We are seeking an Operations/Technical Supervisor I to join the Veterinary Sciences team. As such you will experience a culture that believes in making the animal care and use program a model for the industry. We are focused on providing employees with career development and activities across our entire drug development process.  

Bristol-Myers Squibb is the industry leader in immuno-oncology, Cardiovascular and Fibrosis with life-saving medicines and a rich clinical portfolio of diverse modalities including monoclonal antibody, antibody drug conjugate, fusion protein, and combination regimes.  

Position Responsibilities

Manages the daily operations of multiple animal facilities and specialty area(s) including USDA regulated species, infectious disease/BSL2 areas, and support of in-vivo pharmacology/biology study areas.  

Maintains full ownership of assigned area(s) of responsibility as subject matter expert requiring minimal manager oversight. 

Responsible for upholding regulatory and welfare standards as they pertain to laboratory animal care, husbandry, facilities, and the overall animal macro environment. 

Sets standards and provides guidance on daily operations, animal room preparation, environmental parameters, and relevant reports and takes corrective action as necessary. 

Assists in the oversight of daily activities and development of staff and programs. 

Works with PI’s and staff to optimize workflows for in-vivo studies. 

Reviews staff work assignments and ensures quality performance of assigned tasks.   

Leads the reviews and updates VS Standard Operating Procedures (SOPs) according to the assigned review schedule. 

Manages and develops assigned staff consistent with Company strategy and to achieve departmental objectives. 

Leads supervisory team in developing cross functional capabilities and building team effectiveness.  

Recommends, develops, and delivers training programs for VS employees and research staff on proper techniques required for compliance with research protocols.  

Meets regularly with research staff to assess their research animal needs and appropriately plan for efficient program support. 

Oversees the maintenance, use, disposition, and inventory of equipment for animal care or laboratory activities 

Leverages basic knowledge and understanding of clinical observation and treatment methods to enhance animal care program and health and wellbeing of animals 

Partners with staff to craft development plans in relation to company strategy to achieve departmental objectives.  

Recommends, develops, and delivers training programs to create growth opportunities for VS and research staff  

Supervises the maintenance, use, disposition, and inventory of equipment for animal care or laboratory activities. 

Provides assistance with major project/program activities in the department which may involve multi-site interactions. 

Competencies – Knowledge, Skills, Abilities

The individual is required to have knowledge of experimental methodology, facility operations, and knowledge of regulations and guidelines that govern animal care and use programs. 

Must have mastery of all VS SOPs and a good understanding of related departmental procedures (EH&S, Facilities, etc.) and proficiency in integrating this knowledge with strategic objectives.  

Must have outstanding team building skills and demonstrated leadership and managerial abilities. 

Must have a solid foundation in the care and maintenance of USDA (Animal Welfare Act) regulated species as well as the regulatory requirements for maintaining those animals.  

Must also have a clear understanding accrediting guidelines (The Guide for the Care and Use of Laboratory Animals) and AAALAC for facility operations. 

Experience – Responsibility and minimum number of years

Must have a history of consistent, sustained, high-level performance typically attained with 7-10 years relevant experience in a laboratory animal facility. 

Must have knowledge of the site processes and key contacts such as Medical, HR, investigators, EHS and Facilities required to coordinate project-related activities. 

Must have an excellent understanding of research animal facility operation, to include animal welfare practices, husbandry procedures, animal health and veterinary care, enrichment program, and applicable regulations/accreditations (USDA, AAALAC, OLAW, and site/departmental SOPs). 

Qualifications

Bachelor of Science (BS) in life sciences or an Associates with at least five year of supervisory experience. 

Individual must have AALAS certification at the Laboratory Animal Technologist (LATG) level.  

AALAS Certification at the Certified Manager of Animal Resources (CMAR) is preferred. 

 Masters of Science (MS) in Molecular Biology or Laboratory Animal Science and/or a Masters of Business Administration (MBA) is preferred. 

Key Responsibilities and Major Duties

• Partners to proactively monitor data quality within a core application that interacts with multiple applications to support staffing for clinical drug development programs. Examples of systems include Eclipse, Planisware, Beeline, eReq, SAP, OrgPlus, ECLIPSE, ePlan. (25%)
• Conducts root cause analysis, triages findings, applies judgement around potential solutions (25%)
• Resolves data quality issues and communicates remediation plan to stakeholders (25%)
• Ensures compliance with policies, procedures, and data definitions (10%)
• Uses data quality reports and tools to identify issues and monitor quality (15%)

The data being managed by this role is used for strategic and tactical decision-making -- driving insights across R&D, including headcount management, resource planning & forecasting. 

Requirements

• Bachelors Degree or 4 years equivalent experience required in a scientific or professional field.

• Preferred fields of study are Management Information Systems, Business/Data Analytics, Data Science.
• 3+ years of related experience
• Experience in pharmaceutical industry is preferred
• Experience working with HRIS systems like Workday, Beeline or familiarity with handling employee data highly preferred
• Business intelligence and analytics skills
• Demonstrated keen sense of detail and accuracy
• Analytically minded, with strong critical thinking skills
• Experience in maintaining and improving data quality, identifying data gaps and root causes, and ensuring compliance with policies, procedures and data definitions
• Proven customer service and follow-up skills
• Ability to communicate and document findings in a logical and understandable manner

Description

This role will have accountability as the WW Medical Specialist for Immuno-Oncology (I-O)/Flex, supporting the listed tumor teams and New and Early Assets Teams, reporting to the WW Medical SCCHN/GBM/Breast/Emerging Tumors/New and Early Assets Lead. He/she will participate in the cross functional matrix teams to provide scientific and medical support on behalf of WW Medical as well as development and execution of the WW Medical SCCHN/GBM/Breast/Emerging Tumors/NKTR-214 strategy (communication, publication, and ISR strategy).

Responsibilities include: supporting development of medical strategy; leading symposia, congress, and advisory board meeting planning; providing medical input for development of booths, congress materials, and medical information letters; and supporting the execution of publication strategy (abstracts, manuscripts, and congress presentations).  He/she will partner closely with medical colleagues in the Markets, with Clinical Research, Regulatory, Commercial, Access, Health Outcomes, Publications, and other key functions.

Qualifications

The successful candidate must be highly professional with excellent relationship-building and communication skills, including the ability to articulate both verbally and in writing complex scientific principles. He/she must have experience working in multifunctional project team and managing external agencies. Additionally have the skills to plan and implement medical congresses and advisory boards. Life sciences and/or healthcare professional training with an advanced degree is require (RN, Pharm. D, MPH, PhD, MD). Prior industry experience in Oncology Medical affairs, Clinical Research or related experience is preferred.

This role will have accountability as the WW Medical Specialist for Immuno-Oncology (I-O), supporting the Genitourinary team and flexing across tumors, reporting to the WW Medical GI/GU/Melanoma/Cross Tumor Lead.

Description

This role will have accountability as the WW Medical Specialist for Immuno-Oncology (I-O), supporting the Genitourinary team and flexing across tumors, reporting to the WW Medical GI/GU/Melanoma/Cross Tumor Lead. He/she will participate in the cross- functional matrix teams to provide scientific and medical support on behalf of WW Medical as well as development and execution of the WW Medical GU strategy (communication, publication, and ISR strategy).

Responsibilities include: supporting development of medical strategy; symposia, congress, and advisory board meeting planning; providing medical input for development of booths, congress materials, and medical information letters; and supporting the execution of publication strategy (abstracts, manuscripts, and congress presentations).  He/she will partner closely with medical colleagues in the Markets, with Clinical Research, Regulatory, Commercial, Access, Health Outcomes, Publications, and other key functions.

Qualifications

The successful candidate must be highly professional with excellent relationship-building and communication skills, including the ability to articulate both verbally and in writing complex scientific principles. He/she must have experience working in multifunctional project team and managing external agencies. Additionally have the skills to plan and implement medical congresses and advisory boards. Life sciences and/or healthcare professional training with an advanced degree is require (RN, Pharm. D, MPH, PhD, MD). Prior industry experience in Oncology Medical affairs, Clinical Research or related experience is preferred.

PRINCIPLE OBJECTIVE OF POSITION

The Sr. Scientist/Engineer of External Manufacturing Technology will provide technical support for manufacturing of BMS biologic drug products at Contract Manufacturing Organizations (CMO’s) in the US,  EU, and abroad.  The individual will act as single point of contact for technical matters at the CMO, and may perform Person in Plant duties (PIP) in support of technical transfer and commercial manufacturing activities. 

This position will report into the Associate Director of Biologics Drug Product External Manufacturing located in Cham - Steinhausen, Switzerland. This position will be located in Cham – Steinhausen, Switzerland. 

MAJOR DUTIES AND RESPONSIBILITIES

• Participation in CMO/vendor selection with Procurement, Quality, and other business functions. 
• Technical single point of contact and BMS Site Implementation Lead to contract manufacturing organizations in support of technical transfers. This includes review and approval of site technology documents such as Engineering Studies, characterization Protocols, Validation Protocols, Process Risk assessments, etc.  This likely will include Person in Plant (PIP) support
• Execution of Process Owner Role at contract manufacturing sites.  This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO , identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews and to support generation of Annual Product Quality Review documents for commercial products.
• Leadership or support of critical manufacturing or complaint investigations that involve significant product impact including root cause analysis, CAPA generation, and impact assessment
• Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
• Participation on matrixed Technical Product Teams to drive technical process improvement strategies.  Must generate presentations to support development, approval, and execution of technical plans
• Employment of resources and processes (OPEX etc) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.

This is intended to be a general job description and should not be construed as all inclusive.

KNOWLEDGE / SKILL

Education:

• Strong technical knowledge of sterile manufacturing technology and processing techniques, with a minimum of 8 years of experience as a BS degree, 6 years of experience as a MS degree and 4 years experience as a Ph. D is required.
• A bachelor’s degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Masters or PhD level degree is strongly preferred.

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 these processes. 
• Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
• Demonstrated experience with the execution of Technology Transfer and scale up programs for commercial drug product manufacturing processes.
• 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. 
• Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements. 
• Statistical analysis capability, including use of statistical software platforms (e.g. Minitab, JMP) to determine trends and variability across inter-batch data sets.  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 30-50% travel, mostly to CMO sites.  May require Person in Plant (PIP) temporary assignments, where location at site is up to 75% for a temporary time period
• 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 Procurement, Quality, and CMO 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 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:

• Decide & Act: Define a clear picture of the future and the plan for how to get there; hold people accountable for driving individual and team performance; execute while balancing operational and strategic perspectives; drive decision making to the right level; focus resources on the most important work.
• Connect & Collaborate: Remove silos and communication barriers; energize team to achieve shared goals.
• Innovation & Improve: Act as a catalyst for changes that improve business performance; create an environment in which innovation is encouraged and supported.
• Grow & Engage: Create and execute an actionable plan to grow, develop and engage each employee; communicate and reinforce link between each employee’s work and BMS strategy & mission; support work life considerations; create an inclusive culture that leverages colleagues unique interests and contributions; extend trust and provide autonomy for employees to own their work.

The Protein Interactions Group is seeking a skilled and enthusiastic Senior Research Investigator who will guide biophysical support for oncology programs and who loves hands-on bench work to provide quantitative data that drive decisions in a highly collaborative environment. You will play a critical role in enhancing and developing the capabilities of the Protein Interactions group to select and optimize therapeutic antibodies.

Specific Responsibilities

Drive the development of new biophysical assays and new, better high throughput capabilities for binding kinetics and epitope binning.

Lead junior members of the group

Contribute to discovery team meetings for a variety of oncology projects, determine biophysical project needs, present data and analysis in written and oral form

Collaborate closely with Biology, Antibody Generation, Automation, Scientific Computing and Protein Engineering groups on-site. Collaborate with other biophysical groups across BMS.

Requirements

PhD in Biophysics, Biochemistry or related field with 10+ years of professional experience

Experience in managing discovery teams and track record in drug discovery

Strong biophysical expertise and strong hands-on skills for characterizing protein interactions a must

Hands-on experience with biosensor platforms (Biacore, Octet, etc.) as well as cell binding assays (e.g., flow cytometry) highly desirable

Experience with automation and R scripts desirable

Excellent written and oral communication skills

Excellent time management and organizational skills

Bristol-Myers Squibb è una Global Biopharmaceutical Company la cui mission è scoprire, sviluppare e rendere disponibili farmaci innovativi che aiutino i pazienti a combattere gravi malattie. La pipeline di Bristol-Myers Squibb è riconosciuta come una tra le più produttive del settore, con 14 nuovi farmaci resi disponibili per i pazienti negli ultimi 10 anni e oltre 35 molecole in studio con un investimento in R&S di 4,9 miliardi di dollari nell’ultimo anno.

Nell’ottica del potenziamento della nostra struttura siamo alla ricerca di un/una

MEDICAL SCIENCE MANAGER

che avrà la responsabilità di fornire agli operatori sanitari approfondimenti scientifici relativi ai farmaci BMS nell’area della Cardiologia.

             Responsabilità:

• Comunicare i dati scientifici agli operatori sanitari sia singolarmente che attraverso incontri di gruppo.
• Sviluppare e mantenere contatti con gli esperti scientifici per comprendere meglio le necessità mediche relative a specifiche patologie.
• Contribuire all’attività di divulgazione scientifica identificando e collaborando con i relatori dei convegni organizzati da BMS.
• Contribuire all’identificazione dei centri per la conduzione degli studi clinici sponsorizzati da BMS.
• Comunicare dati di Farmaco-Economia (HEOR) relativi ai farmaci BMS

  Requisiti:

• Laurea Scientifica e preferibilmente pregressa esperienza nel ruolo
• Capacità di pianificazione del lavoro ed autonomia organizzativa
• Elevate capacità di relazione ed esperienza di presentazioni di gruppo
• Conoscenza delle sperimentazioni cliniche in GCP e dell’interpretazione dei dati provenienti da studi clinici
• Adeguate conoscenze informatiche (Office, Outlook, Web, etc.)
• Buona Conoscenza della lingua Inglese
• Gradita esperienza in ruoli di Direzione Medica in altre aziende farmaceutiche
• Domicilio/Residenza: Emilia Romagna

  Contratto: Tempo DETERMINATO

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. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.

Bristol-Myers Squibb External Manufacturing is looking to recruit a permanent QA Senior Specialist, Actives & Intermediates based in Ireland. The role will be responsible for the quality oversight of our contract manufacturers (CMOs), supplying various APIs, chemical intermediates and starting materials to the Global market. The QA Senior Specialist, Actives & Intermediates will report directly to the Quality Operations Manager .

Key responsibilities will include, but not limited to:

• Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO’s
• Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process verification/campaign reports for CMO’s where relevant.
• Ensure qbD principles are implemented for all new products at CMO’s. Review and approval of process risk assessment, process verification reports for CMO’s for intermediates and API. Support pre-approval inspections
• Manage all activities associated with vendor approvals
• Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
• Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
• Manage the quality metrics programs in relation to CMO performance.
• Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
• Prepare, negotiate and approve Quality Agreements  with CMO’s
• Review and approve the Annual Product Reviews submitted by the CMO’s Support the Global BMS external auditing program by participation in audits of Third Parties as requested.
• Mange information/provide information for quality council meeting
• Assess and implement corporate policies and directives
• Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends

​

Qualifications and Experience required:

• Requisite experience required to efficiently support the selection of new contract manufacturing partners and suppliers for APIs.
• In addition the candidate must be competent to work across cultures and geographies in an integrative manner.
• A BSc Chemistry in addition to a minimum of five years of experience in a GMP environment, having spent a minimum of five years in a QA position. 
• Excellent communication skills and relationship building expertise with both suppliers and business partners. 
• Goal-oriented approach to project management coupled with the ability to manage simultaneous projects. 
• Excellent organisational and administration skills are required in addition to strong interpersonal skills.
• Thorough knowledge and understanding of Regulatory requirements and filing processes is required.
• Operational Excellence qualifications are an advantage.
• Confident management of internal and external stakeholder relationships

• 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.

• In the absence of the Associate Director, Quality Operations Global API, the Quality Operations Senior Specialist can act as designee, review and approval of change controls, signatory on  GMP documentation, representation at meeting.

Note: Travel will be required on a routine basis as part of this role (approx. 25%).

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 Senior Scientific Adviser Oncology is responsible to actively engage with Thought Leaders and to serve as the Oncology reference point within their geographic scope. The Sr. SA is responsible to design and deliver the medical plan, provide medical support to internal matrix partners, and support clinical trial activities.

External Environment and Customer Focus :

• Role model in developing and maintaining peer-to-peer relationships and close contacts with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer unsolicited product and HEOR related questions.
• Master proficiency in available scientific resources and presentations. Effectively present information to HCPs, as appropriate, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives.
• Actively profile the medical and competitive landscape to effectively evolve planning at the market level within the medical team and matrix leadership teams, as appropriate.
• Collect, analyze and present meaningful medical insights back to the medical and commercial organizations at brand team meetings to be actioned in support of the strategy development.

  2. Design and Deliver the Medical Plan                     

• Deliver scientifically meaningful medical programs proposals and ensure flawless execution of medical activities to support overarching medical plan execution.
• Discuss and deliver Health Economics and Outcomes Research (HEOR) evidence based information reactively (ie, to government agencies, healthcare organizations, and payers), as appropriate.

  3. Provide Medical Support

• Lead cross functional collaboration within matrix teams to ensure appropriate embedding of the medical perspective and aligned focus in key critical execution to achieve overall medical strategies and objectives.

• Represent medical as a key reference point for internal stakeholders and a regional reference for other SA’s (mentor or coach); demonstrate the ability to train SA’s by supporting with role play simulations and/or co-visits, while acting as a role model.
• Facilitate continuous improvement towards higher quality work and promote innovation within the local team.

Support Clinical Trial Activities :

• Contribute to the “early prioritization” of development programs for the country by collating and integrating data on disease incidence / prevalence, treatment patterns, unmet medical needs and interest from the scientific community, as appropriate; Serve as point of reference for compounds in early development

• Actively track study performance and contribute with insights and solutions

• Ensure that BMS Pharmacovigilance procedural documents are understood and applied by Investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events.

Additional Sr. SA Responsibilities

• Deliver the medical / scientific sections of pricing and reimbursement files

• Act as medical study director / study monitor, if appropriate and in agreement with local medical management
• Identify local needs and provide input into NRDG strategy development
• Provide strategic input into the development of Brand plans and drive the development and execution of the medical plan and related TL interaction plans. May contribute to regional / Worldwide medical plans.
• Actively provide coaching through customer facing field visits for scientific advisor

Responsibilities

As a core member of the IMS Medical team, is responsible for providing input and advice to conduct the review of promotional materials for scientific/medical validity.  For example, determine acceptability of data/references used to support promotional claims and provide expert guidance as well as effective negotiation leading to resolution for approval of pieces

Critically review and recommend changes to promotional materials/activities to ensure balance of the messages, medical accuracy and appropriateness of the content of the materials/activities in accordance with relevant guidance.

Proactively align and build strong relationships with champions and other advisors/stakeholders on issues or concerns to provide medical advice to ensure balance of messages in accordance with relevant guidelines.

Participate in internal and external meetings (training, educational and others, including medical congresses) to remain current on ever changing regulations, relevant new medical/scientific information and commercial strategy

Qualifications

PharmD, MD or PhD preferred with minimum of 2 years’ experience in clinical practice or the pharmaceutical industry.

Demonstrates thorough understanding of medical writing and medical review of promotional materials in the pharmaceutical industry

Demonstrated ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams.

Strong scientific/medical written and verbal communication skills required.

In-depth knowledge of the pharmaceutical industry as well as the external compliance, transparency & conflict-of-interest environments preferred

Experience in delivering a customer-focused service

Business acumen and ability to impact and influence internal stakeholders

Strong leadership and organizational skills with demonstrated success in driving optimal business results in a complex matrix organization required

Prior experience in therapeutic area preferred