i.e., automated and semi-automated filling equipment, sterile filtration, filter integrity testing, aseptic process simulation, single use systems, etc.) and ability to train junior staff
- Ability to follow procedures with attention to detail and successfully troubleshoot
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Demonstrated ability to maintain detailed execution records and perform data analysis
- Knowledge or experience with gene therapy manufacturing in the biotech industry is preferred
- Strong communication skills (e.g., clear and concise) and a team player
- Strong time and project management skills
- Critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
- Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
- Takes ownership of the assigned project, consulting with management and peers
- Able to understand and interpret data/information and its practical application
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 30 pounds at times.
- Standing/working in a lab/ GMP setting for more than 4 hours when needed.
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.
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