Sr. Director, Manufacturing Operations

Location
Canton, MA, US
Posted
Sep 06, 2020
Ref
627690900
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY

The Sr. Director of Manufacturing Operations, as a member of the Site Leadership Team, will lead the planning and execution of activities for the Manufacturing, MTECH, and CQV teams. This position will lead and coordinate the required internal resources to develop and execute the near and long-term site strategy to maximize manufacturing outcomes, and proactively plan for changing conditions. This position requires collaboration across the organization to deliver on site goals, operational excellence initiatives and quality improvements. This position is located in Baltimore, MD at our Canton site.

ESSENTIAL FUNCTIONS
  • Oversight and management of the Upstream and Downstream and Central Services Manufacturing Operations, Manufacturing Technical Sciences (MTECH), and Commissioning, Qualification, Validation (CQV) staff to meet the site schedule and objectives.
  • Participate as a key member of the site Senior Leadership Team (SLT) by proactively engaging cross functionally to achieve site goals and priorities. Ensure that reporting staff understand the shared accountabilities for goals and priorities.
  • Provide effective strong leadership to the needs of the organization through a demonstration of Emergent Core Values, experience, and judgment that promotes a culture of accountability and operational excellence.
  • Lead, develop, and mentor department management staff, emphasizing functional and cross-functional teamwork, planning, follow-up, and effective communication.
  • Accountable for project deliverables, adherence to the cost center (OPEX) budget and development and management of Capital expenditure for Manufacturing.
  • Accountable for maintaining the Pilot Laboratory and development activities meeting deliverables timelines.
  • Ensure maximum compliance with current Good Manufacturing Practices, Good Distribution Practices, OSHA, USDA, and other areas of mandatory regulatory oversight.
  • Management of production areas in a safe and compliant manner; participate in and ensure manufacturing departmental compliance for both internal and external audits
  • Manage product life cycle from transfer of processes from pilot laboratory to production; includes but is not limited to process maps, risk assessment, safety review, generation of batch records and SOP's, change controls, process controls, process validation.
  • Provide technical guidance for complex manufacturing operations.
  • Resource planning, staff development and talent and performance management.
  • As required, author, review and verify the regulatory documentation related to the Manufacturing Process.
  • Champion for continuous improvement and operational efficiency to eliminate waste and reduce COGS with the manufacturing operations
  • Assist with development and maintenance of the Site Master Plan.
  • Develop and maintain performance metrics for site manufacturing activities and communicate department progress to management and staff.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

EDUCATION, EXPERIENCE & SKILLS
  • Bachelor's Degree in Life Science or Engineering; Master's Degree preferred
  • 12-15 years technical experience in a biological cGMP manufacturing environment including a minimum of 5 years in a Director level management capacity with demonstrated people leadership experience
  • Must exhibit strong leadership skills, both with subordinates and peers, with emphasis on relationship development and implementation of company culture improvement initiatives.
  • Must have excellent written and oral communication abilities, including:
    • The ability to present complex theoretical concepts and empirical performance data effectively in both oral and written formats, for audiences ranging from senior executives through entry level employees.
    • The ability to communicate clearly and engage in dialogue with all levels of employees in an inclusionary manner.
  • Must be able to influence with others in a fast-paced, cross-functional, and matrixed environment that emphasizes network and site needs as a priority
  • Strong attention to detail is required
  • Extensive experience with cell culture and bioreactor processes
  • Extensive experience with FDA audits and regulatory requirements for operating in a cGMP facility
  • Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint, Visio)
  • Familiarity with specialized industry software applications (SAP, JMP, TrackWise, Documentum) preferred but not required.


PHYSICAL / MENTAL DEMANDS
  • There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
  • This information is available upon request from the candidate.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.


NOTE: Requires vaccination against different viruses including Vaccinia virus and Japanese Encephalitis virus.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.