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.

Talented Commercial Lawyer

BMS is seeking a talent Commercial & R&D Lawyer ANZ, to provide legal support for BMS affiliates in ANZ. You will effectively support the Australia & NZ business, as well as liaise with legal colleagues supporting global markets across different regions, BMS worldwide functions, the Law department’s transactional practice and the global Compliance and Ethics Organisation. 

BMS is Australia's fastest growing biopharmaceutical company with a rapidly expanding portfolio of innovative therapies and indications. We are committed to improving patient outcomes and the Commercial & R&D Lawyer ANZ performs a crucial role in enabling patients to access vital medications.

Career Development, Rewards, Culture

BMS is focused on developing employees and investing in you. Leaders work with you to define career development goals and facilitate access to new opportunities to broaden your experience, knowledge & skills.

BMS is committed to rewarding workers for great performance, ensuring individuals are compensated fairly for the work they deliver and how it is delivered.

BMS is proud to welcome new employees into a diverse, inclusive and innovative culture. We are diverse in every dimension: from gender to ethnicity, to experiences and skills. We believe inclusivity unlocks the power of diversity, leading to innovation that drives better outcomes for patients.

Responsibilities include:

• Supports ANZ Legal & Compliance team
• Awareness of tone throughout the ANZ markets and ensuring a steadfast commitment to quality, integrity, compliance and uncompromising ethics
• Liaise effectively with worldwide lawyers (including commercial, R&D, patents, copyrights and trademarks, human resources law and litigation) supporting global functions within BMS, including ensuring appropriate support of global or regional projects
• Maintain knowledge of business and markets and legal and industry trends to identify and mitigate potential legal risks
• Representative or coordination of participation on various external legal bodies.
• Support appropriate corporate governance
• Ensures team supports business activities and appropriate decision-making through
• Deliver pro-active, practical, solution-oriented advice that drives informed decision-making in support of commercialization strategy and execution. 
• Substantive areas of focus include the FCPA, local and other anti-bribery laws, local privacy law, advertising and promotion, pricing and reimbursement, contracts, competition law, and compliance and policy issues 
• Proactive identification and mitigation of potential legal risks
• Stakeholder engagement inc. General Manager, Business Unit Directors, Finance, Medical, Regulatory, Market Access, Pricing & Reimbursement, Government Affairs, Clinical Operations, Public Affairs, Digital etc.

Essential Experiences, Skills & Qualifications:

• Education: A law degree from an Australian University.
• Qualification: Admission to practice in a State or Territory of Australia and a valid legal practicing certificate in an Australian State or Territory.
• At least 4 years of commercial/corporate legal experience is required. Experience in the pharmaceutical industry is preferred.
• Knowledge of Australian and NZ pharmaceutical industry practices, applicable industry codes and relevant laws is preferred. 
• Superior personal integrity and ethics, including an exceptional sense of discretion.
• Demonstrated ability to establish and maintain strong relationships across stakeholders/clients/customers.
• Ability to prioritize and manage multiple projects under deadline pressure.  Flexibility to work on a broad range of matters. 
• Ability to communicate complex issues clearly, verbally and in writing.

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.

下記役割を、方針・方法について生産技術課長と事前に相談し、必要に応じて助言を受けながら実施し、結果を生産技術課長に報告す る。

〆   新製品導入プロジェクト： 愛知工場内のプロジェクトチームのプロジェクトチームリーダー或いはメンバーとし以下を実施する。

》 BMSKK  新宿本社の製剤会議やブランドチームにメンバーとして参加する。そして、新製品情報を適切な時期に入手し愛知工場 内のプロジェクトチームへ伝達し、或いは愛知工場の情報を製剤会議やブランドチームへ提供し、愛知工場内のプロジェクトチ ームメンバーをリードして愛知工場の予定・アクションを立案・管理し実施する。

》 BMS 海外部門から新製品情報を適切な時期に入手し愛知工場内のプロジェクトチームへ伝達し、或いは愛知工場の情報を BMS 海外部門へ提供し、愛知工場内のプロジェクトチームメンバーをリードして愛知工場の予定・アクションを立案・管理し実施 する。

》 新製品導入に工程の変更・新規設備導入が必要な場合、CAR 承認関連業務（機器選択・コスト情報入手・申請書作成を担当部 門に依頼〉を実施する。

》   新たなバリデーションが必要な場合、担当部門と協議しながら計画立案し、担当部門の実施を管理しその結果を検証する。

〆   既存製品(あるいは新製品)の圏内外の製薬工場への委託： 生産技術のスタッフとして以下を実施する。

》   委託の要求事項を、BMS 海外部門や BMSKK 新宿本社等から入手する。

》   複数の候補を選定し、必要なら工場訪問しその適格性を判断する情報を得る。その情報を生産技術課長に報告する。

》 秘密保持に関する契約締結後、委託に関する業務（要求事項開示、コスト評価、due diligence、バリデーション確認、GMP 監 査、製造委託に関する契約等〉を実施する。

》 委託先で工程の変更・新規設備導入が必要な場合、必要なバリデーションに関して委託先の計画作成時から BMS の要求事項 を伝えその実施を依頼する。その為コストが発生する場合は、生産技術課長に報告する。そして実施されたバリデーション結果 を検証する。

〆   愛知工場のバリデーション管理： 生産技術のスタッフとして以下を実施する。

》      GMP に関するバリデーション業務（上位 SOP・計画書・報告書・記録書等の作成及び承認、BMS 海外部門や規制当局の要求事項の確認と必要ならその実施〉の実施

》   規制当局の査察及び   GMP     監査では、必要に応じて、バリデーション全般について立会い、必要なら指摘事項に関する改善策 を担当部門と立案し、その結果を検証する。

》   医薬品物流の技術に関する業務（輸送試験・落下試験、保冷庫・空調倉庫・輸送車両等の温度マッピング検証、断熱容器の開 発・能力検証、cold chain の検証等〉の実施

〆   その他のプロジェクトや業務： 生産技術のスタッフとして以下を実施する。

》   改善プロジェクト（品質改善・CI・Operational   Excellence   等〉で、チームメンバーとして具体的に必要な改善を立案・実施

》   愛知工場にとって GMP・GDP  や生産機器・施設に関する新情報の入手や、新規技術の検討とその導入実施

〆    担当業務及びプロジェクトの予算管理： 生産技術のスタッフとして以下を実施する。

》   新製品導入等担当プロジェクトのスタートアップコスト情報を生産技術課長に報告する。

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.

We are seeking talented hematology sales professionals with a proven track record and the drive and initiative to sell in markets that revolve around complex science.  BMS has been consistently ranked as one of top sales forces in the industry, because of the knowledge and support the sales team demonstrate to improving the lives of the patients we serve. BMS is an organization that not only recognizes performance, but also the manner in which performance is achieved.

Hematology Consultants are responsible for achieving all territory sales goals through the promotion, sale and support of company products or services in his/her geographic territory. This territory encompasses….

Responsibilities include:

• Communicating with physicians and health care professionals in support of approved product indications.
• Providing customers with assistance in the best application of products: answers all questions concerning products, with appropriate referrals where required.
• Preparing and implementing a comprehensive business plan for territory.
• Contacting prospects and explaining features and benefits of products offered, utilizing persuasive sales techniques all within the boundaries of the BMS Promotional Policy.
• Collaborating with a variety of internal cross functional partners to include clinical nurse consultants, patient support specialists, marketers, account managers, advocate development managers, professional alliance managers and clinical liaisons.
• Planning and organizing promotional speakers programs in territory in partnership with Speakers Bureau vendor and advocate development managers.
• Communicating competitive market intelligence to brand teams and management. 

Required Skills/Knowledge:

• BS in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry with at least two years of related hematology/oncology sales strongly preferred (or proven success in medical field).
• Proven track record that demonstrates top sales accomplishments.
• Demonstrated ability to understand and communicate technical clinical material clearly and effectively.
• Ability to develop critical relationships with physicians, nurses and ancillary staff within academic hospitals, clinics, and private practice facilities.
• Demonstrated understanding of oncology therapeutic area, products and marketplace.
• Demonstrated knowledge of healthcare system processes including reimbursement.
• Strong work ethic and ability to develop priorities and manage time appropriately.
• Ability to work successfully within a team environment.
• Ability to integrate innovative ideas to accomplish corporate and individual objectives.
• Prefer individuals with the desire/ability to relocate for roles of different scope or responsibility.

• Occasional overnight travel is 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.

KEY ACCOUNTABILITIES/ OUTCOMES:

• This position has the primary responsibility to contribute to the Global Medical Affairs strategy and tactics in the assigned indications/assets within the Myeloid disease area (i.e. Myeloid Leukemias). Represent Global Medical Affairs in cross functional interactions with other Global functions, providing supporting to countries within the assigned scope.

• This position may lead to substantial travel time including Medical Affairs strategy meetings, educational meetings, advisor boards, individual KOL meetings, EU and US congresses, among others.

Medical Affairs duties include:

• Co-lead medical strategy, defining Global Medical launch plan & Budget
• Represent Global Medical Affairs in cross functional meetings (Business review, Global Marketing Medical Affairs and Market Access meetings, country visits)
• Assess IIT proposals and inform the integrated evidence plan and open research questions
• Lead scientific communication with the leukemia international community (e.g. OL engagement plan)
• Plan and lead execution of Scientific Communication Activities (e.g. scientific symposia)
• Support relevant independent Medical Education initiatives as per medical plan (grants & sponsorships)
• Provide Medical insight into publication strategy and review of individual manuscripts/abstracts
• Provide Medical insight into Markets Access projects (Chart review, ITC) and other documents as requested (e.g. Global Value Dossier)
• Update and support the BMS countries in the preparation of launch plans
• Plan and develop training activities (F2F, webex, on demand, etc.)

COMPETENCIES AND BEHAVIORS

1) Teamwork is the ability to work cooperatively with others, to be part of the team, to work together, as opposed to working separately or competitively. Teamwork may be considered whenever the subject is a member of a group of people functioning as a team.

Behavioral Evidence Level

• Works closely with internal and external partners to continually assess relevance of ongoing projects
• Provides consulting expertise (e.g., publications, slides, printed materials, training, etc.) to internal partners when requested.
• Participates in team meetings as appropriate to understand operational, strategic, research and other adhoc issues being conducted and maintain current interests and involvement.

2) Problem Solving & Decision Making is the ability to make quality & timely business decisions based on data and facts. It involves taking responsibility for identifying and solving problems and managing risks.

Behavioural Evidence Level

• Creates new models or concepts not obvious to others to explain situations, clarify an opportunity and resolve problems.
• Makes timely recommendations and/or decisions that balance multiple factors (e.g., business needs, scientific data, ethical implications, etc.)
   

3) Influence & Persuasion involves influencing others to a desired outcome through building persuasive scientific arguments based on logic and fact, coupled with the ability to anticipate and respond to the needs and concerns of others.

Behavioural Evidence Level

• Delivers presentations to target audiences that clearly communicate research benefits or the value of completed research, in line with each audience’s unique concerns or interests.
• Is able to identify and balance the needs of multiple stakeholders. Can demonstrate ways to meet the diverse needs of different interest groups and negotiate mutually beneficial outcomes.
• Uses knowledge of step-by-step influencing approach study approval (e.g., assist with building study concept, position with internal partners, develop full protocol, engage supervisors appropriately)

4) Planning, Organizing & Coordinating Work Efforts involves efficiently completing work activities and requirements through effective planning, organization, resource utilization, and time management.

Behavioural Evidence Level

• Develops and implements efficient functional work plans, which may involve several groups. 

• Monitors plans and related progress within all studies and develops contingency plans as necessary. Maintains timely communication with key stakeholders as appropriate.
• Organize time-share spent in the European territories in relation with appropriate workload as defined concomitantly with the supervisor.

5) Sound Technical and Scientific Knowledge means being at all times informed about trends, current opinions and standards of care in the treatment of different tumor types as well as all issues pertaining to protocol development, appraisal and monitoring, and scientific data reporting

Behavioural Evidence Level

• Effectively discusses clinical protocol rationale, design and issues based on current knowledge in the field
• Is able to articulate, illustrate and defend a scientific/ medical issue in the setting of a group discussion
• Makes effective use of scientific and medical literature to support studies, analyze and review study proposals
• Delivers presentations with depth of content, clear delivery of ideas and messages and is able to satisfactorily field questions using her knowledge

Skills/Knowledge Required:

MINIMUM QUALIFICATIONS:

• MD or Biomedical Science advanced degree
• 8+ years of experience in pharmaceutical industry Medical Affairs
• Preferably 5+ years of medical and/or research experience, preferable with focus on oncology or hematology
• Good understanding of industry environment
• Solid organization and project management experience
• Good presentation skills
• User of Office tools (Word, Excel, PowerPoint, etc)

Preferred Requirements:

• Experience working in Myeloid malignancies
• Superior interpersonal skills
• Proven ability to multitask and prioritize critical company issues within the drug development lifecycle

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.

Profile Description:

The AD, Clinical Innovation Lead is an essential role in the evolution of Global Development Operations within the Clinical Trial Business Capabilities group. This is a strategic role reporting to the Director of Clinical Trial Business Capabilities and is accountable for exploring and implementing new clinical innovation and digital opportunities to improve GDO productivity and effectiveness, site & patient experience and engagement in BMS clinical studies and enable BMS to become an industry leader in light of Clinical Innovation. The role will be accountable for executing a strategy, roadmap and governance for investments within Clinical Innovation at BMS GDO.

Working closely with different stakeholders within Global Development Operations, the AD, Clinical Innovation Lead will drive the implementation of a strategy that supports the delivery of innovative clinical development and clinical operations opportunities. The incumbent will design and align agile and creative opportunities in areas such as clinical trial awareness, recruitment and retention, digital and remote clinical trials, patient & site engagement, patient & site experience, electronic data capture, monitoring, compliance, automation and others.

The AD, Clinical Innovation will be responsible for driving a comprehensive approach to implementation of innovative clinical technologies across Global Clinical Operations ensuring alignment and synergy across different functional groups. The role is also accountable for the continuous assessment of the competitor and external partner landscape to identify new opportunities/industry trends for innovative approaches, for exploration at BMS GDO.

The role will also develop and/or support key relationships and collaborations with external partners/academic institutions when appropriate to co-develop and drive innovative clinical development and clinical operations solutions. The role is also accountable for ensuring proper change management, governance and continuous improvement activities are led in a cost effective, compliant manner related to Clinical Innovation.

Key Responsibilities and Major Duties

Develop strategy, business cases, proofs of concepts and pilot proposals and implementation plans to enhance clinical operations and clinical development processes

Engage with key stakeholders across GCO to identify opportunities of unmet need across clinical strategy and operations, clinical development, and develop innovative clinical trial approaches to optimize business areas.

Influencing and driving members of key enabling functions including Information Technology to ensure the implementation, management, and support of clinical innovation and digital capabilities.

Develop strategic profile and existing landscape of vendors, partners and startups to map innovative capabilities to business needs

Ensuring clear and effective business ownership, governance, and support of clinical innovation.

Lead evaluation, prioritization and planning for future innovation opportunities to be used in clinical operations and clinical development

Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of clinical innovation opportunities.

Collaborate with clinical study teams or development teams to prepare business cases, and support protocol generation, due diligence activities, process development, risk mitigation, implementation and quality & change management.

Collaborate with patient groups and sites to understand patient and site needs, and perspectives regarding real world application to drive continuous improvement, education and learning

Coordinate with stakeholders across the enterprise to ensure strategy and planning for clinical innovation is aligned, synergistic and where required, scalable

Conduct ideation and innovation sessions to enable the formation of new ideas using known methodologies (i.e. Design Thinking)

Communicate and infuse lessons learned across the organization to promote a culture of continuous improvement

Requirements

Bachelor’s degree required with an advanced (Masters) degree preferred.  Minimum of 5 years of direct experience in innovation or clinical trial technologies. Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills.

Experience in clinical trial, data, or technology management

Experience in setting strategy, planning, implementation

Robust understanding of biopharmaceutical industry, clinical trial conduct, regulatory and safety processes, and the external and internal Business Environment

Knowledge of GCP/ICH guidelines, regulations

Proven ability in managing day-to-day Planning and Operational activities and ability to lead people and teams towards a shared vision to drive innovation

Proven ability to build strong relationships with external companies and partners

Experienced in communicating and interacting with Senior Executive stakeholders

Customer focus - dedicated to meeting the expectations and requirements of internal and external customers and consumers

Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts

Ability to analyze and interpret complex issues and propose innovative solutions

Experience with leading teams and driving innovation

Experience in managing vendor relationship and stakeholder management

Ability to analyze and interpret complex issues and propose innovative solutions

Strong project management and planning skills

Effective oral and written communication skills to influence, inform, or guide

Experience working in a matrix environment.

Commitment to leadership, diversity and talent development

Ability to travel as 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.

Purpose and Scope of Position

Manages material needs/requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Warehousing Operations Management. Material Handlers must adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Required Competencies: Knowledge, Skills, and Abilities

• Knowledge of cGMP/FDA regulated industry
• Basic mathematical skills
• General understanding of cGMPs
• Technical writing capability
• Proficient in MS Office applications
• Inventory control and/or management
• Background to include an understanding of biology, chemistry, medical or clinical practices is a plus

Duties and Responsibilities

• Performs inventory control: cycle counts, material stocking, scrapping, at a minimum.
• Manages material expiry, allocation, kitting, and maintains material condition requirements.
• Quantifies and maintains materials in production dispensary.
• Performed apheresis receipt of incoming raw materials and prepares final product shipments for couriers.
• Maintains timing according to the production schedule to ensure on-time logistics.
• Records material handling data and information in a clear, concise, format according to proper GDPs.
• Works in a team based, cross-functional environment to complete warehousing tasks required by shift schedule.
• Must be able to work in an environment with blood derived components.
• Other duties may be assigned, as necessary. 
• Performs other tasks as assigned.
• Available to work OT when business requires.
• Flexible to work across both Summit and Warren NJ sites.
• Willing to work staggered day shift hours.

Education and Experience (As Applicable)

• Bachelor’s degree
• OR Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience.
• OR High School diploma/GED and 4 years of Manufacturing or Operations experience.

Working Conditions (US Only)

• Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. 
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Ability to lift from 25- 50 pounds.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

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.

POSITION SUMMARY:

The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, New York.  The QC Assistant Scientist Maintains and support analytical equipment in a compliant state within the QC laboratories and commercial manufacturing areas.  Performing daily performance verification activities and routine maintenance on Vi-Cell, SoloVPE and Flex analyzers. The assistant conducts routine general chemical and/or biological testing of materials and products for in-process, release and stability purposes, in compliances with all applicable procedures and regulations.  A variety of duties are performed by an Assistant Scientist relating to the efficient and effective functioning of the Quality Control lab.  This position is an integrated cross-functional team (ICT) structured position (Days) which requires rotational weekends and holidays work hours.  Additional gowning though the processing areas and maintaining clean hygiene is a requirement to control established environmental specifications.

Duties/Responsibilities:

A successful candidate for the position of Assistant Scientist I/II within the SQC organization will carry out duties in compliance with all local, state, federal regulations and guidelines including FDA, EPA and OSHA, as well as all company and site policies and procedures.  The duties a SQC Assistant Scientist will include conducting routine and non-routine testing of materials and products using a variety of equipment and test methods upon demonstrating the ability to perform and understand required methods.  Each analyst is responsible for capturing data accurately and timely followed by promptly entering testing results within the appropriate data collection system (e.g., LIMS, etc).  It is the responsibility of a member of the Quality control organization that in individual must have the ability to maintain detailed records in compliance with applicable cGMP, safety and environmental requirements.  The authoring, reviewing and modification of documents such as SOPs, protocols, investigations and other lab documents may be required.  An Assistant Scientist must maintain routine equipment and instrumentation along with performing calibrations as required to ensure instrumentation is within a compliant state.  As part of working in a laboratory setting, individuals will need to maintain inventory to ensure testing is not disrupted as well as perform routine housekeeping to ensure the lab area is continuously maintained in a safe, orderly and compliant state.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

A candidate for the  position should have:

• Ability to perform limited data analysis and data review
• An understanding of basic scientific concepts and an interest/enthusiasm for further learning.
• Basic understanding of daily lab  functions, maintenance, safety, cGMP and Standard Operating Procedures (SOPs)
• Ability to perform consistent delivery of accurate and complete experimental records
• Ability to carry out assigned laboratory work and other basic functional duties
• Ability to work under direct supervision
• Ability to perform routine data quality control checks
• Have proficiency to evaluate and interpret data
• Carry out assigned laboratory work and other functional duties
• Basic understanding of daily lab  functions, maintenance, safety, cGMP and Standard Operating Procedures (SOPs)
• Be able to consistently deliver accurate and complete experimental records.
• An understanding of basic scientific concepts and an interest/enthusiasm for further learning.

Education/Experience/ Licenses/Certifications:)

Assistant Scientist I: Minimum BS degree in scientific area with no experience (0-3 years) and be able to demonstrate theoretical understanding of scientific area of study.  Demonstrate problem solving ability, interpersonal, oral and written communication skills.  Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail. Contribute to a team based, collaborative, and positive environment, clarity of purpose and high commitment to business goals.

Physical Demands:

• Vision (Acuity, color-correction allowed.)
• Reaching (Shoulder)
• Repetitive (Use of Arm, Hands, Wrists)
• Unassisted lifting of items, not to exceed 50 lbs
• Bending/Stooping

Work Environment:

This position is indoors in a medium scale manufacturing facility and in a laboratory and requires appropriate levels of personal protective equipment (PPE). 

This role will require:

• Contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
• Powdered materials and high temperature liquids and solids may also need to be handled.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required. 
• This role also requires frequent unassisted lifting (not to exceed 50 lbs). 
• Repetitive use of arms/hands/wrists and grasping is also required.
• Depending on the work demands, office-based work requires sitting.
• This position is based indoors and you will primarily be working with others, but also independently and alone at times.

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.

Responsible for performing different parenteral manufacturing operations of highly sensitive pharmaceutical/biologics products and equipment. Performs necessary set-ups, and changeovers, equipment cleaning, and line clearance as described in the Standard Operating and Safety Policies and Procedures (SOP’s). This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.