Senior/Principal Scientist, Large Volume Parenterals (Technical Operations) - August Bioservices
Nashville, TN 37201
About the Job
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow.
August Bioservices is seeking a Senior Scientist, Formulations reporting to the Sr. Director of Technical Operations. The candidate will serve as a product development expert for aseptic product design and is a core team member for customer facing collaborations. An understanding of pharmaceutical product formulation design and selection of excipients for optimal product shelf-life is required. Knowledge and expertise in Biologics is preferred. Technical understanding and application of current equipment, process controls, identification of support utilities and sampling technologies is an important competency as they relate to formulation development, optimization, and technology transfer of small and large molecule fill/finish operations.
The candidate will be added to a growing team responsible for representing the IV bag value stream that August Bioservices offers and drives the study planning, execution, process development and commercialization efforts in collaboration with our clients and will be supported by an already knowledgeable and competent group of subject matter experts in small and large volume parenterals.
The Senior Scientist is responsible for tasks associated with the technology transfer for sterile drug products and Biologics for primarily large volume parenteral formats in flexible IV bag primary containers. The responsibilities include working with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to identify product and process criticalities and finding scientific data driven solutions to any Technology Transfer process.
Responsibilities
- Lead key opinion to internal and external stakeholders for product formulation development and optimization strategies including selection of formulation design, selection of excipients, selection of primary containers and experimental strategies to achieve client goals
- Lead key opinion for the selection of flexible IV bag primary containers based on an understanding of drug product compatibility for long term storage
- Experience with primary container compatibility challenges for both small and large volume parenterals
- Experience in Pharmaceutical aseptic process implementation including sterile filtration
- Experience in peptide and large molecule formulations, emulsions, lipid nanoparticles and liquid solutions
- Experience in developing technical recommendations in support of new experimental study designs
- Experience with statistical tools for the evaluation of complex data sets
- Experience with evaluation of the performance of polymer-based primary container systems (IV Bags, Copolymer prefilled syringes etc…)
- Experience developing content for CMC regulatory submissions in NDA, ANDA, BLA and IMPD (and other equivalent global regulatory environments)
- Work with Technical Services, Facilities and Validation team on product/process implementation to develop a detailed plan based on the approved scope of work
- Review of technology transfer or R&D scope documents such as pre-clinical formulation data, batch manufacturing and/or packaging process data and will provide the technical analysis for the overall process.
- Leads development of experimental scopes of work in collaboration with Business Development team and engage with prospective clients to review and revise scope
- Prepare data summary presentations, compile experimental and analytical results and observations, perform data interpretation, and summarize conclusions and recommend subsequent steps.
- Support peer review of protocols, data reports and Master Batch Records as assigned
- Incorporate Quality-By-Design (QbD) approach in the product development program to improve the drug formulation and manufacturing process.
- Investigations and Corrective Actions analysis and support as required
- Mentor other team members to develop skills and expertise
- Troubleshoot and resolve complex issues, diagnosing technical problems and identifying short and long-term solutions
- Proficient in quality system software such as Master control and related task such MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents.
Education & Skills
- The candidate requires B.S. in Pharmaceutical Sciences (or equivalent), M.S. in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent).
- The candidate requires B.S. in Pharmaceutical Sciences (or equivalent) with 7-10 years of experience, M.S. in Pharmaceutical Sciences (or equivalent) with 4-7 year of experience, or PhD in Pharmaceutical Sciences (or equivalent) with 3-4 years of experience.
- Knowledge of pharmaceutical processing technologies such as mixers, transfer pumps, temperature control devices as they relate to compatibility with formulation design
- Knowledge of appropriate process requirements for sterile operations including: compounding, sterile filtration, aseptic formulation, sterile filling for vials, pre-filled syringes and flexible IV bags
- Software: Minitab® (or equivalent), Microsoft Office®, Microsoft Visio, etc.
PI250446417
Source : August Bioservices
