Manager, Manufacturing Technical Support (Steriles Operations)
This role is located at our Greenville, North Carolina site. Relocation assistance has been approved for the successful candidate.
Plans, manages, leads and controls the activities necessary to provide expertise that will support Operations in project support, technical investigations, process support and troubleshooting, and process optimization. Participates in capital expansion projects. Aids in identifying and implementing quality and cost improvement initiativesand continuous improvement projects in Sterile Manufacturing.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Provides leadership to staff for the timely execution of deviation investigations and corrective/preventive action implementations, process monitoring, process troubleshooting, and continuous improvement projects.
Provides leadership to staff in the writing and management of department Standard Operating Procedures (SOPs), Batch Production Records (BPRs), Training documents, Protocols, etc. to ensure operational excellence and regulatory compliance.
Ensures technical support of new dosage forms and processes according to customer requirements.
Assures that processes are safe, reproducible, cost effective, environmentally sound and can be successfully validated and transferred to production operations in order to meet agreed standards and require minimal continuing support.
Provides technical support for the production of clinical supplies such that customer and regulatory requirements are met.
Ensures that the Chemistry, Manufacturing, and Controls (CMC) portion of regulatory submissions are based on sound science and written to current standards with the reviewer in mind.
Assists and reviews the preparation of appropriate CMC Documentation.
Works with the Client Departments to introduce new technology and resolve problems as needed.
Recruits, hires, retains, trains, and motivates a scientifically competent staff.
Prepares performance plans for direct reports and conducts performance evaluations as outlined by Company policy. Promotes career development for staff.
Defines resource needs (capital, expense, and headcount) so that current and future development needs are met.
Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Performs other duties as assigned.
Provides tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules. Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the company.
Manages the coordination of the activities of a section or department with responsibility for results.
Bachelor’s degree in a scientific or related discipline is required.
Five years of relevant experience in an FDA regulated industry that includes at least three years of demostrated leadership is preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the customer, including tact to handle sensitive matters. Highly effective verbal and written communication skills. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds, occaisonally pulling up to 50 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.