Aseptic Processing SME Sterile Drug Product

This individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for both the internal BMS network as well as external manufacturing partners throughout the US, Europe and Asia. The aseptic processing SME will partner with the manufacturing sites to define strategies for microbial control for DP related manufacturing activities such as gowning, environmental monitoring, media fill program, and will ensure the control strategies comply with Annex 1 and FDA Guidance for Industry. The individual will act as single point of contact for these subjects, will engage with industry forums such as PDA, BPOG, and ISPE, build ties to the micro center of excellence and process microbiology group and will interface with the manufacturing plants as needed in support of establishing and maintaining a cGMP focus on these critical aseptic activities.

This position will report into the Associate Director of Biologics Drug Product Mnaufacturing Science and Technology located in New Brunswick, New Jersey, United States. This position will be located in New Brunswick, New Jersey, United States.

Responsibilities:

• Provide oversight to the media fill program, including elements such as required operator training and qualification, approach to coverage of all products in the media fill program, use of components, and intervention strategy. Review and approve annual media fill programs and aseptic validation master plans for new areas for internal sites
• Provide oversight to the gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintainence of the aseptic processing environment.
• Build a strong network with both the microbiology center of excellence and the process microbiology group, with the aim to provide process support/expertise to rapid microbiology method development and implementation in the production environment.
• Interface with product specific technical teams to consult on microbial sampling during technology transfers and qualification activities.
• Participation in site assessments/vendor selecion for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. May act as SME on Quality audit team for External manufacturing sites
• Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing.
• Leadership and/or support of critical manufacturing or complaint investigations involving aseptic processing components from both the internal manufacturing site and external CMOs, including root cause analysis, CAPA generation, and impact assessment. Addinally supporting triage of microbial investigations to the appropriate microbiology SME within the network.
• Technical input, authoring (when applicable), and approval of CMC documents for process validation P.3.5 sections and support CMC query and resolution with Global Health Authorities, and support of plant inspections.
• Provide oversight/input to sterilization process qualification activities, and review and approve PQ protocols.

KNOWLEDGE / SKILL

Education:

• Strong technical knowledge of sterile manufacturing technology and aseptic processing, with a minimum of 8 years of experience and a BS degree or 6 years of experience and a MS degree is required.
• A bachelor's degree in relevant engineering or scientific discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required.

Experience / Knowledge Desired:

• Subject matter expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of the aseptic/environmental asepcts of these processes.
• Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
• Experience in sterile manufacturing plant(s) with interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
• Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus.
• Strong technical writing skills.
• Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
• Ability to work within and lead cross-functional technical teams, across multiple cultures.
• Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
• Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone,
• Requires approximately 15% travel, between an internal Puerto Rico manufacturing facility and CMOs in various locations in US and Europe
• Demonstrated ability to
  • influence areas not under direct control to achieve objectives
  • work strategically, manage multiple programs consistent with department objectives
  • Work well in a matrix environment and effectively support the decentralized manufacturing function
  • build alignment with business partners including the manufacturing sites, the Micro Center of Excellence, Quality stakeholders
  • manage risk and make rapid decisions

Personal Competencies Desired/Required:

• Strong strategic and analytical thinking, problem solving and rapid decision making skills
• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment
• Strong ability in negotiating and influencing without authority in complex, high impact situations
• Strong presentation and communication skills both, oral and written
• International travel is required

BMS Bio-Pharma Behaviors Required:

• Accountability: We own our outcomes and the outcomes of others
• Speed: We act with urgency and agility
• Innovatoin: We embrace new ideas
• Passion: We pursue excellence to help patients prevail