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Sr Manager, Process Validation

Location: 

Baltimore (Bayview), MD, US, 21224

I.  JOB SUMMARY

 

The Sr. Manager of Process Validation within the Manufacturing Sciences and Technology department is responsible for ensuring leadership of the Process Validation team and overall PV strategy and execution at the Baltimore Bayview site. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals on manufacturing process and validation, which includes biopharmaceutical best practices, statistical analysis, regulatory requirements for validation, among others.

 

This role includes cross-functional collaboration and partnership with Manufacturing, Quality, and MS&T leadership, and customers to develop and execute on the PV strategy.

 

This is a hybrid role (both on-site at the Baltimore site and partially remote).

 

II.  ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

 

  • Engage with MS&T Leadership Team to ensure appropriate alignment of resources to support site projects and routine operational needs
  • Maintain good working relationships with internal and external partners/customers
  • Responsible for working with applicable Project Managers to ensure departmental resources are appropriately allocated based on work scope and technical needs.
  • Track and report status on progress against plan and ensure commitment to key stakeholders are met in a timely and high-quality manner
  • Apply scientific rationale and validation expertise to develop process validation strategies to support scientifically sound and robust regulatory applications
  • Develop and support execution of Continued Process Verification strategy with MS&T team
  • Provide oversight of Validation department and Validation Processes
  • Provide oversight of MS&T Validation Activities including hold studies, filtration and extractable/leachable studies
  • Support Process Validation during FDA and other regulatory agency inspections
  • Participate in review of contract negotiations for potential customers as applicable to validation)
  • Validation lead and approver in authoring or reviewing of various compliance documentation such as deviations, CAPAs, change controls, technical study protocols and work orders
  • Lead and support initiatives ensuring department and site Validation Compliance including training, communication forums, continuous improvement
  • Lead change in a positive manner through department
  • Identify and manage talent through requisite HR systems (hiring, compensation, performance management and development) in ways that provide value to both company and employees   
  • Manage the IPMP for direct reports and mentor associates to facilitate professional and departmental growth
  • Assist in the management of the Validation Department budget

 

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

 

III.   MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Degree (Bachelor to Ph.D.) in a related field with a minimum of 8 years industry experience including manufacturing in a regulated environment under cGMPs
  • Experience in managing scientists/engineers in a fast paced, challenging environment. It is essential that this leader creates an engaging workplace with a strong focus on strategy and developing and empowering people
  • Proven track record of management and leadership effectiveness
  • Strong knowledge of ICH guidelines and QbD principles applicable to a manufacturing environment, with successful application experience
  • Diverse and demonstrated technical knowledge with strong risk management mindset
  • Strong technical and communication skills: oral/written and listening. Must have good verbal skills - the ability to communicate clearly and extemporaneously to a variety of audience types.
  • Must have good written communication skills - the ability to tailor communications to all levels in department and prepare appropriate updates to senior management.  Must have effective communication skills for “upward” and “downward” audiences.
  • Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
  • Computer skills (MS Office, JMP/MiniTab or equivalent statistical software, Visio, MS Project)

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore