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Director of Operations

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Staffing Resource Group

2021-12-03 07:50:26

Job location Brooksville, Florida, United States

Job type: fulltime

Job industry: Executive Positions

Job description

Director of Operations:

  • Title: Director of Operations
  • Location: Brooksville, FL
  • Industry: Pharmaceutical
  • Salary: Based on Experience
  • Employment Type: Direct Placement

Job Scope:
As a critical member of the Site Leadership Team, the Director of Operations is to lead the manufacturing, warehousing, and procurement functions at the site. The successful individual is responsible for building strong working relationships across the site and driving employee and customer engagement to next level and ultimately delivering safe and effective products and services to our customers. The position is responsible for the operational and compliance performance necessary to drive growth, automation, customer delivery and a quality excellence culture. Working cross-functionally with Quality, Program Management, HR, Formulation/Process Development, Validation, Business Development and Finance, the Director will be responsible for organizing, managing, and improving unit operation activities in support of the development of new products or processes and the manufacture of clinical and commercial products according to cGMPs and Right First Time. The role is also responsible for building both a high performing team and high performing systems to drive and sustain business growth and to meet the demands of a complex customer base.

Duties and Responsibilities:

  • Direct manufacturing staff to ensure the timely delivery and Right First Time execution of manufacturing operations for development projects and manufacturing batches.
  • Ensure that all operations are compliant with EHS Standards and OSHA and EPA requirements at all times. Promote and ensure a safety culture with areas of responsibility.
  • Ensure all company and site policies are adhered to and ensuring appropriate company disciplinary policies are followed consistently.
  • Build, maintain and motivate a multi technology operations team capable of achieving all productivity targets and output requirements to service customers with product on time - In Full and Right First Time.
  • Assist the COO in establishing strategic direction for manufacturing resources and activities and setting objectives to maximize the value of the organization's contributions by adapting new technologies, capabilities and providing educational opportunities for team members.
  • Maintain the operational facility at a high level of cGMP compliance per FDA, EME and customer expectations.
  • Develop quality and business metrics for assessing productivity/profitability of manufacturing.
  • Develop and manage the budget requirements for each fiscal year. In agreement with the Site Head, organize the purchase of appropriate capital items as required for projects. Monitor and control expenses to optimize cash flow timing and continuous improvement to reduce COGs.
  • Cross functional collaboration with Validation, Quality Assurance, Analytical Services, and Project Management functional areas to plan and implement the execution of cGMP activities in manufacturing operations for both development processes and commercial operations.
  • Ensure continued operational efficiencies are realized with reliable schedule adherence, and on time delivery of product, while maintaining the ability to react to changing customer requirements.
  • Provides recommendations for revisions or enhancements to schedules, resource allocation and production requirements
  • Share responsibility for short and long term resources and facility planning, and perform managerial duties as required, e.g., budgets, personnel performance appraisals, training, etc.
  • Monitor and report progress of projects within agreed upon timelines, ensuring customer and Company objectives are met.
  • Ensure Facilities and Maintenance standards are maintained for the maintenance and calibration of equipment/facilities to support manufacturing.
  • Responsible for participating and representing all manufacturing operations in client or regulatory audits as appropriate.
  • Develop and lead a culture of learning, respect, and employee growth. Establish the department's strategic vision and mentor the manufacturing team towards goal achievement.
  • Monitor and review performance of direct reports, and provide prompt and objective coaching, mentoring, and counseling. Resolve performance, job satisfaction, and interpersonal issues, balancing employee and department needs.
  • Liaise with vendors and suppliers as a technical representative.

Education/Experience:

  • Requires minimum Bachelor's degree in a Scientific or Business discipline with 10+ years' relevant experience in Pharmaceutical Operations with 6 years of this being in a managerial position.
  • Experience in logistics/planning of clinical manufacturing operations is preferred.
  • Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
  • Significant experience with Sterile Fill-Finish Manufacturing.
  • Experience in deviation and technical investigations.
  • Superior customer service orientation with strong follow-up skills and attention to detail.
  • Strong quality mindset and partnering with the Quality unit.
  • Strong business orientation and financial skills.
  • Ability to "get the job done" and take responsibility for results without direct authority.
  • Excellent verbal, written and presentation skills.
  • Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence
  • Ability to successfully work within a small company atmosphere with a "roll up the sleeves, all hands-on deck" team environment.

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.


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