Bristol-Myers Squibb 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.

Join us and make a 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.

PURPOSE AND SCOPE OF POSITION:

The Specialist is responsible for quality and disposition activities in accordance with Celgene policies, standards, procedures and Global cGMP.  Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, and performing document issuance for manufacturing.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.   Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Is recognized Subject Matter Expert within the group.
• Provides guidance to other employees in interpretation of complex data.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

DUTIES AND RESPONSIBILITIES

• Review and approval of executed batch records.
• Issue production batch records and product labels to Operations.
• Responsible for disposition of incoming production materials.
• Responsible for release activities for site manufactured drug product.
• Provide oversight of QA shop floor program.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

EDUCATION AND EXPERIENCE (As Applicable)

Relevant college degree preferred, minimum of five years of experience in the pharmaceutical or related industry.

WORKING CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and

used. Work is generally performed seated, but may require standing and walking for up to 10% of

the time. Lighting and temperature are adequate and there are no abnormal conditions caused by

noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

​PURPOSE AND SCOPE OF POSITION:

The Specialist is responsible for quality and disposition activities in accordance with Celgene policies, standards, procedures and Global cGMP.  Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, and performing document issuance for manufacturing.

REQUIRED COMPETENCIES:  Knowledge, Skills

, and Abilities

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.   Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills

DUTIES AND RESPONSIBILITIES

• Responsible for disposition of incoming production materials.
• Responsible for release activities for site manufactured drug product.
• Review and approval of executed batch records.
• Issue production batch records and product labels to Operations.
• Must have ability to author and critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to effectively multi-task.

EDUCATION AND EXPERIENCE (As Applicable)

B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable.

WORKING CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and

used. Work is generally performed seated, but may require standing and walking for up to 10% of

the time. Lighting and temperature are adequate and there are no abnormal conditions caused by

noise, dust, etc.

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Als Study Start-up Specialist (m/w) in der Start-up Unit sind Sie für den Start-up klinischer Studien in Deutschland, Österreich und der Schweiz, unter Einhaltung aller geltender Richtlinien, Vorschriften und Gesetze (ICH-GCP, Arbeitsanweisungen, lokalen Richtlinien etc) verantwortlich. Außerdem führen Sie länderspezifische Machbarkeitsanalysen durch. Dabei evaluieren Sie die medizinische Landschaft in Zusammenarbeit mit weiteren internen Abteilungen und sind in engem Kontakt mit potentiellen Prüfzentren. Die Auswahl geeigneter Prüfzentren, gehört ebenso zu Ihren Aufgaben wie der zeit- und GCP-gerechte Studienstart . Von Ihrem Büro in Wien aus stehen Sie in engem Kontakt mit nationalen sowie internationalen Projektleitern, Ethikkommissionen, Studienmonitoren und Prüfzentren, für deren Training Sie in Teilen verantwortlich sind

Qualifikationen

Sie haben ein naturwissenschaftliches Studium und bringen Erfahrung im Studienmanagement klinischer Studien mit. Ethikeinreichungen und Behördenmeldungen gehören zu Ihrem Tagesgeschäft. Idealerweise haben Sie auch schon Studien im Bereich Onkologie betreut. Sie arbeiten gerne am PC, besonders mit Studienmanagement- und Datenbanksystemen (z.B. Oracle Clinical) und selbstverständlich mit MS-Office. Ihre sehr guten Englischkenntnisse erleichtern Ihnen die internationalen Herausforderungen. Als kommunikative Persönlichkeit treten Sie überzeugend auf und sind kooperativ, teamfähig und zuverlässig in Ihrer Arbeitsweise. Sie besitzen die Fähigkeit wissenschaftliche Sachverhalte klar zu präsentieren und bringen die Bereitschaft zu Dienstreisen mit

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Job Description

The successful candidate will join the Mechanisms of Cancer Resistance Thematic Research Center at Bristol-Myers Squibb in Cambridge, MA and aide in the discovery and advancement of novel therapeutics for the treatment of cancer leveraging both cancer intrinsic and immune intrinsic biology.

The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance drug discovery programs from target identification/validation, to IND enabling activities and ultimately to Proof of Concept in patients.  The candidate will lead a group of scientists responsible for developing and executing in vivo strategies using a wide range of animal models including syngeneic, GEMM, CDX, and PDX tumor models.   The candidate will also have the opportunity to lead multi-disciplinary drug discovery teams and will be expected to work seamlessly with colleagues across BMS Thematic Research Centers and collaborators in medicinal chemistry, MAP/DMPK, preclinical safety, translational research, and early clinical development.

Job Qualifications and Requirements

• PhD with at least 8 years of relevant industry experience and demonstrated expertise in cancer biology, oncogenic signaling pathways, or immuno-oncology is required.
• Demonstrated expertise developing focused in vivo strategies and utilizing PK/PD/efficacy data to drive small molecule lead optimization & characterization as well as translational strategies to enable early clinical development.
• The candidate is expected to have excellent leadership and mentorship skills, including experience leading a high functioning team of research scientists and demonstrated ability to supervise, mentor and develop junior PhDs and associates.
• Experience leading multi-disciplinary drug discovery teams is desired.
• Excellent interpersonal and communication skills with the ability to interact effectively with internal and external colleagues is required. 
• Demonstrated expertise in in vitro/ex vivo assays including qPCR, MSD/ELISA and flow cytometry is needed.
• Competitive candidates are expected to have a strong track record of independent and innovative research as evidenced by publications in top tier peer-reviewed journals.

Job Responsibilities

• Working closely with project teams and key stakeholders, lead the development of in vivo strategies from target concept to Proof of Concept in patients, including target validation, lead optimization & characterization, and development of translational strategies.
• Work closely with colleagues in Translational Research and Early Clinical Development to establish biomarker strategies and play a leadership role in developing preclinical data sets to inform patient stratification and rational combination strategies for novel therapeutics.
• Develop novel animal models that more closely mimic human cancer to enable the discovery of novel biology and answer mechanistic questions, discover and validate therapeutic targets, and screen/profile drug candidates. 
• Serve as oncology biology and drug discovery expert on external collaborations and alliances.
• Provide mentorship to junior PhD scientists and associates in the team.
• Work as a member of a diverse and motivated team of researchers from across Discovery Oncology and key internal and external collaborators. 

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Provide Quality assistance and oversight during start up of clinical manufacturing facility and manufacturing of clinical/commercial drug substance. Performs review and approval of records for the manufacture of in-process materials, drug substance and other GMP processes as required. Assists in the identification, generation and review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Responsibilities:

1. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate as well as site procedures, regulations, and other industry guidelines.

2. Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.

3. Performs walkthroughs of the manufacturing facility and applicable support areas documenting observations and points of concern.

4. Supports return to service walkthroughs and other walkthroughs per procedures as needed.

5. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing and support area related SOPs.  

6. Monitors and trends batch record error and right-first-time batch record review cycle times.

7. Supports disposition and provides Quality Assurance management with quality indicator data. Supports the Quality review and closure of low risk investigations.

8. Participates in the creation of a team based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.  

9. Demonstrates appropriate examples of compliance behaviors and attitudes. Supports on the floor activities in collaboration with Manufacturing and additional support groups as needed.

10. Other duties as assigned.

Education/Experience/Skills:

- 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 quality, validation or manufacturing operations.

- Knowledge of biotech bulk manufacturing, disposable technologies and analytical testing is highly desirable.

- Knowledge of US and EU cGMP regulations and guidance for clinical and commercial phase products is preferred.

- Knowledge of electronic and paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

PURPOSE AND SCOPE OF POSITION:
 The Manager, Global GMP Training and Documentation role supports the training needs of GMP Departments.
 This position is responsible for the development of site and global curriculum, technical training
programs, and Global Quality Systems training programs and implementations.
 This Manager consults with management in the development of training programs and
curriculum.
 The Manager designs and facilitates technical training using a variety of modalities

Basic Qualifications:

Bachelors Degree preferred OR an equivalent combination of education and experience.

8+yrs of GMP, Quality experience.

5+ yrs of GMP Training experience
Knowledge, Skills, and Abilities
 Must have expert GMP, Quality, and in-depth risk management knowledge.
 Must be able to effectively prepare communications with interpretation of data analysis and
potential problems to management and the group with clarity and a high level of accuracy.
 Must provide guidance to other employees in the interpretation of technical issues across a
majority of the job function and manage development of technical initiatives and activities by
interdisciplinary teams. Must develop employees and coach them to bridge knowledge gap.
 Most have strong authorship and be able to critically review reports while effectively inputting
and expressing Quality risk management principles.
 Must be action-oriented and customer-focused and skilled in decision-making, building
relationships, problem solving, conflict management, planning and organizing, resource
allocation, coaching others, and analytical thinking. Must possess an independent mindset and
tenacity.
 Demonstrates expertise in managing the Learning Management System and is a global leader
for technical troubleshooting and support.
DUTIES AND RESPONSIBILITIES
 Responsible for the development, creation, delivery and facilitation of Technical Training
programs.
 Consults with department management to develop department training programs and
curriculum .

 Administers the local GMP Training program, and works closely with the Associate Specialist,
Global Quality Systems to facilitate the interaction of Document Management with the Learning
Management System and approve documents and process training requests.
 Supports Global Quality Operations Systems training programs and implementations.
 Participates in the Quality System implementation process for upgrades and new systems.
 Works with Department Managers on an on-going basis to prioritize training needs and to verify
the effectiveness of cGMP training.
 Demonstrates expertise in all Global Quality Operations Systems, including but not limited to
Change Control, Deviations/CAPA, Product Quality Complaints and Document Management.
 Demonstrates proficiency in training content creation, and interviews key stakeholders to
develop specific training content to meet business needs.
 Develops, facilitates and conducts Annual GMP and Qualified Trainer training.
 Works independently with minimal supervision.
 Forward thinking, seeking opportunities to positively impact the organization.
 Performs other duties as assigned.

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.

Bristol-Myers Squibb 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.

Join us and make a 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 Worldwide Market Access Strategic Director Oncology will be responsible for the Market Access Strategy for one or more of BMS’s portfolio assets or combination of assets in the oncology space. He or she will provide input to the Development and Commercial Strategy organization on the Market Access Strategy.

The MASD Oncology will collaborate directly with several WW Market Access Strategic Leads overarching their IO franchise, and will bring some flexibility in the WW Market Access organization according to the evolving BMS I-O pipeline.

The Worldwide Market Access Strategic Director Oncology will be responsible for the Market Access Strategy for one or more of BMS’s portfolio assets or combination of assets in the oncology space. He or she will provide input to the Development and Commercial Strategy organization on the Market Access Strategy.

The position is cross-functional in nature and is part of a highly matrixed organization. The MASD Oncology will partner with the cross-functional VAP team (HEOR and Pricing Lead) as well as with the extended team (commercial, medical, regulatory, clinical, business Insights & analytics, and policy WW leads) as well as the relevant individual market stakeholders across the world to optimally position BMS products for success in an increasingly challenging and evolving WW access landscape.

The MASD Oncology will have relationships and interactions with stakeholders in field based functional market roles, up to senior worldwide management. A motivated, inclusive, and decisive disposition is essential for success.

Develop in collaboration with HEOR and Pricing an integrated WW Market Access strategy for BMS' in-line and pipeline Oncology Medicines/assets by tumor/indication (e.g. OPDIVO®, YERVOY®, & Pipeline Assets (e.g. IDO, LAG3, & GITR).

Collaborate with R&D and the Development Team to ensure Market Access perspective incorporated into development plans and to optimize our Registrational Trial designs (eg. DEX process, EAR checklist, etc.). Ensure these study designs are timely supported by full evidence generation plans in order to meet payer needs and requirement.

Work with Commercial, Medical, Business Insights and Analytics teams and local markets to monitor external environment and synthesize input to inform Market Access strategy throughout the drug’s life cycle (from GT5 to commercialization)

Ensure that the Market Access Strategy' is supported by strong Payer Value Propositions articulating bold and differentiated messages on clinical, humanistic and economic benefits, and that those propositions are supported by strong bodies of evidence coming from both interventional, non-interventional, and real-world data in time for the first worldwide price negotiation at launch of the Brand or new Indication.

Collaborate with the WW pricing strategy lead to adapt the Worldwide Pricing strategy for assigned BMS' Oncology assets maximizing both speed of access and long-term franchise value -based on Market Access strategy that considers commercial objectives and the market environment we anticipated at launch of the asset/combination of assets.

Collaborate with WW Value & Segmentation Marketing and WW “in region” Market Access to drive the operational execution of the WW Market Access strategy: training of Key markets and early launch markets through VAP meeting & Local IO summit, support for the execution of the Value Pack (incl. Value Story and Core Value Dossier)

Ensure that all recommended Market Access activities comply with regulatory agencies, public policies/guidelines, and with corporate policies and procedures.

Effectively navigate matrix in order to develop and maintain positive relationships with other functional areas and Market Access colleagues in order to drive alignment, consistency where appropriate, best practice sharing, and flawless implementation of all Market Access activities.

Requirements:

Strong understanding of the current and emerging global Market Access environment in Oncology Medicines. 

Demonstrated ability to formulate future Market Access strategy scenarios and lead cross-functional teams, without formal authority, to act on these scenarios.

In depth Market Access experience from one or more countries required.

Proven ability to translate scientific/clinical value into economic value

Minimum of 5-6 years’ experience with a strong track record in Market Access, Pricing or HEOR in a Global/WW or large local markets

Demonstrated ability to change payer perception of a market and in particular to establish unmet needs and drive value perception.

Knowledge of the Product Development and Commercialization Process.

Launch/ commercialization experience desired.

Demonstration of all BMS Behaviors, including Accountability, Innovation, Passion & Speed.

Demonstrated ability of adaptation, flexibility, change, being fast-learner and interacting with multiple environments

Undergraduate degree required, MBA and/or post graduate degree required.

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.

Bristol-Myers Squibb 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.

Join us and make a 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 Bristol-Myers Squibb Biologics Campus in Dublin 15 is a Multi-Product Cell Culture Biologics Manufacturing facility, which is a part of the Global Product Development and Supply (GPS) network. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio and is set to play a central role in BMS’ global manufacturing network. The Global Biologics Laboratory is also located on the Cruiserath campus. This laboratory is responsible for the release testing of Biologics Drug product for the BMS network.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work for 2017, 2018 and 2019.  

BMS Cruiserath Biologics is seeking to recruit a permanent QC Microbiology Analyst. Reporting to the QC Microbiology Supervisor, the QC Microbiology Analyst will be responsible for supporting site activities related to Environmental and Utility Monitoring, IPC and DS, and performing testing of samples and laboratory duties in accordance with cGMP regulations

Key Duties and Responsibilities:

• Performing Environmental Monitoring in Classified Areas (including lot related monitoring), Utility Sampling (Including WFI, Clean Steam and Compressed Gas), associated testing of samples and completion in a timely and accurate manner of laboratory documentation as directed by the Microbiology Supervisor.
• Carry out In-Process and DS release testing of lot related samples
• Compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation, including SOPs, as required.
• Provide support to other departments to ensure qualification and production schedules are adhered to.
• Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures.
• Assisting with Laboratory investigations.
• To ensure a high standard of housekeeping and safety is maintained in the laboratory.
• Performing any other activities as indicated by the Microbiology Supervisor

Qualifications, Knowledge and Skills Required:

• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
• 1+ years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.

Note: This candidate will be required to work a 24/7 shift pattern

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level:

Passion: We pursue excellence to help patients prevail.

Innovation: We embrace new ideas.

Accountability: We own our outcomes and the outcomes of others.

Speed: We act with urgency and agility.

Why should you apply

• You will help patients in their fight against serious diseases
• 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, on-site gym and gain-sharing bonus.

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.

Bristol-Myers Squibb 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.

Join us and make a 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 primary focus of the Capital Projects Manager role is to oversee all aspects of the planning, design, and construction of Juno’s physical infrastructure, including offices, research & development laboratories, and GMP manufacturing facilities. The position, reporting to the Associate Director of Facilities and Engineering works collaboratively with cross-functional stakeholders to plan and implement a variety of capital construction projects to support Bristol-Myers Squibb's growth at the Seattle locations. Capital projects can range from small tenant improvements to complex greenfield construction projects; including facility/utility modifications, office expansions, laboratory build-outs, and cleanroom construction for GMP manufacturing.

Primary Responsibilities:

• Serve as primary project manager for capital construction projects to ensure projects are safely and effectively executed to meet and exceed defined timelines and budgets.
• Assemble project stakeholders and form project teams (internal and external) to define project goals and expectations.
• Work collaboratively with colleagues and cross-functional departments, including Facilities/Engineering, IT, Environmental Health & Safety, Quality, Manufacturing, and R&D to integrate design standards and department user requirements.
• Select and manage design and construction teams including architectural and engineering firms, general contractors, sub-contractors, general service providers, and equipment vendors.
• Manage construction activities, including coordination of field activities, adherence to EH&S programs, management of contracts, procurement of services and equipment, obtainment of applicable permits, compliance with property CC&R’s, and review and oversight of change controls, RFI’s, project drawings, specifications, and submittals.
• Manage close-out and turnover process from construction through start-up, commissioning, and validation, ensuring projects exceed corporate objectives and end-user expectations.
• Own accountability for project performance to meet financial, schedule, quality, and safety objectives.
• Develop and drive end-to-end project schedules, from project inception through completion.
• Develop and maintain comprehensive core project management and governance tools, including schedules, budgets, cash flow models, financial forecasting, risk mitigation plans, safety programs, quality plans, commissioning plans, and contract management
• Coordinate with applicable landlords and property management teams to ensure projects are executed in accordance with lease obligations.
• Provide effective and routine communications and presentations to stakeholders and senior management regarding project progress, status of KPI’s, and project metrics

Qualifications and Requirements:

Education:

• Bachelor’s degree from an accredited four-year college or university in Architecture, Engineering, Construction Management or a field related to the position’s responsibilities.

Experience Required Qualifications:

• 10+ years of professional experience working in senior positions related to design and construction management
• Thorough knowledge of facilities planning, design, and construction, with an advanced understanding of ISO and EU cleanroom standards and BSL-2/BSL-2+ laboratory environments.
• Extensive knowledge of procurement, contracting, and permitting procedures, including industry-related laws, regulations, standards, and best practices.
• Demonstrated management skills and technical abilities to establish and report metrics for project performance goals that measure effective contributions to department goals and objectives.
• Financial management experience creating and overseeing complex budgets.
• A proactive approach to problem solving and the ability to effectively manage/oversee multiple projects simultaneously
• Possession of exceptional interpersonal and communication skills, with the ability to engage stakeholders at all levels of an organization, including internal project teams, senior management, and external agencies and organizations.
• The ability to work independently and as part of a team.
• Ability to speak effectively in public.
• Embodiment of the following competencies: collaboration, effective communication organizational skills, customer/client focus, personal effectiveness/credibility, teamwork, professionalism/composure, results driven, diversity and inclusio

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Roles and Responsibilities

• Assumes full P&L responsibility for Asia Cluster; China, Hong Kong, Singapore, Thailand, Korea, Taiwan
• Oversees all functions including regulatory, medical, clinical, marketing, access, sales, finance, HR and IT
• Maps the landscape and adapts the worldwide strategy to maximize all opportunities for growth
• Leads the development and execution of a customer focused strategy that drives innovation and generates superior short-term and long-term performance through effective resource allocation.
• Actively contributes to shaping the environment and building key relationships with regional stakeholders (internal and external)
• Ability to lead team with agility in a fast moving, dynamic business environment while shaping market access strategy
• Seizes opportunities to enhance the organization’s EVP and public image and serve as an executive and external representative of BMS, builds and manages relationships with internal stakeholders in local, regional, and global roles
• Leverages and influences Worldwide commercial and supporting matrix teams to ensure the right level of region support and alignment with company strategy
• Manages integration points and outbound/inbound communications with key stakeholders across all BMS enabling functions/commercial areas to ensure alignment
• Manages government, industry and policy stakeholders to drive market access in the best interest of patients
• Shapes local and regional health policy where appropriate
• Represents BMS at regional industry groups and organizations as appropriate, e.g., government and regulatory officials, health authorities, payers, industry associations, media, key opinion leaders, physicians, patients, and advocates

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.