Manager/Sr.Manager, Process Validation

This position is responsible for managing a group of Scientists and Engineers whose major responsibility is process validation of viral vector and cell therapy processes and the ancillary activities associated. This incumbent serves as the MSAT PV business partner within the Viral Vector and the Cell Therapy assets at Lonza Houston. The responsibilities of this management role include coaching, mentoring, and providing guidance and technical leadership roles in client-facing projects and/or Lonza strategic projects, establishing new processes and policies, and mediating conflicts, providing technical input and guiding company strategy, prioritizing work and assisting in establishing long term group direction and objectives all related to process validation.

Requirements

• Bachelors of Science in Biological Sciences or Biomedical/Chemical Engineering. Masters of Science or Engineering or PhD preferred
• Manager : 3-8 years of biotech industry experience in people management, Process Validation, Continued Process Verification, Clinical to Commercial manufacturing.
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
• Demonstrated substantial expertise in Biologics and/ or CGT Process Validation
• Working knowledge of requirements for Continued Process Verification (CPV)
• Working knowledge of risk assessment-based process validation, statistical data analysis, Design of Experiments (DoE) and control strategy. Understanding the PV lifecycle including stage I activities sufficient to consult to project teams on necessary approaches for successful commercialization.
• Knowledge should span across both upstream (cell biology, cell culture, scale up, bioreactor operation, centrifugation and filtration) and downstream (protein structure, scale up, chromatography, UF/DF) technologies. Gene and cell therapy knowledge is a plus.
• Superb documentation, organizational, and technical writing skills, capable of providing summaries and reports with little direct oversight
• Ability to work independently and follow through on assignments without direction
• Perform within a dynamic and fast-paced environment and remain calm under pressure
• Attention to details required
• Ability to analyze problems, practices or procedures in order to define the problem or objective, identify relevant concerns or factors, identify patterns, tendencies and relationships and formulate logical and objective conclusions and recognize alternatives and their implications.
• Professional interactions with customers, senior leadership and colleagues
• Offer alternate views and options to opposing direction as well as understanding the obstacles
• Ability to ensure decisions made are beneficial to the business and the team
• Experience with biologics and/ or CGT GMP manufacturing is required (mammalian, microbial, and/ or viral vectors and cell therapies. Exosomes a plus). US/EU PV- relevant regulatory knowledge is required.
  Expertise with industry guidelines including BPOG, PDA and ISPE
• Strong computer skills (including Word, Excel, Outlook and PowerPoint.);
• Demonstrates critical thinking skills in problem-solving and decision-making
• The capacity to motivate and encourage others, in the achievement of specific objectives, and to carry ultimate responsibility.
• Strong and effective listening and communication skills

Responsibilities

Process Validation SME:

Responsible for establishing site policies and procedures supporting the validation of gene and cell therapy processes in alignment with Lonza global policies and procedures and regulatory requirements. Generate Process Validation Master Plans (PVMPs) and Process Validation Protocols and Reports for various manufacturing processes. Support Regulatory inspections (such as PAIs). Ensure work is carried out safely, on-schedule and within quality standards.

Technical Leadership Responsibilities:

Provides technical guidance to MSAT and the Houston site for process validation and commercialization. Able to identify potential solutions and lead multi-disciplinary teams in developing and implementing solutions. Reviews process changes and assesses change controls for impact of process / equipment or procedural changes that can affect both process performance and product quality. Assesses all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products. Authors and revises MSAT PV SOPs and policies. Supports documentation preparation for regulatory purposes. May mentor and lead a team of junior specialists.