The Principal Scientist will be an associate within the MS&T team. The main responsibility of the Principal Scientist is to lead and mentor Junior level associates to develop robust Upstream processes/assays in support of developing and optimizing production processes including process parameter optimization, process characterization, scale-up/tech transfer for large scale product production and support successful implementation of production processes at commercial scale.
Primary responsibilities for role:
* Develop new techniques, solve complex problems, author technical protocols and reports; and evaluate new instrumentation or process techniques.
* Will monitor, explore and evaluate next generation technologies to speed up process development. This individual will also be responsible for technology transfer to third parties including partners and CMO.
* Independently designs and takes lead with regards to the execution of laboratory-based studies to screen, optimize, and scale production processes, analyzes and interprets results for novel and scientifically complex experiments, participates in process improvement, development, and qualification activities.
* Uses scientific knowledge to make decisions on projects.
* Analyzes data and results and makes recommendations that impact both the science and the business.
* Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.
* Provide technical leadership to staff with focus on verbal and written communications, teamwork, and problem solving.
* Leads cross-functional project teams and directs resources in the preparation of procedures or technical reports.
* The individual will be accountable for scientific data review including data integrity verification, statistical analysis and technical report writing.
* Directly interfaces with other departmental groups such as R&D, Quality Assurance, Regulatory Affairs, Supply Chain and Manufacturing.
* Advanced ability to set and meet deadlines, multitask, as well as to identify, request, and prioritize resources across functional area based on project needs.
Knowledge, Skills, and Abilities:
* Has advanced Technical/Scientific knowledge in professional field of specialization and biopharmaceutical processes, both process development and manufacturing scales of operation.
* Has advanced knowledge and technical expertise in area of protein and monoclonal antibodies production using mammalian host cell systems, experience with microbial based host cell systems for recombinant protein production is a plus.
* Responsible for the design and execution of experiments with regards to cell culture media screening/development, evaluate feeding strategies, process parameter optimization, and scale-up to support large scale production.
* Lead efforts for developing and optimizing cell culture processes including process parameter optimization, process characterization and scale-up/tech transfer for large scale product production.
* Experience with Applikon/Sartorius bioreactors, AMBR and/or other high throughput systems for cellular characterization and process development.
* Experience with different harvesting and cell lysis techniques such as centrifugation/continuous centrifugation (disc stack centrifuge), filtration, dynomill, microfluidzer
* Evaluate and maintain fermentation data in the databases.
* Experience in process technology transfer within and between organizations, manufacturing support and troubleshooting.
* Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
* Influences the development of overall objectives and long-range goals of the organization.
* Design and write up studies to characterize Upstream or Downstream process parameters with high risks identified in the Lifecycle Stage 1 risk assessments to define their criticality and to define Proven Acceptable Ranges (PAR) for Critical Process Parameters (CPPs).
* Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.
* Demonstrated teamwork, organizational, and leadership skills.
* Extensive working knowledge of cGMP environments (understanding of equipment, technology, and quality systems requirements.
* Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
* Skilled in application of standardized root cause analysis, investigation tools and methodologies.
* Proficient with the use of MS Office software(MS Excel, MS Word, MS Powerpoint) and application software including Unicorn, JMP, Minitab, Design Expert etc).
* Bachelor's Degree in science or engineering preferred with a minimum of 15+ years of experience, Masters with 13+ years or PhD with 10+ years in product development, manufacturing science and technology, process engineering within the pharmaceutical industry required.
* 7 years of experience working in a pharmaceutical manufacturing site.
* Leadership and mentoring for junior scientists.
* Process development and characterization including micbobial and mammalian cell culture media screening/development, feeding strategies, process parameter optimization, and scale-up to support large scale production
* Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements.