Environmental Monitoring and Aseptic Process Manager
About the Job
Accountable for managing all the Aseptic Process Microbiology Laboratory activities, including the environmental monitoring program, and for leading the Microbiology laboratory personnel in charge of the Environmental Monitoring. Fully accountable for the knowledge transfer of the microbiological concepts and methods. This position must comply with all Security Guidelines, Environmental Health & Safety regulations and the current GMP required by the job function. Provides support to the Aseptic Program progressing (including the media fills and air pattern simulation coordination of activities with Manufacturing, Supply Chain and Technical Services Areas), the Site Environmental Review Committee (ECR), and to the Aseptic Techniques Practices Program (based on scientifically sound approach). Leads and supervises Microbiology Laboratory personnel in order to\: assure compliance with laboratory policies and procedures and enforces the compliance of BMS policies, GMP, GLP and regulatory agencies such as FDA, EMEA, WHO, ANVISA, etc.; ensure that all personnel is trained and qualified in their respective tasks, enforces the correct use of personnel protection equipment and compliance with BMS safety policies and OSHA, ensure that personnel attend all safety and GMP talks and any other mandatory training according to plant requirements, implement system to guide and motivate the personnel under his (her) responsibility to perform at the maximum potential, be in compliance with HR staff related activities such as\: hiring/termination, recognition/disciplinary action, and performance appraisal. Provides support in performing environmental monitoring and equipment troubleshooting. Lead the coordination of EM sampling and utilities/gases sampling with their corresponding microbiological testing. Leads coordination of protein concentration, conductivity and pH to in process samples during second and third shift. Approves OOS and Quality Events Investigations, including CAPAs, ensuring that are closed within the required time frame in addition to verify that root cause and CAPA identified are based on a solid scientific rationale/APRs reports and QC trends. Identifies unusual EM and utilities/gases trend results. Approves final reports/revision of SOPs and ensure that 100% of personnel are trained prior to the effective date. Leads and influence site departments to ensure commitments and objectives are met in addition to solve problems within the required time frame. Measures key performance indicators in his (her) area of responsibility. Prepares section annual budget, provides headcount analysis as compared with projected hours and ensures the laboratory expenses re according to the approved budget. Leads site/inter-site meetings as required. Supports the Microbiology Associate Director in his (her) absence. Develops mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs. Prepares CARs as required based on actual and future needs according to budget and provide required follow up. Coordinates, evaluates and implements projects for area productivity including the implementation of new laboratory equipment and methods. Establishes short and long range plans for the timely and efficient execution of the microbiological testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, DEA, Police department, etc.). Participates actively in Quality Council and other company presentations and provide recommendation for improvements. Promotes and models the BMS Core behaviors, facilitates teamwork, and provides coaching and feedback. Supports all site initiatives and any other assignments based on business needs. Verifies consistency with other sites procedures and/or specifications. Verifies compliance with BMS Policies and Guidelines. Supports the Media Fill activities in order to assure that typical and atypical interventions are performed as established and that new ones are evaluated and integrated as required. Helps to ensure the aseptic techniques, cleaning and sanitization validations for clean rooms and isolators, HEPA Filter and Gowning process are adequate and effective. Participates in the Environmental Review Committee covering also the utilities. Interfaces directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place, through the execution of thorough reviews of procedures against practice. Supports the clean rooms classifications qualifications and re-qualifications. Assures that the manufacturing operations (Parenteral and/or Oral Solid Dosage) are performed in compliance with domestic and international cGMP regulations, and BMS policies and procedures. Participates in the critical review of all documents associated with the manufacturing aseptic and; leads aseptic processing special projects to accomplish company goals and objective on a timely and effective manner. Provides formal presentations to upper management on environmental monitoring trends and aseptic processing status and opportunities as applicable. Evaluates and re-designs new methods, equipment and technology related to aseptic processing and environmental monitoring for the Microbiology Laboratory and manufacturing areas based on a scientifically sound approach (this evaluation must include\: area performance and cycle time efficiency, cost and HOT. Coordinates special projects to assure successful and timely execution, issuance and updating of detailed time and event schedules. Provides expertise and in depth analysis to ongoing operations (Manufacturing and Laboratory) so that facilities and procedures are continuously improved to assure the appropriate cGMPs are in place through operations audits. Supports actively the investigation process in the Microbiology laboratory from a quality and scientific perspective. Provides scientifically input. Performs EM/Utilities/gases trend analysis to provide recommendations in order to improve the process and /or the product quality. Supports the transfer and optimization of microbiological methods, equipment and technology for the Microbiology Laboratory related to EM, aseptic progressing and, Media Fills. Provides support, if necessary, to the analysis of raw material, in process and finished good samples, culture media preparation, stock culture maintenance, microbial identification and laboratory housekeeping/cleaning. Approves and recommends the necessary Capital Appropriation Request (CARs) and controls the purchase of materials, reagents, culture media and sophisticated systems and instruments for all microbiology analyses. Prepares and maintains the budget for the microbiology section with the appropriate support from subordinates and within established guidelines. Interviews, evaluates and selects qualified personnel in compliance with EEO/AA regulations. Enforces Environmental Health and Safety Programs in compliance with Bristol-Myers Squibb Co., Safety Policies, cGMP, GLP, OSHA and Regulatory Agencies as FDA, UK, TESD and others. Participates in Regulatory inspections and ensures compliance with the marketing authorization requirements. Assures that all departments have knowledge regarding the roles, responsibilities and authority of the Microbiology Unit.Requirements vary based on degree held. If candidate has a BS Degree in Biology, Biotechnology, Microbiology or Industrial Microbiology with eight (8) years of experience in a supervisory/managerial position, with at least five (5) years of experience in Parenteral Pharmaceutical Industry and two (2) years of experience in Clean Room, Aseptic Processing and Media Fill/Air Pattern Simulations, development and validation of microbiology methods and laboratory equipment. If candidate has a Master’s Degree in Sciences\: Five (5) years of experience in a supervisory/managerial position , with at least three (3) years of experience in Parenteral pharmaceutical industry and one year (1) of experience in Clean Room, Aseptic Processing and Media Fill/Air Pattern Simulations, development and validation microbiology methods and laboratory equipment. If candidate has a PhD Degree in Sciences\: Five (5) years of experience in a supervisory/managerial position with at least one (1) year of experience in Parenteral pharmaceutical industry and one year (1) of experience in Clean Room, Aseptic Processing and Media Fill/Air Pattern Simulations, microbiology equipment’s and methods validations. Self-motivated, creative and team work oriented. Technical knowledge in parenteral products, environmental monitoring program, aseptic fill operations, isolators, sanitation and sterilization process and smoke profiles. Must have knowledge in compendium requirements, cGMP, GLP, FDA and EU regulations and the ability to interpret and apply them. Fully bilingual (Spanish/English) communication skills, both written and verbal. Excellent technical writing skills (English/Spanish). Leadership skills, time management, planning and organization capabilities. Project management skills and self-starter. Knowledge of experimental design. Knowledge of PCs (Word, Excel, Power Point) and in general microbiology laboratory instrumentation such as incubators, sterilizers, oven, scales, pH meters, air samplers, microscopes, Biohazard and laminar Hoods, and Microorganisms Identification equipment. Proficient knowledge of problem solving skills and root cause analysis methodologies (i.e. Kepner Tregoe). Strong sense of urgency. In depth Analytical and critical thinking skills. Judgment and decision making skills. Excellent communication skills (English and Spanish). Solid technical writing related to investigations reports. Knowledge in environmental, health and safety matters as it relates to the site operation. Knowledge and experience on manufacturing and sterility isolators. Excellent interpersonal skills and the ability to interact with people at all levels. Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results. Willing to work irregular hours, rotating shifts, weekends and holidays when needed.