Senior Director, Manufacturing

KBI Biopharma • Durham, NC

79d • $189,000 - $262,900

About The Position

The Sr. Director, Manufacturing, oversees the management of all areas of the Manufacturing department, including the upstream processing (cell culture and harvest), downstream processing (purification and bulk filling), and manufacturing support teams. The overall aim is to produce bulk intermediates and/or bulk drug substances while achieving quality, schedule, and cost objectives.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline.
• 18+ years biopharmaceutical industry experience and/or training; or equivalent.
• Broad based knowledge of upstream and downstream processing techniques and equipment.
• Experience with technical transfer is desired.
• Experience working in a cGMP manufacturing environment is required.
• Fluent in reading and writing the English language.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
• Ability to solve practical problems and deal with a variety of concrete variables.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to perform process calculations to complete technical transfer analysis.
• Proficient in MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software.

Nice To Haves

• Experience with technical transfer.

Responsibilities

• Oversees hiring, training, and performance management for all Manufacturing staff.
• Develops an engaged and high-performing team.
• Provides clear direction and balanced performance feedback by coaching, developing, and challenging direct reports.
• Takes timely corrective action in accordance with company policy as necessary.
• Ensures compliance with current federal, state, and local regulations.
• Consults with Human Resources Department as appropriate.
• Serves as a mentor in developing direct reports and other leaders across the site.
• Acts as a liaison between department management/subordinate levels and executive/department manager levels.
• Supports achievement of optimum employee headcount while minimizing overhead and raw material costs.
• Manages the establishment of procedures for maintaining high standards of manufacturing operations.
• Assists managers, supervisors, and other senior staff members in the development and formulation of long and short-range plans.
• Identifies, recommends, and implements changes to improve productivity and reduce cost and waste.
• May lead major projects needed to add capabilities or manufacturing capacity.
• Serves as a subject matter expert (SME) during regulatory inspections.
• Performs miscellaneous duties and projects as assigned and required.

Benefits

• Annual bonus structure for all employees.
• Medical, dental, and vision coverage.
• Paid PTO and holidays.
• 401K matching with 100% vesting in 60 days.
• Employee recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees