General Manager & Site Head, Alachua

Ology Bioservices, Inc.
Job Description
DESCRIPTION

Summary:

The General Manager (will have single point accountability for the Alachua, Florida site and will lead a cross-functional Site Leadership Team (SLT). This position is accountable for the overall manufacturing and on-time delivery of clinical and commercial drug substance and drug product in compliance with cGMP's, global health authority standards, internal and client quality requirements. In addition to manuafacturing, the site will host significant Process and Analytical Development capabilities. The Head of Process and Analytical Development will be a member of the cross-functional site leadership team. The GM role is accountable for executing the site strategic plans, day-to -day oversight and driving overall operational, quality, compliance, staff engagement, EH&S, and financial performance at the site.

The Alachua site has an existing manufacturing building currently in operation. In addition, there is another under construction which will more than double the manufacturing capacity. A new Processes and Analytical Development Lab is also being constructed to support the operation. Hence, the GM in conjunction with the SLT will be responsible for the overall start-up and staffing of the new capabilities and integration into the existing site business processes, standard operating procedures, site policies and implementation of digital applications in collaboration with corporate Digital/IT. The position will partner closely with Global Engineering and Global Digital on the design, construction, commissioning/qualification/validation (CQV) of the plant and operationaly prepare the site to seamlessly transition from design/build/CQV/ to start-up and begin cGMP manufacturing. In addition, the position will partner closely with Global MSST and the Vaccine, Biologics and other Franchises on technology transfer, process development and business development activities leading to customer development and manufacturing projects.

Responsibilities:

  • The Site Leadership Team will include the following functions which will be direct reports of the Site GM: Production, Technology, Facilities, Maintenance & Engineering, EH&S, Supply Chain/Materials Management, Operational Excellence, and PMO/Project Management.
  • The Site Leadership Team will also include the following fuctions which will be indirect reports (site Business Partners) of the Site GM: Quality, Human Resources, Finance, IT/Digital, Process and Analytical Development.
  • The Site GM will work closely with the Site Ledership Team to ensure that strong relationships are built and maintained with Technical Operations functional and Global leadership, specifically in the areas of Quality, GMSST, Global Engineering, EH&S, HR, Finance, Supply Chain, OE, Franchise Leads, and PMO/Project Management.
  • The individual will partner closely with other site heads to build a learning and continuous improvement culture across the board and share/adopt best practices across the network.
  • Provide input in developing Strategic Operating Plan and lead the execution of the plan
  • Build a best in class quality, safety, and continues improvement culture at the site
  • Ensure the site meets/exceeds budgeted financial goals and objectives
  • Champion efforts to improve overall productivity and decrease cost while maintaining high levels of quality, compliance and employee engagement
  • Serve as primary point of contact and foster strong collaborative relationships with all Global and Technical Operations Business Partners (Franchises, Quality, MSST, Engineering, HR, Finance, Regulatory, Legal, Government Affairs) for matters concerning the site
  • Ensure unparralleled customer service and satisfaction always working to resolve any issues in a quality and timely manner
  • Lead the site strategic planning and annual goal setting process, talent and succession planning, OPEX and CAPEX process in collaboration with Finance and HR business partners.
  • Develop and implement strategies to ensure strong community relations
  • Ensure nimble decision making processes
  • Lead organizational changes to continuously deliver improved business results in the areas of quality, on-time and in-full delivery of product, reliability, and overall competitiveness.
  • Ensure strategies and processes are in place for risk management, business continuity, and crisis management specifically related to product supply, quality and compliance, life safety and environmental compliance.
  • Lead Corporate and Network initiatives as requested
POSITION REQUIREMENTS

Qualifications:

  • Strong knowledge of cGMP’s, regulatory and quality requirements for biologics and vaccines.
  • Demonstrated skills and experience building and leading large teams
  • Demonstrated skills and experience in strategic management, planning and execution.
  • Excellent verbal and written communication skills
  • Demonstrated skills in team building, mentoring, coaching and people developement
  • Strong business, quality and financial acumen
  • Ability to manage multiple functions and build strong relationships across a diverse landscape

Preferred Experience

  • Bachelor’s degree in engineering/life sciences/busines or related field. MBA preferred.
  • 15+ years experience leading teams in a biopharmaceutical operations environment.
NUMBER OF OPENINGS 1  
EOE STATEMENT Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender,sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans  
ABOUT THE ORGANIZATION Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer
AA/EEO Minorities/Women/Disabled/Veterans  
POSITION General Manager & Site Head, Alachua  
LOCATION Alachua  
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