Sr. Scientist Downstream Manufacturing Gainesville, FL Area
Kelly Scientific Resources is looking for a Senior Scientist specializing in downstream manufacturing at a biotechnology company in the Gainesville, FL area. This posiiton will primarily utilize AKTA instrumentation and will focus heavily in a GMP and cleanroom setting. This is a direct hire opportunity. Monday-Friday on the 1st shift. Salary will be commensurate with experience.
The Senior Scientist will support cGMP manufacturing activities to ensure that the company provides clients with investigational materials for pre-clinical and clinical use. The incumbent will perform hands on cGMP purification of viral vectors under the supervision of the Downstream Manufacturing leadership. The incumbent will work with the Downstream and Upstream Manufacturing Managers and supervisors. The incumbent will also review executed records related to production activities, assist in writing deviations, investigations, etc. related to cGMP production.
This position is expected to lead the GMP manufacturing team in the production module, who is expected to organize the production schedule, personnel, equipment, and space. It is a requirement to work across teams to schedule critical operations.
The incumbent is expected to draft documents (SOPs, PBRs, etc) required for cGMP production, to assist in maintaining equipment in the production suites and to order equipment and participate in installation and qualification if needed. The incumbent will also work closely with Facilities, Quality Assurance, and Quality Control units to achieve production goals and timelines.
This positions will need to be available to train in process development leading to transfer of same to production, as well as preparation of data for review, and the organization of experiment and production results for reports.
Essential Duties And Responsibilities
• Production (40%)
o Lead production suite preparation and/or request necessary components and raw materials, labels, etc. to successfully execute production batch records.
o Develop personnel, equipment, and production module schedules to ensure that downstream manufacturing modules operate efficiently to meet timelines and schedules.
o Lead and perform hands-on activities following detailed protocols, PBRs and SOPs, to complete production runs in an efficient, safe, and correct manner. Document all steps in production runs with minimal errors.
• Prepare and review documents (30%)
o Working with the Downstream manager, lead the draft process procedures including SOPs, PBRs, methods etc. for new processes or equipment. Ensure that documents are accurate and reflect the process to be performed.
o Source cGMP compatible equipment.
o Delegate and lead the writing of deviations, planned variance, change control forms as required.
o Lead the review of executed Production Batch Records (PBR), and other production related documents.
• Process development and improvement (15%)
o With the assistance of the Downstream Manufacturing Manager develop and/or optimize for downstream processes for manufacturing.
o Lead the technical transfer of processes from Process Development laboratories to manufacturing.
o Cross train and perform hands-on activities in Upstream processes as required.
• Other duties as assigned (5%)
o Participate in meetings with clients and planning meetings.
The individual in this position will meet with the Downstream Manufacturing leadership on at least a weekly basis to discuss goals, planning, and progress. In general, individual must work independently and within a group in completing assignments after required training. This individual will supervise the production module and have responsibilities for scheduling the production module personnel, equipment, and production module.
Position(s) supervised: Senior Scientist, Scientist, and Technician
Qualifications - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education And/Or Experience
• A bachelor’s in an appropriate area of specialization and five years of work experience.
• Working knowledge of MS Office.
• Flexibility, self-motivation, efficiency, and responsibility.
• Strong work ethic, desire to be an integral team member and player, and ability to learn quickly and ask questions.
• A bachelor’s or Master’s degree in an appropriate area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry).
• Hands on industrial and/or academic laboratory experience with protein separation technologies (AKTA, FPLC, column chromatography, tangential flow filtration).
• Hands on knowledge of program of chromatography and tangential flow filtration systems.
• Working knowledge of modern laboratory procedures. Knowledge of cGMP, large scale separation and purification techniques.
• Outstanding planning, organization, multitasking, and communication skills.
• Familiarity with gene therapy vectors and knowledge of local, state and national regulations for working with biologics is a plus.
• Strong verbal and written skills in English required as well as effective interpersonal, technical, and troubleshooting skills.
• Mathematical ability to develop formulas for preparation of buffers based on normality, molarity, etc
• Experience in protein expression platforms (insect cell culture, mammalian cell culture, bacterial cell culture).
• Experience performing assays, e.g. pH measurement, conductivity measurement, ELISA, SDS-PAGE, Western blot, qPCR is a plus.
• Ability to interpret data from various sources.
Language, Mathematical, And/OR Reasoning Ability
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Ability to apply concepts of basic algebra and geometry.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to communicate in a high-pressure environment. Ability to maintain accurate records.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Ability to gown aseptically to enter cleanroom. Ability to stand for long periods and wear a respirator.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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