cGMP Biomanufacturing Downstream Supervisor

DURATION - 3-6 MONTHS - ONSITE POSITION - SHIFT - SUN-WEDS - 10PM - 8AM.

The Senior Supervisor will oversee a team/shift responsible for Downstream manufacturing of biologics drug substance, supporting direct execution and providing leadership oversight. The Downstream Biomanufacturing Senior Supervisor will be responsible for his/her team s execution of production activities including column chromatography, normal flow filtration / tangential flow filtration, viral reduction / filtration, and bulk drug substance filling in a clinical and commercial cGMP environment. S/he will be present on the floor to support execution in compliance with SOPs and GMP guidelines, provide coaching and development to employees, and drive a right first time culture. S/he will ensure batch manufacturing readiness, meet production schedule deliverables, drive a continuous improvement culture, support Person In Plant (PIP), and continually optimize staff and operating model in support of client program requirements and site financial objectives. The Senior Supervisor will coordinate activities and drive standard work with Supervisors of other shifts. This position generally supervises 5-15 direct reports. The Senior Supervisor spends the majority of the time assigning, reviewing, checking work, assisting in the manufacturing suites and eliminating ordinary difficulties. This person also recommends candidates for hiring, termination, prepares and conducts performance reviews and salary reviews, and applies company policies.

Education/Experience:
"Doctorate Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 3 year of relevant experience, OR
"Masters Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 6 year of relevant experience, OR
"Bachelors Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 7 year of relevant experience, OR
"Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 9 year of relevant experience, OR
"High School Diploma with a minimum of 10 year of relevant experience.
"Greater than 2 years of leadership experience.
"Clean room, aseptic technique, and/or general lab equipment experience preferred.
"GMP experience preferred.
Technical Requirements:
"Excellent written and verbal communication skills with internal and external customers.
"Ability to communicate complex technical information to non-technical audiences.
"Maintains data integrity and ensure compliance with company SOP s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines.
"Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
"Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise.
"Begin to provide reliable and defendable interpretations of regulatory guidance for the customer.
"Well organized with ability to handle and direct multiple activities within the group simultaneously.
"Maintains staff by recruiting and hiring, employees, developing personnel growth opportunities, supporting employee motivation and providing strategic alignment with Quality Assurance Department and site initiatives.