Associate Director of Upstream, Manufacturing Science and Technology|
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||Jan 09, 2018
||US - Massachusetts - Cambridge
Provide leadership and managerial support for upstream planning, execution and customer interaction for the Manufacturing Science and Technology (MST) during Technology Transfer through to Commercial manufacturing programs. This role will focus on aspects of implementing and profiling robust, scalable and efficient upstream manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.
The Associate Director of Upstream in MST will work closely with the Downstream, Analytical and DP MST groups as well as clients and the Commercial team to support client projects and with Brammer’s Florida site, PD, Quality, EHS, and Manufacturing to ensure compliance and technology transfer. Additionally, the role is responsible for implementation of the process characterization program for Brammer Bio.
• Recruit, mentor and lead a team of scientists, engineers and technicians within MST upstream working on transfer, establishment and scale-up of late phase upstream manufacturing processes.
• Responsible for providing leadership and technical mentorship to the upstream team for clinical and commercial stage products. Provide upstream laboratory leadership to design, implement and analyze laboratory work aimed at understanding, improving, and transferring upstream MFG processes and technologies.
• Hire and develop employees within the Upstream group in support of department, site, and corporate objectives. Organize workflows, provide feedback and coaching.
• Manage technology transfer (from clients and from other Brammer sites) to ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams
• Ensure new MST upstream laboratories are equipped appropriately to meet client needs
• Oversee commercial process validation and associated documentation, as required
• Manage preparation and review of necessary technical documentation
• Responsible for maintaining upstream project schedule for MST deliverables. Coordinate resources to meet upstream MST project objectives and deliverables.
• Manage investigation and data analysis to address deviation and implement change controls
• Manage upstream technical agenda for process improvements, process monitoring and robustness, scale down process characterization (PC) studies and CPV program
• Lead process characterization program implementation
• Provide on-site support during the process validation campaigns and associated documentation and regulatory filings.
• Assist in proposal development and design of Phase III work.
• Represent MST on CMC teams and sub-teams as a Technical Project Lead, as required, to coordinate multi-functional activities for late-phase clinical and commercial programs.
• Work with upstream counterparts in Brammer’s Alachua Process Development and Cambridge Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
• Must stay current with relevant technologies, literature, and forward thinking to identify new approaches.
• Keep current on regulatory and quality requirements and follow Environment, Health & Safety policies.
• A Ph.D. degree in biochemical engineering, chemical engineering, molecular biology, virology, biochemistry and ten plus years of appropriate experience. Excellent technical writing and oral communication skills are required. Non-Ph.D. individuals will be considered based on their pharmaceutical manufacturing/development experience.
• B.S. with 10+ years’ experience, or Master’s degree with 8+ years’ experience, or PhD with 3+ years’ experience.
• Team leadership and people management experience required. This position requires the ability to work in a fast-paceddynamic team environment to meet the timelines and as such requires appropriate behavioral characteristics (attitude, leadership and personal interactions) to be effective and successful. Individual must be self-motivated, have excellent planning skills and be detail oriented. Individual should also be able to manage her/his own time and scheduling of the group effectively
• Technical expertise in upstream biopharmaceutical manufacturing and/or process development. Experience with adherent and suspension mammalian (HeLa, HEK, Vero) and insect (Sf9) cells is required. Knowledge of Stirred Tank Bioreactors (fed-batch and perfusion), flat stock technology including Cellstacks, Hyperstacks and iCellis and various platforms for vector production (transient transfection, stable producering cell lines, and helper virus technology) is strongly recommended. Experience with ATF and hollow fiber TFF highly preferred. Knowledge of at-scale downstream processes as well as applicable modern in-process analytics is desired.
• Expertise in late stage/commercial technology transfer, process characterization and process validation biopharmaceutical/gene transfer vector manufacturing preferred.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
• Knowledge of cell and gene therapy vector production highly desirable.
• Project management skills desirable
• Must have strong strategic skills, along with the ability to be hands-on
• Excellent troubleshooting skills and ability to solve complex technical issues
• Ability to work both independently and as part of a team.
• Strong interpersonal and communication skills, verbal and written
• Successful candidate must have the ability to read and interpret the scientific literature, regulatory guidance’s, and documents such as safety rules. Ability to compile, analyze and interpret complex scientific data; Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers. Ability to make complex mathematical calculations; and follow written and verbal instructions in English. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to communicate in a dynamic environment.
• Some travel is required (10-20%)
Name: Brammer Bio MA, LLC
Address: 250 Binney Street