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Director - Life Sciences GMP Production

Company: Pace Analytical Services LLC
Location: San Diego
Posted on: September 24, 2022

Job Description:

SUMMARY:Responsible for overseeing the development and implementation of life sciences production and GMP lab, services, programs, performance and metrics, policies, and procedures from a functional or technical perspective, including validating and auditing results, scheduling, services, and resolving service and customer problems for the entire department; provides advanced professional assistance to management staff in the GMP area and related matters. Oversight includes multiple departments/functions. The Director reviews GMP documents and participates in process investigations and deviations while ensuring GMP compliance and inspection-readiness. This role will have several GMP operators as direct reports.
ESSENTIAL FUNCTIONS:This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.

  • Plans and orchestrates various manufacturing tasks under the guidelines of established SOP's and cGMP regulations.
  • Manages expectations of leaders, directors, staff, and operations, facilitates communication on customer needs and business requirements, and establishes performance metrics; contacts are diverse and very complex.
  • Manages GMP staff including hiring, training, development and engagement of self and team members, evaluating performance, providing compensation recommendations, and performance management.
    • Provides observations and recommendations to leadership for improvement of the organization's policies, procedures and practices on lab and services.
    • Resolves escalated, technical or sensitive customer and operational problems or conflicts; works with internal groups or external agencies as needed and oversees the successful resolution; areas are very complex to specialized.
    • Reviews deviations, OOS and any other investigations pertaining to the group.
    • Partners closely with QA and QC teams to ensure timely release of manufactured material
      • Schedules manufacturing tasks under cGMP guidelines and under minimal supervision from manufacturing upper management.
      • Supports master production record authoring by their team
      • Initiates and writes revisions to current GMP/SOP guidelines. Reliably executes and writes well defined SOP's and manufacturing batch records.
      • Provides input and advice regarding developing and aligning strategies and GMP programs to manage the clean suite, lab, services, policies, and procedures for the GMP area.
        • Manages and participates in operational, instrumentation and equipment reviews; assists with ensuring compliance with federal, state, local, and institutional standards, regulations, and policies, uses fair practices in the handling of area issues.
        • Manages the group or area budget including allocating resources and approving expenditures under control; budget is large in nature and includes multiple areas. Develops and manages metrics.
          • Oversees or participates in special projects by identifying company, department, customer or service issues and priorities; communicates, coordinates, and evaluates results.
          • Maintains currency of lab, services, industry trends, current practices, new developments, applicable laws, and related legislation.
          • Contributes to the efficiency and effectiveness of the GMP department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
          • Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
            QUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
            Education and Experience:Bachelor's degree in chemistry, biology, or a closely related field; AND eleven (11) years of laboratory or life science manufacturing experience, including minimum of seven (7) years of supervisory experience; OR an equivalent combination of education, training, and experience.
            Required Certificates, Licenses, and Registrations:Continued employment is contingent upon all required licenses and certificates being maintained in active status without suspension or revocation.
            • None.
              Required Knowledge and SkillsRequired Knowledge:
              • Comprehensive principles, practices and techniques of lab and services, such as GMP manufacturing and aseptic processing.
              • Demonstrated ability to create and model detailed directions in a manufacturing GMP environment.
              • Understanding of the development and implementation of GMP area programs, policies, and procedures; includes multiple or broad areas.
              • Principles and practices of developing teams, motivating employees, and managing in a team environment.
              • Principles and practices of budget development and administration.
              • Applicable lab, services codes, and regulations.
              • Computer applications and systems related to the work.
              • Understanding of dealing with a variety of individuals from various socio-economic, ethnic, and cultural backgrounds, occasionally where relations may be confrontational or strained.
              • Principles and techniques of providing effective oral presentations.
              • Principles and practices of program planning, development, and evaluation.
              • Principles and techniques of making effective oral presentations.
              • Correct business English, including spelling, grammar, and punctuation.
                Required Skills:
                • Performing comprehensive professional-level lab and services in a variety of assigned areas.
                • Overseeing and administering comprehensive and varied GMP area functions.
                • Supervising and evaluating employees and providing related recommendations.
                • Training others in policies and procedures related to the work.
                • Applying business and project management methodologies with a focus on implementing plans to achieve goals.
                • Developing effective work teams and motivating individuals to meet goals and objectives and provide customer services in the most cost effective and efficient manner.
                • Interpreting, applying, and explaining applicable laws, codes, and regulations.
                • Providing GMP consulting services to supervisors and staff.
                • Preparing functionals reports, correspondence, and other written materials.
                • Using initiative and independent judgment within established organizational and department guidelines.
                • Using tact, discretion, and prudence in working with those contacted in the course of the work.
                • Performing effective oral presentations to large and small groups across functional peers and the department.
                • Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities.
                • Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.
                  PHYSICAL/MENTAL REQUIREMENTS:The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
                  Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
                  WORKING ENVIRONMENT:Work is performed in lab, office, and field settings. Work is subject to exposure to blood or bodily fluids, chemicals, fumes, gasses, noxious odors and related items in a lab and environmental setting. Work can also be subject to travel.
                  #STAR

Keywords: Pace Analytical Services LLC, San Diego , Director - Life Sciences GMP Production, Executive , San Diego, California

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