Sr. Lab Manager

Job Description
AbbVie is recruiting for Sr. Lab Manager (or Associate Lab Director), Drug Substance Development position in the Department of Neurotoxin &
Biologics Process Sciences (NBPS), at its Irvine, CA site.
Position Description Summary:
The candidate, Drug Substance Development will be an instrumental team member of the NBPS group. The primary roles of this position are to lead the team and to execute fermentation, harvest and purification activities at up-to 50L scale in Bio-Safety Level 3 laboratories for the drug substance process development and optimization studies for natural and recombinant proteins (including neurotoxins) from bacterial cultures.
The successful candidate will play a critical leadership role in the lab. The role includes directly supervising personnel in the R&
D laboratory and as a working manager who functions like a player coach, who not only supervises the lab, but also does hands-on biologics process development. This pivotal role involves overseeing daily operations and team within the laboratory setting performing a variety of tasks in support of fermentation and purification related activities. The desired candidate will have a solid understanding and hands-on work experience with production fermentation, harvest/clarification, and purification of biologics proteins. The successful candidate will lead the team and perform laboratory work, develop productive collaborations and communications with other groups across scientific disciplines and be motivated to innovate and succeed in a fast-paced, collaborative environment.
Key Duties (including but not limited to):
Lab operations:
Maintains NBPS’s BSL3/BSL2 lab infrastructure to enable structured and efficient laboratory operation.
Technical know-how of specialized and routinely used equipment and laboratory techniques used in the laboratory.
Supervising laboratory R&
D activities, encompassing routine and specialized operations.
Serve as key point of contact for BSL3 lab team, fielding service requests, assigning tasks, providing training and helping to maintain a culture safety and select agent and toxin compliance.
Hands-on role and is responsible for overall daily operations, including capital plan/expenditures (from forecast to installation), lab equipment and instrumentation (i.E., contracts, maintenance, repair, calibration, upgrade and retiring), and lab consumables (i.E., contracts, procurement, order management, inventory management).
Anticipate, troubleshoot, and resolve problems associated with work within the laboratory setting, including off-hours responses to laboratory emergencies.
Provide strategic direction, technical supervision, and support to the lab operations team who supports day-to-day operations.
Demonstrates effective attention to details, problem solving methodology, root cause analysis, and Good Documentation Practice (GDP).
Proven skilled in 5S Lean management of laboratory operations and accountable for developing and enforcing continuous 5S laboratory practices and annual laboratory cleanup activities, with support from responsible laboratory scientists.
Accountable for overall performance across lab operations and delivering the project needs.
Laboratory safety:
Responsible for ensuring that the laboratory environment is safe for staff and visitors including enforcing safety regulations, providing safety training, and maintaining safety equipment.
Solid knowledge of necessary lab safety procedures and requirements, as well as chemical disposal guidelines.
Responsible for SOPs development and implementation of departmental specific policies and procedures to ensure that the laboratory is functioning effectively and efficiently.
Conduct regular safety inspections and audits of BSL3 and BSL2 labs to identify and address potential hazards.
Train and educate laboratory personnel on safe handling of equipment and materials.
Partner with key stakeholders and continuously strive for a proactive, high bar safety culture.
Work with EH&
S department and maintain select agent and toxin compliance, lab incident management and lead/assist with CAPA, exposure risk assessments, chemical hygiene, and hazard communication.
Work with EH&
S department to ensure the laboratories are compliant with all environmental and safety regulations.
Leadership/Supervisory Responsibilities:
Responsible for managing the lab staff, including hiring, training, and supervising employees.
Leadership skills associated with planning work assignments, establishing priorities and scheduling instructional space.
Lead operational performance reviews and establish NBPS, business and individual objectives.
Proven leadership skills in developing and mentoring junior staff.
Address any personnel issues and concerns in a timely and professional manner.
Proven ability to be an effective team leader and/or supervisor to recruit and retain talent.
Develop and realize a service model with clear roles and responsibilities and decision making.
Optimize lab resources and utilization through close partnership with lab stakeholders and occupancy planning.
Budget management:
Responsible for managing the laboratory budget, including allocating funds for equipment and supplies.
Work very closely with procurement and the lab teams on CAPEX / OPEX budget and ordering lab assets and service contracts.