Perform the inspection and packaging of all finished goods in accordance to establish procedures and specification according to Good Manufacturing Practices, Safety and Standard Operating Procedures. Responsibility includes the inspection/packaging documentation (electronic and/or manual), and cleaning of area. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Operates automatic and/or semi-automatic inspection equipment following all established cGMP’s and Safety regulation maintaining equipments up time and running to reduce downtime to a minimum. Performed manual and semi-automated inspection for liquid and lyophilized products, including syringes.
Operates automatic and semi-automatic packaging equipment following all established cGMP’s and Safety regulation maintaining equipments up time and running to reduce downtime to a minimum. Performed manual and semi-automated packaging and syringes combination products assembly process, when necessary.
Cleans all packaging/assembly/inspection lines according to procedures, as needed.
Verifies components against the packaging process order.
Completes area accurate (error free) documentation required before line star up and during the packaging process, following good documentation practices and delivers it on time.
Performs housekeeping and handling of waste according to procedure.
Inspects the quality and accuracy of all data printed during the inspection/assembly/packaging processes.
Detects discrepancies during the packaging process, performs reworks/re-inspection as required by procedures.
Attends to all mandatory training meetings for cGMPs, EHS and company policies.
Participates in special projects and during audits and regulatory inspection and assists manufacturing activities in other areas within operations, as required.
High School Diploma
At least One (1) year of experience within pharmaceutical industry
Knowledge in operating the following inspection/assembling/packaging equipments:
Tendrá a cargo las actividades de difusión/promoción de nuestros productos, Línea Oncología. Identificará su grupo objetivo de médicos y hará presentaciones de los productos a los médicos referentes de la patología. Asegurará el cumplimiento de objetivos de venta y posicionamiento. Relevará constantemente información de mercado para identificar oportunidades. Será un nexo para el funcionamiento del Programa de soporte a pacientes, trabajará alineado y en contacto directo con Acceso, Marketing, Medical y demás representantes de la línea Oncología. Elaborará informes de gestión, definirá acciones.
El enfoque de la posición hace indispensable acreditar una experiencia previa de por lo menos 3 años en funciones de promoción y/o venta, en áreas de productos biológicos o equipos especiales (EXCLUYENTE). Se evaluará muy favorablemente poseer estudios terciarios y/o universitarios completos o en curso en carreras afines. Conocimientos de idioma Inglés (NO excluyente). Entendimiento del negocio Farmacéutico y de los Sistemas de Salud. Muy buen manejo de herramientas informáticas Es requisito residir en Provincia de Tucumán, contar con Matrícula Profesional de Agente de Propaganda Médica. Dedicación full time.
The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling activities. The candidate will be expected to effectively collaborate with colleagues in the Discovery Oncology, immunology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams and key stakeholders.
A B.S. with a minimum of 7 years, or an M.S. with a minimum of 5 years of industrial experience with strong scientific knowledge and research experience in in vivo pharmacology, cancer biology, immuno-oncology, or immunology is highly desirable.
Extensive knowledge of preclinical drug development including demonstrated knowledge of independently designing, executing, and analyzing data from in vivo studies with tumor bearing mice is required.
Experience with syngeneic tumor models is preferred; experience with GEMMs is a plus.
Required skills include: tumor model development, tumor implantation, animal identification and randomization, dosing via IV, IP, SC, I-TUMOR and PO routes, tumor measurements by caliper, blood draws by tail vessel micro-sampling, cardiac puncture and tissue/tumor collection at necropsy including fixation, freezing and tissue disaggregation to support ex vivo analyses.
Experience utilizing multi-color FACS to characterize tumor infiltrating lymphocytes is desirable.
Proficiency in cell culture and ex vivo techniques such as qPCR, ELISA (MSD), or WB is required.
Experience with surgical procedures to enable development of orthotopic tumor models and using ultrasound to monitor orthotopic tumor growth is desirable.
Experience conducting in vivo pooled genetic screens is desirable.
Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required.
Ability to mentor junior scientists and colleagues on best practices in the laboratory would be highly valued.
Attention to detail with excellent organizational and record keeping skills is a requirement.
Ability to thrive as a member of a diverse and motivated team of researchers spanning across the Oncology Discovery group is a requirement.
Independently design and conduct mouse in vivo pharmacology experiments, including but not limited to model development, tumor implantation, animal identification and randomization, dosing via IV, IP, SC, I-TUMOR and PO routes, tumor measurements by caliper, weighing, health monitoring, tissue sampling by fine needle biopsy and core needle biopsy, peritoneal lavage, blood draws by retro-orbital, tail vessel micro-sampling, cardiac puncture and tissue/tumor collection at necropsy including fixation, freezing and tissue disaggregation to support ex vivo analyses.
Mentor junior associates on best practices (in vivo and ex vivo).
Establish complex orthotopic tumor models.
Utilize ELISAs (MSD), qPCR, or WB to monitor biomarkers in harvested tissues.
Contribute to the utilization of multi-color flow cytometry to profile the immune infiltrate in harvested mouse tissues.
Accurately maintain proper scientific documentation associated with pharmacology studies in an electronic lab notebook.
Effectively communicate and present summaries of research results to team members or to a multidisciplinary team of researchers.
Work as a member of a diverse and motivated team of researchers spanning across the Oncology Discovery group and other line functions.
Rotating weekend, holiday and off-hour on-site responsibilities to support BID/QD dosing will be expected of this position.
This position is located in Cambridge, MA. There will be less than 10% travel.
The goal of pharmaceutical development within Research & Development is to develop new drug candidates and the processes to manufacture them into commercial realities. This Is achieved by designing and conducting a variety of experimental studies using the latest scientific methods and state of the art equipment and instrumentation. The development process is very dynamic with studies performed in both laboratory and process scale-up facilities. Scientific rigor, timeliness and compliance with all GLP and federal/state/local regulations are a necessity.
In order for the development process to be successful, there must be excellent collaboration between the professional staff/scientist and union staffs. Often, the professional staff/scientist will need to take a hands on approach during the course of testing as necessary based on sound scientific judgment. Involvement of union staff In the various experimental studies and other processes Is determined by the professional staff/scientists on a case by case basis because of the non-routine, dynamic nature of the development process.
Work assignments will be based on demonstrated technical competence of the individual technician and the demands of the process. Priorities will be set based on the needs of the R&D business. Both written procedures and verbal instructions by a supervisor will be executed with strict attention to safety and quality. Accurate and timely execution and documentation of activities and results are a requirement.Strict adherence to cGLP/GMP, federal, state and local regulationsIs required. In order to achieve departmental and company goals, collaborative work with other employees (both professional and union) is a requirement. Evaluation of Individual performance as compared to job function and BMS core behaviors will be evaluated throughout the year.
Bachelors' degree with a major in biology, or an allied science and coursework inmicrobiology from an accredited college or university. Must have a minimum of 1 year experience In pharmaceutical microbiology, especially In parenteral and/or aseptic operations. Proficiency in use of computer programs/systems Is essential. Bacteriologists must maintaintheir skills and knowledge to stay current with advances In the field of microbiology. Bacteriologists may attend internal or external training courses as approved by management.
Laboratory skills training will be implemented to ensure employees receiverelevanttraining to facilitate the performance of their job responsibilities. Interactive training modules (I.e. On-The-Job Training) will be used for training on specific competencies. Competency check after trainingspecific to an area will be conducted to evaluate proficiency of the new skill (or module). If required proficiency is not obtained the interactive learning and testing will be repeated. A pass/repeat summary of all testing on each module will be kept to assess the performance of the module. Bacteriologists will be required to demonstrate competence after training as assessed by their management. In the event competence is not demonstrated, re-training will be provided. Required refresher training including laboratory safety and compliance must be kept up to date.
The position will require the employee to work withchemical, radiological and biological agents that may be hazardous to health If mishandled (including agents which may potentially affect the development of a fetus). Assignments will be executed in laboratories. Employee will be required to follow all safety procedures and use personal protective clothing/equipment as provided by the company where specified. Disagreeable conditions including odors, heat, noise, etc. may be experienced. Some projects will require working in high containment areas using established handling procedures.
Performs microbiological testing to ensure that the proper standards of quality are maintained. Performs microbiological, bacterial endotoxin, total organic carbon and conductivity analyses of water system samples. Performs environmental monitoring and water sampling in support of the routine operations and manufacturing. Demonstrates the use of aseptic technique. Analyzes, develops and recommends new methods for the improvement of various standard assays and tests. Carries out analytical tests and inspections in connection with the investigation of product and environmental monitoring excursions. Evaluates results and submits documentation for approval. Performs routine maintenance and calibration procedures on laboratory instrumentation. Troubleshoots equipment and methods for investigational purposes. Performs laboratory support activities such as stock culture maintenance and laboratory Inspections, as assigned.
Responsibilities Include maintaining laboratory documentation, samples, and equipment under strict compliance with safely, GMP, federal, state and local regulations. Maintains laboratory notebook (paper or electronic}, record/capture records raw data, calculates results and submit results to laboratory supervisor and/or computer database following Good Documentation Practices. Responsible for reporting to supervisor any anomalies or irregularities that may occur during the performance of any and all assigned assays. Prepares, updates or assists In the revision of SOP's, training documentation and departmental forms to reflect current laboratory practices. Cross-trains to ensure full functionality on all laboratory equipment and methods. Trains other employees in the analytical techniques, SOP's, GMP's, administrative and safety procedures In the laboratory as required.
The Lead Human Resources, Puerto Rico - GPS Operations has responsibility over all GPS operations across Puerto Rico as well as integration of HR policies and strategies across the island and all BMS organizations. The scope includes the Biologics drug product site in Manati (800 employees) and the small molecule site in Humacao (350 employees) responsibility as well as the statutory responsibility over the Commercial office in Guaynabo (30 employees). The leader of this team partners with the HR Lead, GPS Operations and has 2 HRBP respectively in Manati and Humacao and a Puerto Rico HR Coordinator reporting directly into this role.
Provides strategic HR Business Partner expertise to the site GMs & their respective teams in order to drive business performance and foster cooperation across the enterprise.
Leads a team of HRBPs dedicated to respective sites as well as the Puerto Rico HR Coordinator by articulating a clear vision, and ensuring the implementation and success of the People Strategy and the full implementation of the HR Operating Model.
Strategic and Consultative, and drives execution excellence through the People Services team
Leverages business strategy, people strategy, external best practices and organizational insights to deliver bold and innovative organizational and talent solutions.
Contributes actively to Operations talent plan with an enterprise lens.
Applies “systems thinking” and leads change for effectiveness of organization performance through the use of metrics and analytics in a way that drives business performance.
Applies judgment to data insights and trends to support business talent and organization decisions that drives organizational effectiveness and innovative and robust workforce planning , engagement strategies, and succession management
Collaborates across the HR OP Model (COE’s, People Services) to articulate business needs and partners in delivering solutions in ways that bring value across the enterprise; Accountable for the full implementation and stabilization of the HR Operating Model for both GPS sites, which includes establishing priorities with PS and CoE partners as well as leading the change with the sites leadership.
In charge of driving the plants WFP and organization efficiencies, including major shift in manufacturing processes in line with GPS network strategy. Defines and leads change management efforts to ensure delivery of organizational solutions, programs and deliverables
Establishes the People Strategy to support the Puerto Rico integrated campus approach, in close partnership with the island BMS leadership
Partners with the US Commercial HR team to provide appropriate support to the Commercial office and GM
Takes a leadership role in creating a respectful and inclusive work environment while role-modeling the BMS Behaviors and fostering cultural diversity.
Represents BMS with external environment in Puerto Rico and establish a proper branding strategy with key external stakeholders incl. schools, colleges and local communities.
Responsável pelo planejamento de marketing dos produtos e por contribuir para a implementação deste planejamento em parceria com as áreas de vendas e médica. Aplicando seu conhecimento para o desenvolvimento do time, buscando atingir os objetivos do budget e fazendo a gestão das despesas do departamento de marketing.
Desenvolver o planejamento de marketing dos produtos utilizando as informações disponíveis e consultando a equipe de vendas, médica e BI além do marketing internacional;
Contribuir para a correta implementação da estratégia de marketing, em parceria com a equipe de vendas e médica, visando atingir os objetivos do budget
Garantir o entendimento da mensagem estratégica e a sua implementação através da ferramenta do value selling
Fazer a gestão das despesas alocadas no departamento de marketing
Desenvolver e produzir, controlando os terceiros envolvidos, os materiais promocionais e institucionais que serão utilizados pela BMS para atingir os objetivos da marca e budget
Desenvolver ou adquirir estudos de demanda atual e futura, acompanhar os dados em parceria com a área de business intelligence e gerenciar os excessos de inventário e falta de produtos
Desenvolver relacionamentos de trabalho produtivos com os principais líderes de opinião da área no Brasil objetivando o entendimento da entrega das mensagens estratégicas
Agir em parceria com a área de treinamento e de vendas objetivando o treinamento e preparação adequados do time de vendas;
Monitorar os competidores, analisando as informações de mercado, de tal modo a corrigir ou confirmar a estratégia e ações táticas dos produtos da área;
Garantir o gerenciamento das pesquisas de mercado e medir adequadamente a participação do marketing share dos produtos BMS na sua indicação
Garantir a regionalização da estratégia definida pelo time Global de acordo com as necessidades do mercado local;
Liderar o Local Brand Team no desenvolvimento de iniciativas para garantir os resultados da marca, em linha com os comportamentos da BMS e espírito de In Field Brand Team
Responsável em buscar novas oportunidades de negócio para o produto através da inovação contínua;
Garantir que ações estejam 100% Compliance, incluindo contratos com instituições e relações com Health Care Professionals
Responsável pelo desenvolvimento da assistente de marketing ou estagiária através do estabelecimento de um plano desenvolvimento de carreira
Bristol-Myers Squibb (BMS) is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Ireland, Cruiserath, Dublin 15, approximately a $1 billion investment. The new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.
BMS Cruiserath Biologics is seeking to recruit a QC Bioanalytical Laboratory Senior Analyst on a fixed-term contract, reporting to the Bioassay laboratory manager. The BioAnalytical Senior Analyst will be responsible for the scheduling, final review and reconciliation of testing in the BioAnalytical laboratory in addition to the supporting the running of the BioAnalytical laboratory by performing analytical methods and providing training to team members. The BioAnalytical laboratory function includes all assays as assigned including but not limited to the BioAnalytical laboratory.
Key responsibilities will include, but not limited to:
Supervise project work for members of the BioAnalytical laboratory.
Review BioAnalytical laboratory generated data to ensure that all results meet the integrity and expectations of a GMP laboratory.
Review or write technical documents pertaining to analysis performed in the BioAnalytical laboratory.
Perform laboratory duties in accordance with cGMP regulations and departmental procedures.
Generation and review of documentation as assigned to support equipment and instrument validation.
Generation and review of SOP’s, WI’s and associated documentation as assigned to support establishment of GMP Laboratory Operations.
Ensure all analytical paperwork is completed to the required standard and in compliance with local procedures.
Ensure logbooks are maintained and reviewed where required.
Ensure laboratory is always maintained in an inspection-ready state.
Complete the review of analytical paperwork and associated logbooks to ensure testing has been completed in compliance with procedures
Identify and investigate any out of trends or adverse trends present in analytical results.
Liaise with QCTS/technical specialist to obtain technical support with instrumentation/analytical methodology.
Liaise with QCTS/technical specialist to obtain compliance support with laboratory investigations/quality events or related issues.
Work closely with the QC management /technical specialist and QA to raise and closeout laboratory investigations/quality events in a timely manner and complete a thorough investigation.
Work closely with the QC management/technical specialist and QA to identify appropriate corrective and preventative actions.
Complete additional testing when required to support investigations/validations.
Ensure laboratory equipment is correctly maintained. When unplanned instrument maintenance is required or instrumentation issues arise, inform QC Technical Services
Ensure training is completed before execution of a task.
Ensure adequate stock of laboratory reagents.
It is the responsibility of the BioAnalytical Senior Analyst analyst to strictly adhere to procedures and ensure any issues identified are raised immediately.
Attend periodic team meetings and participate in a culture which is committed to high performance, innovation and promotes idea sharing
Meet with the QC Bioassay laboratory manager to discuss performance provide feedback and identify any development opportunities
Where identified as a subject matter expert, provide peers with ongoing coaching throughout the year in instrumentation and analytical methodology.
Where identified as a subject matter expert, provide training to new employees or peers
Complete the performance connections process
Lead the BioAnalytical group change controls and investigations.
Ensure a safe work environment for oneself and all employees
Ensure all near misses and incidents are reported
Ensure waste generated as a result of routine and non-routine activites is disposed of as per local procedures
Ensure high standards of GMP and house-keeping are maintained in the laboratory
Generation and review of SOPs and work instructions
Completion of training in accordance with company training plan
Execute additional instrument, product and laboratory operational tasks assigned in objectives.
The job holder should demonstrate the following Competences:
Core competencies such as teamwork, communication skills, technical writing skills.
Strong technical background in biochemistry, or related discipline
Ability to work to tight timelines
Openness to change, receptive to new ideas
Good communication skills
Good Troubleshooting skills
Knowledge of FDA and European GMP’s, particularly pertaining to laboratory operations.
Required Qualification(s) and Desired Experience:
Minimum of a BSc. in Biochemistry or related discipline
Minimum 5 years working in a pharmaceutical environment
Experience working as part of a team.
Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level. The BMS Behaviours are: Passion, Innovation, Accountability and Speed.
Why should you apply:
You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days,life assurance and gain-sharing bonus.
Join us and make a difference
At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Clinical Site Manager leads the cross-functional Hub project team, is responsible for the overall project management of the study at the Hub/country level, manages all site-related issues and ensures the protocol is executed appropriately, meeting timelines and targets.