Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Malvern, Pennsylvania, United States of America
Job Description:We are searching for the best talent for an Exp Sci Biotherapeutics RD. Position Summary The role of Experienced Scientist in TDS-API supports upstream product development. The role is responsible in the execution of timely and effective development of upstream processes for new cell and gene therapies. Leads method development, qualification, validation, and transfer activities and write protocols and reports. The Experienced Scientist will work in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.
Core Duties & Responsibilities - Supports upstream product process development
- Work in a team environment as well as contributing individually to meet project timelines and objectives
Role's Responsibilities: - Supports method development, qualification, validation and transfer activities and write protocols and reports
- Strong ability to interpret metabolites, gassing data to improve cell culture process development
- Lead methods development, qualification, validation, and transfer activities
- Support writing of analytical sections of regulatory submissions and support regulatory filings including INDs and BLAs
- Ability to comply with regulatory and training requirements
- Work at a high level of autonomy, develops upstream processes of early assets.
- Supports all aspects of laboratory and occasional pilot-scale or manufacturing scale
- Leads the processes involved with the preparation and submission of Technology Transfer technical reports, patent applications and manuscripts.
- Leads continuous improvement for methods, processes and/or scientific procedures.
- Proactively investigate, propose, and develop improvements to existing processes or develops new processes.
- Communicates with partnering departments in as appropriate for new assets.
- Analyzes data in highly complex situations involving the evaluation of tangible and identifiable variables to arrive at creative and effective solutions including statistical approaches to establish design space for methods.
- Supports in the scale-up and technology transfer for manufacturing processes.
- Makes a positive contribution to the organization, seeks opportunities for improvement.
Experience Required - Demonstrated experience in cell culture product process development, manufacturing process development, process validations, and manufacturing investigations across functional groups
- Strong background of virology, immunology or bioprocess engineering or related scientific methodologies required.
- Experience in the design and execution of assay validation parameters required.
- Familiarity with statistical methodology such as DOEs, regulations including EP and USP and experience with process excellence methodology desired, but not required.
- Strong problem-solving skills for developing creative, innovative solutions, and meeting project objectives are required.
- Experience working in a cGLP environment is preferred.
- Highly organized and capable of managing/pursuing multiple projects independently.
- Ensures project results, findings and data is communicated to management in a clear and timely fashion.
#LI-OnsiteRequired Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression
