Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
ISR Protocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will provide operational expertise and will focus on studies including Investigator Sponsored Research & other study types. Protocol managers act as a matrix leader for operational support team(s) and are accountable for the timely execution of NRDG trials.
Desired: Strong experience in the cardiovascular/oncology/immunoscience therapeutic areas and experience with managing these studies.
Manages complex and varied study types across a matrix organization.
Familiar with clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality, timelines and budget are managed according to expectations.
Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving within team’s control. Applies critical thinking to manage complex issues. Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.
Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables. Creates synergy with stakeholders and develops strong alliances and teamwork with Medical, Operational leadership, field medical, drug supply, and other team members. Effectively leverages network of internal and external contacts.
Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process. Strong understanding of GCPs, ICH and regulatory guidelines as they apply to protocol management and program strategy.
Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
Minimum education BA/BS required.
Prefer individual with strong science background with a minimum of 5 years of demonstrated complex trial management experience in the pharmaceutical or CRO (or equivalent) industry
Prefer individual with a minimum of 5 years of demonstrated NRDG (ISR) experience
The primary role of the downstream Purification Process Operator is following detailed procedures and batch records insuring compliance with CGMP and safety requirements. The Process Operator works on assignments that is moderately complex in nature, where judgment is required in resolving problems and making routine recommendations. Work is performed in a team environment within a medium-scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). Additional gowning through the processing areas and maintaining clean hygiene is a requirement to control established environmental specifications.
Duties/Responsibilities: The Process Operator
• Operates control systems and processes supporting biotechnology downstream Purification manufacturing.
• Maintains files, records data, logs activities, and monitors processes.
• Prepares process buffers and reagents.
• Cleans and Steam sterilizes equipment and maintains area in a clean and orderly fashion to support the manufacturing schedule.
• Recognizes and reports safety, maintenance and quality events to area management.
• Communicates status of operations to area management in a timely manner.
• Achieves and maintains proficiency through training.
Specific Knowledge, Skills, Abilities:
Prior job related experience required along with demonstrated mechanical aptitude. Familiarity with general chemistry, mathematics, microbiology and cGMP operations is a plus. The nature of the position demands a high level of attention to detail. Prior experience following and documenting written instructions is required. The successful candidate will be a committed team player prepared to work in and embrace a team based culture. Rotating shift work, weekends, holidays and overtime required. The selected candidate will possess excellent written and verbal skills to communicate expectations and results to the operating staff and management as needed to maintain production timelines and organizational goals.
The successful candidate will have a high school diploma with a minimum of 1-3 years process operations experience; A.A.S. or B.S. degree is preferred.
The Process Operator Position requires frequent dexterity movements such as walking, bending and reaching with repetitive hand movements to operate valves, hoses, piping and process control systems.
The Process Operator Position is primarily inside work which may require working within teams as well as working alone. Chemical handling and the ability to wear personal protective equipment is a requirement of the position
This posting is for a 12 hour night shift position.
This position is for Eliquis, Specialty Retail Sales Representative located in Charlottesville, VA
Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines. Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals.
An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum. Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time. Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers. Excellent communication skills- verbal and written- including the ability to present to groups.
Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners. Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types.
Possess a high level of ethics and integrity. Adhere to all applicable laws, regulations, and BMS policies.
Bachelor's degree or equivalent is required. Minimum of 5 years of sales experience is preferred. Demonstrated success in medical profession is advantageous.
A strong customer focus and analytical skills to identify and prioritize business opportunities is required. Proven track record in delivering results and developing innovative approaches in evolving markets. Previous new product or concept launch experience desired. Ability to learn, apply, and grow disease state knowledge is required. Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings. Technical aptitude to learn and apply new technologies to manage a territory is required.
Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate. In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies: Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning.
As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.
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 permanent Quality Assurance Specialist (QA Operations), reporting to the Qualified Person the Quality Assurance Specialist will support the batch certification process for finished drug product.
Key responsibilities will include:
Support the Qualified Person with the Batch Certification function
Prepare and review batch documentation packages for QP release as per SOP requirements
Liaise with BMS Supply Chain and Quality colleagues to ensure that disposition lead times are consistently met
Update SOPs, controlled documents i.e. FORMS and OTJs
Assist in new product introduction activities as required
Provide training to new team members
Support the site inspection readiness program for corporate and regulatory inspections
Identify and make recommendations for improvements to ensure continuous improvement
Participate in site activities associated with the QMS (e.g. Change Control, Self-Inspections, Quality Agreement updates, Customer Complaints, Product Quality Record Reviews) as required
Ensure that all work carried out follows the required standards conforming to SOPs, regulatory regulations and guidelines, and Quality Agreements
Perform additional team tasks as agreed to support effective running of the function
Qualifications and Experience required:
A degree in science, engineering or related discipline is essential. A minimum of 1-2 years’ experience in pharmaceutical /biopharmaceutical industry
Experience using data or electronic document management systems (DCA, Trackwise, LIMS, SAP)
Strong working knowledge of Microsoft Excel and PowerPoint
Ability to work on his/her own initiative in addition to working as part of a team
Good organizational skills and attention to detail
Ability to handle multiple assignments and changing priorities
Ability to learn and utilize computerised systems for daily performance of tasks
Ability to prioritise, manage multiple tasks, and meet deadlines
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.
Act as liaison between the different functions (Drug Supply Planning, Clinical, Medical Development Operations (MDO), Global Regulatory Science (GRS), quality teams, vendors, etc.) and serve as central point of contact for drug order shipment requests. Ensuring timely processing of IMP drug shipment orders, troubleshooting, issue resolution and clinical site support as necessary.
Key Responsibilities and Major Duties:
Ensure regulatory requirements are met as required prior to IMP shipment delivery to customers.
Create, organize, and coordinate IMP shipments to sites, including sample shipments, compounding material requests, and 3rd party shipments. Ensure accurate and timely delivery to warehouses and investigator sites as outlined in Drug Provisioning Plan, and as initiated via individual site order request (both IRT and manually generated order).
Troubleshoot and coordinate resolution of IRT to SAP order failures with urgency to ensure drug availability at the site in time for patient treatment.
Resolve and address drug delivery issues ensuring accurate and timely delivery to final delivery address (BMS sites, investigator sites, 3rd party warehouses).
Guarantee logistical requirements i.e. Green Light, provision of required documentation such as Import Permits, certificates, and accurate invoice, etc are met.
Ensure timely SAP Goods Issue, pro-active delivery tracking, entry of SAP POD for non-IRT studies, SAP Goods Receipt entry, and adequate follow up till unblocking of supplies, timely communication with IMP distribution planning and quality teams as applicable.
Collaborate with temperature profiling colleagues to obtain assessment for temperature excursions and provide usage decisions to sites or warehouses in a timely manner.
Promptly communicate critical drug availability issues to the IMP distribution planning teams.
Initiate, complete and close Incident Reports with transporters and distribution sites ensuring investigation completion.
Initiate, follow up and close NTR’s, Quality Events, Investigations and CAPA’s (Trackwise) within company timelines.
Ensure redeployment shipments are handled adequately (export & import) as well as special returns for quality investigation.
Handle appropriate delivery deletion and update of related systems (IRT, SAP).
Ensure coordination and proper execution of field transfers, in collaboration with the representative Clinical team, IRT vendor, GQRC, DPP and carrier.
Monitor the stock of empty credo boxes and organize international returns.
Consult applicable transport & packaging guidelines or get advice from related SMEs i.e. transportation/ TPA to guarantee optimal protection of sensitive IMPs during transit.
Consult transportation SME for anything related to customs, brokerage, payments of vendor invoices, import/export processes.
Provides business support to the global R&D Logistics function and CSO Moreton.
Scope of responsibilities includes vendor order management, budget tracking, financial data analysis and reporting, business metrics development and reporting, ownership of a range of business tools supporting global logistics operations.The role liaises with a wide variety of functions and levels within and outside BMS to provide business support for the function.
-Web page owner for R&D logistics; develops and promotes communication tools to drive business efficiencies.
-Acts as system Administrator for R&D Logistics training assignments and role-based curricula.
- Acts as system Administrator for R&D Logistics procedural document management
-Maintains a range of business metrics and tracking tools; develops and implements reporting tools to meet business requirements.
-Controls vendor orders and requisitions for the R&D Logistics organization. Monitors purchase order limits and ensures update and renewal as required.
-Supports, in collaboration with OPS specialist, legal and financial reporting requirements, working across a range of internal functions.
-Verifies invoicing against service agreements and approves payments in compliance with applicable corporate policies. Provides input into monthly accruals process.
-Liaises with vendors and Global Procurement to resolve payment issues, vendor master file discrepancies.
-Control of mailgroups supporting R&D logistics process – both internal and with third-party providers.
-Supports maintenance of GMP documentation retention processes at BMS Moreton.
-General administrative support, including but not limited to, travel and meeting arrangements, expense processing, preparation of presentations, office supplies and material ordering.
-Bachelor’s degree in relevant field (business administration, supply chain, logistics) with significant experience in a business support function, preferably within a pharmaceutical or logistics environment.
-Strong IT skill base with experience in data handling and analysis and with a good working knowledge of SAP.
-Must be proficient in a range of Microsoft tools, including Excel, Word, Powerpoint, OneDrive, One Note, Sharepoint online
-Familiarity with analysing and reporting financial data
-Strong organizational skills. Demonstrated ability to manage multiple projects simultaneously and to complete assigned projects independently.
-Strong interpersonal communication skills and ability to build strong relationships and networks. Demonstrates a persistent, pro-active, flexible, and team oriented work ethic.
-Experience of working across a range of stakeholder groups and organisational levels to resolve problems
-Excellent communication skills, including fluency in verbal and written English.
-Customer-focused, stress resilient; quality and detail oriented.
Als Mitarbeiter im Außendienst (m/w/divers) mit Schwerpunkt im Gebiet (Bensheim, Heppenheim, Seeheim, Riedstadt, Bürstadt, Worms) sind Sie verantwortlich für den Verkauf unserer innovativen kardiologischen Produkte.
Sie beherrschen moderne Verkaufstechniken und betreuen und beraten Hausärzte und niedergelassene Fachärzten. Sie konzipieren selbstständig Vertriebspläne und innovative Veranstaltungskonzepte für Ihr Gebiet und setzen diese zuverlässig um. Sie beobachten und analysieren den Markt und reagieren umgehend durch die Anpassung Ihres Gebietsvertriebsplanes. Sie sind geübt im Umgang mit modernen Analysemethoden des Außendienstes und entwickeln sich gerne weiter. Zudem sind Sie für die Organisation, Einladung und Durchführung von regionalen Fortbildungsveranstaltungen in Ihrem Gebiet verantwortlich. Auch übernehmen Sie gegebenenfalls Standdienst und Kundenbetreuungen auf nationalen Fortbildungsveranstaltungen und Kongressen.
Sie sind Pharmaberater/in gemäß § 75 AMG und haben idealerweise ein naturwissenschaftliches Studium abgeschlossen oder Sie sind Geprüfte/r Pharmareferent/in; ein betriebswirtschaftliches Studium ist von Vorteil. Zudem verfügen Sie idealerweise über gute Englischkenntnisse, sehr gute PC-Kenntnisse runden Ihr Profil ab. Sie nutzen Ihr kommunikatives Talent, denken konstruktiv und strategisch, um neue Kundenkontakte aufzubauen und bestehende Geschäftsbeziehungen zu vertiefen. Mit Ihrer gut organisierten, eigenverantwortlichen und teamorientierten Arbeitsweise überzeugen Sie Ihre Geschäftspartner und tragen damit zur Erreichung der gemeinsamen Ziele innerhalb der Region bei. Der Umgang mit modernen Kommunikationstechnologien ist für Sie selbstverständlich. Räumliche Mobilität und Flexibilität sowie das Potenzial und die Bereitschaft zur Übernahme zukünftiger Führungsaufgaben im Marketing und/oder Vertrieb komplettieren idealerweise Ihr Profil.
1.Supervise operators to produce qualified pharmaceutical products in accordance with GMP, EHS and other regulatory regulations, accomplish the production assignment on time; Responsible for work on documentations(including SOP, batch record and data analysis etc); Give training to workers; Timely take correct actions to the abnormal issues in production.