Grifols Shared Services North America, Inc Manager, Manufacturing - (Albumin Bulk) in Los Angeles, California
Responsible for direct leadership of manufacturing operations, ensuring production goals are achieved.
Essential Job Duties:
Manages through subordinate supervisors the activities of a section(s) with responsibility for results in terms of costs, methods and employees.
Participate in process/product troubleshooting in order to correct/maintain aseptic processing and desirable product yields, as well as environmental control of facility.
Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product.
Manage and monitor department’s operating budget.
Assume the decision-making responsibility for day-to-day operations considering staff input and collaborating with other GBI functions.
Provide scientific and/or technical advice and counsel regarding projects as needed.
Communicates company and departmental goals to the department’s exempt and non-exempt employees.
Manages large complex projects to bring in on budget, on schedule and technically correct by revising, analyzing and reporting the results against business parameters.
Communicates with cross functional departments and support groups to improve departmental performance and efficiency.
Maintain a quality presence to ensure compliance with all regulatory requirements.
Maintain current knowledge of regulatory and industry standards.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
Provide guidance and hands-on training to direct reports.
Appraise and monitor performance of department personnel.
Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources.
Provide a leadership role ensuring employee health and safety.
Involved in interviewing/selection process of hiring or promoting department personnel.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
Bachelor's Degree is required. Degree in Biology, Chemistry, Chemical Engineering or closely related scientific / technical discipline is preferred.
Minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. Aseptic experience is required.
Equivalency: In lieu of a Bachelor's degree, candidate must have an Associate's degree, and a minimum of 6 years of related experience in a pharmaceutical, GMP, or FDA regulated environment.
Requires an in depth understanding of pharmaceutical manufacturing operations, including protein purification and aseptic processing.
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Minimum of 3 years of managerial, supervisory, or leadership experience is required. Leadership experience in a related industry is preferred.
Demonstrated ability to inspire high performance in others and align team members around shared goals.
Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
Demonstrated project management skills.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 156853