Posted in Other 30+ days ago.
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Type: Full Time
Location: Gaithersburg, Maryland
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Senior Manager will lead and develop upstream (Fermentation and Recovery) processes and assist in the manufacture of product candidates within the process development group. This includes specific processes, scale-up and transfer of processes to target manufacturer (both in-house and external).
Reporting to the Sr. Dir, Process and Analytical Development Responsibilities will include:
* Management of the upstream process development team, developing fermentation and recovery processes in support of Product Development in line with Emergent s BioDefense initiatives.
* Development and optimization of microbial and eukaryotic fermentation processes for the expression of proteins or viral propagation utilizing standard fermentation methods including batch and fed batch; monitoring and analyzing expression of target proteins; standard harvest and recovery methodologies including centrifugation and tangential flow filtration; technology transfer and assist in maintaining the laboratory
* Coordinate process scheduling with Purification, Engineering and Operations, and Assay Development to facilitate cross functional support within PAD in the design and execution of experimental protocols for developing/optimizing manufacturing processes, process scale-up and technology transfer to manufacturing organizations both within and outside Emergent BioSolutions.
* Preparation of experimental protocols, including other forms of documentation such as Technology Development Reports, Technology Transfer Protocols, and generating Operational and Maintenance Equipment SOPs and Manufacturing Batch Records.
* Manage Purification Development s scientific staff and oversee their technical as well as professional goals and development.
* Work in conjunction with other PAD Managers and the Sr. Director to coordinate schedule of support staffing and equipment for various in-house programs and insure schedule and staffing are coordinated
* Develop and maintain microbial and cell culture data bases and data collection.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
* BS with 12-15 years or Ph.D. or MS with 8 to 10 years in biochemical engineering, microbiology, cell physiology or equivalent is required. Extensive knowledge of upstream bioprocess unit operations specifically with microbial and mammalian propagations generating recombinant proteins or virus replications for Vaccines and Therapeutics is a required skill set.
* Detailed knowledge of biochemical pathways of cell lines.
* Hands on experience and scale-up using shake flasks, chemostats, bioreactors, centrifuges, cross flow filtration as well as other cell and viral propagation and protein expression systems.
* Additional expertise in process equipment such TFF and other cross flow filtration systems including separation equipment such as centrifugation.
* Good knowledge of appropriate ICH, European and FDA based regulatory guidelines required
* Matrix based experimental design is required and experience with DOE highly desirable. Extensive knowledge and/or experience are also important.
* Strong familiarity of upstream fermentation and recovery
* Demonstrated successful previous management of bioprocess operations groups.
* Focus will be primarily on protein or viral expression systems utilizing a wide variety of cell lines with methods including centrifugation/cross flow filtration chromatography and tangential flow diafiltration.
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 10 lbs. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Drive automatic/standard vehicle. Work in multiple locations, with restricted access to laboratory, in contact with Select Agents.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.