Accountable for performing and reviewing chemical and physical testing of materials and products (small molecules & large molecules) in accordance with BMS procedures and specifications and/or applicable compendia. This position must comply with all security guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function.
Performs testing for raw materials, packaging components, intermediate products, finished products, and ILQ’s as per current monograph/testing methods, USP, NF, proposed monograph or validation protocols (where applicable).
Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.) and verifies data generated by other peers.
Evaluates and analyzes data to identify and understand quality performance trends.
Ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas.
Performs laboratory equipment daily calibrations, verifications, qualification, validation and troubleshooting.
Maintains accurate records of all work performed and document testing results as per Good Documentation Practices and of all laboratory notebooks and worksheets as per QC SOP’s.
Participates in process validation, laboratory equipment qualification, and analytical method transfers.
Recommends change to SOP’s, protocols, monographs, etc.
Provides support in the investigations of non-conforming results and resolution of investigations.
Assists in new laboratory personnel in training when required.
Follows laboratory SOPs for sample handling and the proper management of data generated.
Participates in Company projects and programs, such as safety and environmental training, GMP’s, SOP’s and others as required.
Purchases and maintains inventory of required supplies (e.g., standards, reagents, etc.).
Conducts internal audits (e.g., laboratory facilities, reference standard, reagents and product log book audits, etc.).
Ensures that use approved validated methods and specifications, to perform required testing when is involved in testing of finished products, API’s, biological drug substances, raw materials, intermediates / components and ensures all necessary testing is carried out.
Ensures that the QC equipment that will use and that he/she are formally qualified before release testing of products/materials is performed.
Ensures that stability studies testing follow specific protocols and procedures.
Verifies that Laboratory procedures and specifications are consistency with other site procedures and/or specifications and; that are in compliance with BMS Policies and Guidelines.
Completes all required testing on time dictated by SAP and area cycle time requirements in compliance with company and regulatory requirements.
B.S. degree in Science with a major in Chemistry, Biochemistry, Industrial Chemistry, Biology or Medical Technology
One (1) year of experience in a Pharmaceutical environment
Working knowledge of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc)
Knowledge on analytical data collection and documentation or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.)
Knowledge of laboratory equipment, such as: UV-Visible, FTIR, HPLC, GC, CE, Scanners, micro plate readers
Ability to perform basic troubleshooting, PM and/or calibration of laboratory equipment (column care and use, tools, in-line filters, etc.)
Ability to conduct a variety of analytical techniques
Knowledge of site safety, security and environmental requirements (e.g. MSDS, safety inspection checklists, waste disposal, etc.)
In-depth knowledge in the use and interpretation of USP/NF
Basic knowledge and experience with QC SOP’s, cGMP’s, federal and other countries regulatory requirements, documentation procedures and company policies/procedures
Working knowledge of statistical techniques.
Ability to work in a teamwork environment
Ability to plan work schedules and set priorities with urgency and meet deadlines within a complex, rapidly changing environment
Proficiency in oral and written communication skills in both, English and Spanish
Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary
The Oncology Medical Lead is an instrumental role within the Oncology franchise responsible for managing and leading a team of Disease Area Specialists. The Lead will support the professional development of their reports, ensure that robust Medical Affairs plans are developed and executed on time, on budget, and to strategy, and foster true partnership between external and internal stakeholders.
With the challenge and reward of responsibility for multi-indication products and a very rich pipeline in Oncology, the Lead will help the team navigate skilfully and proactively to strive for success for our business and, above all, for our patients.
Medical Affairs is a dynamic profession involving interaction with a large number of internal cross-functional teams and external stakeholders. No two days are the same, and the role demands a flexible and proactive individual with a strategic mind and sound judgement to support these diverse needs. A strong collaboration is formed within a matrix team due to a solution-finding mind-set, to drive the goals of the business and improved patient outcomes in an ethical, compliant way.
The Medical Lead will not only demonstrate this personally, but will support a team with enthusiasm, drive, and accountability to unlock individual development potential and collective performance. This role will involve developing, coaching, and building a team into a cohesive, high performing unit, demonstrating excellence across the Medical Affairs pillars such as thought leader engagement, scientific exchange, medical education, and Medical leadership with internal stakeholders.
The Medical Lead will have a strategic role, anticipating the future needs of the business, and fostering and driving innovative solutions with their reports and the wider matrix organisation.
Lead, coach and develop reports to grow and excel in Medical Affairs skills and behaviours
Co-Lead local tumour cluster oncology team with Marketing and provide input into the company strategy for allocated therapy areas
Manage the development and delivery of medical strategies and non-promotional activities through Disease Area Specialists and the field medical team, aligned to company and country needs, and support the Commercial team with the development of promotional material
Drive development and execution of Medical plans for relevant therapy areas with budget accountability
Maintain strong scientific relationships with health care professionals and co-ordinate appropriate insights sharing with relevant internal stakeholders
Coach the team to drive full compliance with the UK Code of Practice and local company policies and procedures; Medical Signatory work as required
Self-motivated and proactive
Works for the benefit of the team and business
High personal accountability and strong sense of purpose
Strategic thinking, solution-orientated
Skilful prioritisation with ability to change course at short notice and support team to do the same
Enthusiastic, motivating, supportive to direct reports and matrix team
Passion for the value Medical Affairs can bring to the business and for the science of our products
High personal integrity with a strong motivation to ensure compliant and ethical activities for the business
Inclusive: integrates diversity and differences in skills and outlook to get the best out of their reports and team
Knowledge & Skills:
Trained in the UK Code of Practice to level of a signatory with deep practical insight in UK compliance
Deep scientific understanding
Matrix team leadership
Excellence in communication and presentation skills; fluent English
Coaching and mentorship skills
Rich insight into the evolving UK health care environment and understanding of the principles of market access
Understanding of core Company policies and procedures
Willingness/ability to travel– (approximately ~15% travel nationally/internationally to attend external congresses, internal conferences and HCP engagement activities)
People management experience
Strong knowledge of oncology/haemato-oncology
Advanced scientific or clinical degree
A registered physician or UK registered pharmacist is preferred. Exceptional candidates with a scientific background with experience and Code knowledge are welcomed
Substantial Medical Affairs experience, preferably in a large market and preferably in Oncology, ideally as a final signatory
Significant experience in the review and approval of promotional and non-promotional materials and an excellent understanding of the ABPI Code of Practice
Experience in effective working in a cross-functional and matrix team-structure
Track record in developing strategy
Track record in supporting the delivery of UK HTA submissions, medical projects, Affiliate studies
Experience in product launches
Experience with real world evidence and compassionate use programmes
Effective Thought Leader partnership and engagement
Clinical experience in Oncology or haemato-oncology
European/regional medical/project experience
This role exemplifies the future of Medical Affairs – innovative products, multi-indication medications, evolving scientific questions, increasing speed of Clinical Development for pipeline products that fill high unmet needs for patients. This is a fast-paced and dynamic environment internally and externally, with a truly collaborative and passionate team and company, fostering collective responsibility, innovation and agility to better serve our patients.
This opportunity will offer the successful candidate the opportunity to develop enhanced management skills and to gain extensive launch and project management experience. He/she will play an instrumental role enhancing the value of the pipeline-portfolio and driving the medical performance of the company’s key growth drivers and will gain thorough understanding of cross-functional and cross-regional processes.
The Director, Biomarkers Commercialization Lead, is a high profile marketing role responsible for driving market development activities and a successful launch of companion diagnostics (CDx) tests that support BMS’s best in class Immuno-Oncology drug pipeline. This role will focus on commercialization of next generation of genomic biomarkers with an execution focus on ex-US markets. This position will report to WW Biomarker Commercialization Lead and includes the following responsibilities:
Lead the development of global launch strategy and drive successful commercial execution of companion diagnostics for next generation genomics biomarkers.
Customize launch preparedness across ex-US markets; develop go-to market model to deliver broad access to testing and seamless integration into tumor strategies.
Develop initiatives and execute tactics to drive broad and rapid adoption of companion diagnostic tests.
Develop marketing message platforms, campaigns and collateral to support successful launch.
Establish partnerships with key BMS Oncology stakeholders. Collaborate closely with the medical, cross tumor and in-market teams on developing and executing launch plans.
Lead all commercial aspects of diagnostics programs with external partners to ensure flawless execution of pre-launch and launch plans.
BS/BA or equivalent required; an MBA or other advanced degree preferred
10 + years of experience, with at least 6 years in marketing is sought
Prior diagnostics experience required, either from Diagnostics industry, or in Pharma with the launch of an indication and its companion diagnostics
Contribute to the improvement of clinical data review and cleaning efficiency by providing innovative and forward thinking reporting solutions. Inspire new and creative ways to meet data review objectives. Serve as a liaison between Technical Leads and stakeholders including data management, clinical data reviewers, and physicians.
Identify opportunities for analytic support within the data review community. Interpret and translate business needs into tangible reporting solutions. Serve as liaison between Technical Specialists/Leads and user community. Drive the development and implementation of new reporting tools as applicable.
Key Responsibilities and Major Duties
Can interpret and translate a business data review need into a tangible report/visualization
Interface/liaise with end users and Technical Specialist/Lead
Collaborate with Technical Specialists/Leads to define feasible solutions or to understand technical limitations
Will contribute to discussions to define new opportunities for data review tools
Can translate requirements/specifications to programmers
Can think holistically about data review approaches that will support Risk Based Monitoring, clinical review and other data related initiatives
Will provide support and training to the user community regarding the use and implementation of new reports/visualizations, including the development of any applicable training material
Can proactively identify data review gaps in current processes and projects
Can create/develop prototypes for new solutions as applicable
BA in Computer Sciences with 5 years of relevant experience
Strong analytic and problem solving skills
Proficient in the use of analytic tools, and SAS, Spotfire or SQL
Strong understanding of relational databases
Strong communication skills
Varied TA knowledge
Can think broadly regarding data review strategies
Experience interacting with Informatics on large scale projects
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.
• The successful candidate will report to the Executive Director who leads Discovery Toxicology and will provide administrative and project coordination support for a department of multidisciplinary scientists.
• The successful candidate will also support the Director for DPAS and his department of multidisciplinary scientists.
• Duties include but are not limited to completing independent project work, scheduling meetings, managing personnel data and transactions as proxy for supervisor, maintaining the department's SharePoint site, supporting recruiting efforts, supporting department projects and data tracking (weekly headcount, vacations, training records and curricula vitae for all personnel, monthly org charts, and SAP systems) calendar, phone, T&E, travel (domestic and international), office supply inventory and general purchasing support. • The successful candidate will also work with department scientists to ensure appropriate distribution and retention of research protocols, including administrative oversight for the organization of study record archives in accordance with departmental and corporate SOPs. • The position requires flexibility and willingness to provide administrative support for the two departments, to work on multiple tasks simultaneously and to balance priorities through utilization of strong organizational skills. • Short deadlines must be met with a high level of competency either through working independently or as a team member when required and by anticipating and creating contingency plans to ensure success. • As a member of the Pharmaceutical Candidate Optimization (PCO) administrative team, the candidate will provide interdepartmental and cross-site support of PCO functions on an as-needed basis.
Five to seven (5-7) years administrative or comparable experience with a minimum of 3 years experience as a senior administrative associate.
Knowledge of the pharmaceutical industry and familiarity with processes and infrastructure of a Research and Development organization is preferred, but not required.
Ability to work in a highly collaborative environment and must embrace and support teamwork. Excellent written and verbal communication skills along with outstanding organizational skills including attention to detail and accuracy are necessary.
The ability to communicate and operate effectively with all employee levels, ranging from lab associates to senior executives is required.
Provide Quality assistance and oversight during manufacturing of in-process intermediates and drug substance, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.
Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data.
Contributes to driving innovation through continuous improvement of quality processes as well as supporting manufacturing continuous improvement initiatives.
May provide guidance to less experienced staff.
Supports the Quality review and closure of manufacturing investigations.
Other duties as assigned.
This position is a Night Shift (3rd Shift) position that requires working hours of 5:00 pm to 5:00 am EST.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.
Ensure resources are available to provide artwork for new product launches, revisions, submissions, and line extensions. Align artwork deliverables with operation and strategic objectives. Balance revision artwork demands with new product requirements to mitigate any supply interruptions due to artwork and documentation.
Effectively manages artwork availability for new product submissions and launches. Ensures artwork is available to support implementation and aligns with requirements for market availability. Aligns artwork availability with operational and strategic objectives.
Under the general guidance of the Associate Director of Artwork and Documentation, the incumbent is accountable for the effective management of GPT resources responsible for the creation of production quality artwork for printed packaging materials. Demonstrates leadership skills by driving continuous improvement in the artwork process. Encourages/supports individual development and engagement.
· BA or BS degree; and/or equivalent experience desire
Experience / Knowledge Desired:
· 5-10 years project management experience
· 7+ years pharmaceutical experience, Regulatory labeling experience desired
· Ability to work with a range of technically and culturally diverse people to attain desired results
· Ability to effectively communicate to a diverse audience at multiple levels
· Ability to effectively lead cross-functional project teams and drive team performance
• Uses medical knowledge and presentation skills to influence customers to make commitments and take actions that increase BMS products awareness. Effectively communicates marketing messages to targeted customers with the established frequency and implements promotional strategies for Company products.
• Possesses a winning attitude and consistently commits to a standard of excellence and the achievement of superior results, regardless of the task demands.
• Transmits idea and attitudes clearly and effectively in one-on-one discussions and informal presentations. This includes listening, questioning and engaging in open candid dialogue.
• Exhibits excellence in identifying, meeting and exceeding customer expectations by understanding the business environment and partnering with customers to make mutually beneficial decisions.
• Develops productive rapport with customers and Company personnel to optimize the business opportunities
• Assimilates, learns and acts upon new information in a manner that generates business growth for the promoted products in virology & immunology area.
• Evaluates and analyzes available information to consistently make the most appropriate decisions for the Company.
• Supports others to achieve shared objectives and appropriately prioritizes individual goals to achieve team success.
• Adapts and changes style and approach to situations as differing circumstances arise.
• Conducts all planning based on a consistent system for profiling and targeting customers based on prescription potential.
• Makes a positive impression on the customer and commands respect as a businessperson.
• Maintains current knowledge of Company products in the virology & immunology area. Applies in depth knowledge of disease states during the promotional process.
• Focuses on the end results of promotional process, demonstrating personal accountability and commitment to achieve the objective of business.
• Delivers targeted number of customer calls per day per product and specialty on the goal defined by Marketing strategy and Promotion Force Effectiveness.
• Demonstrates understanding of the specifics of working in alliance with other companies and comply with the rigors of such co-promotional activities, without disclosing Company internal information.
• Previous strong experience as a Medical Representative or experience in customer service provision (meeting customer needs/ identifying and addressing customers concerns) – at least 1,5 year
• Influence or ability to persuade customer, to make commitment and take actions
• Winning attitude: believe that oneself can consistently commit to a standard of excellence and achieve superior results, including self-motivation
• Demonstrated success working in a team environment
• Demonstrated ability to work under pressure
• Appreciation of the complexities of interacting with and influencing customers
• Working knowledge of related diseases
• Knowledge of the business drivers within the pharmaceutical industry
• Demonstrates knowledge of the Company brand portfolio and our competitors
• Understanding of the local pharmaceutical market, healthcare environment, customers and competition