current open positions

100% Remote Position

Duration: 12+ months

Interview: Phone

2 BAs are needed to support an SAP ERP system implementation covering the following workstreams:
1.) Manufacturing, Warehousing and Quality Management (GmP background)
2.) Planning, Procurement, Supply Chain, Master Data (GmP background and Business Process background)
3.) Finance, Product Costing, Logistics, Order to Cash (in addition to a GmP background)

Business Analyst, Business Process Delivery
Bristol Myers Squibb’s Cell Therapy business is entering an exciting new phase as it begins the commercialization of its first CAR T products. Commercialization drives new scope, scale, and complexity across the network, and requires manufacturing sites, global organizations, and IT systems to work together in new ways.
The Business Analyst is a part of the Business Delivery Support Team engaging in the global CTDP IT systems including SAP, ERP, OBIEE, and SCOPE in support of CTDO late stage clinical and commercial operations. The Business Delivery Support team, reporting to the Business Delivery Support Manager, will work directly with UAT Testing Lead, Business Delivery Managers, IT SMEs, and other delivery resources to document business use cases, user requirements, test scripts, and traceability matrices to support scalable and compliant delivery of business capabilities within assigned systems.
This Business Analysis position focuses on testing end-to-end business processes of system solutions, upgrades, and enhancements, primarily SAP ERP, and will support data transactions with non-ERP systems as needed. The position will be remote and will coordinate work with West Coast and East Coast based Team Members
Job responsibilities will include, but are not limited to, the following:
The BAs will be doing the following work:
• Collaborate with Business Delivery Team Leads and IT SMEs to build and analyze applicable use cases and user requirements to support daily operational business needs cross-functionally
• Facilitate/ Host requirements gathering workshops
• Deliverable: Use Cases and User Requirements analysis User Requirement Document (URD) (BluePrint system export)
• Work with BDTL to sequence testing (string testing) and assist in identifying what data/ infrastructure is necessary to test.
• Lead PQ activities including but not limited to planning, execution, defect management, and daily reporting.
• Schedule and support large meetings, including facilitating, preparing agendas, and taking minutes
• Liaise with IT Validation team and IT SMEs. Create supporting documentation and route for approvals.
• Deliverables: Test configuration in HP-ALM, Security matrix, Traceability Matrix
• Provide administrative support in the assigned workstream(s) such as incorporating feedback into documents and routing documents through controlled documentation system(s).
• Understand the project management process and contribute to tracking of individual progress

Required Qualifications:
• Knowledge in operations of validated GmP/GxP systems
• 3+ years of experience working in the technology/ healthcare/ or supply chain preferably as CSV specialist, technical writer, or business analyst
• Demonstrate excellent written and verbal communication
• Ability to work independently and cooperatively in a diverse group
• Attention to detail; strong communication skills, pro-active, good organization skills
• Experienced in business analysis processes including requirements gathering, requirements documentation, process flow charts, requirements traceability, PQ testing, etc.
• Strong working knowledge of MS Word, Excel (vlookup) or reporting, PowerPoint, Visio and Project Management tools
• Desire and ability to learn new software and applications quickly
• Demonstrate the ability to work in a high pace and frequently shifting environment

Preferred Qualifications:
• BluePrint, HP-ALM or electronic testing system experience
• Understanding of fundamentals of Systems Development Life Cycle and Waterfall/Agile methodologies.
• GaMP
• Proven awareness of FDA governance concerning computer system validation, regulatory compliance, GMP
• Experience in supporting major system implementations/ deployment

Location: Lawrenceville, NJ

Remote until COVID safe 

Interview: MS Teams

Job Description:

The candidate must be able to work onsite once the Work from Home policy is lifted, so local is preferred. Those not local will be considered if they are willing to relocate at their own expense. This must be noted in the comments and on their resume. Please be sure to list the city and state that the candidate currently resides in under their name on the resume.

• Evaluating business processes, performing requirements analysis and collaborating with development and implementation teams.

• Knowledge in Clinical operation space focused on CRO/Vendors oversight and contracts management process area.

• Prior experience of working within an agile team.

• Exceptional analytical and conceptual thinking skills.

• Working knowledge of Design Thinking (i.e. Contextual inquiry)

General Information      

Strong skills in building and maintaining successful relationships with key leaders across a single functional area to ensure IT projects are supported and successfully delivered.

• Evaluating business processes, performing requirements analysis and collaborating with development and implementation teams.

• Leading ongoing reviews of business processes and developing optimization strategies.

• Organizes and presents ideas in a convincing and compelling manner.

• Persuades and influences others with effective verbal and written communication.

• Understands the value of process-centric approach to business analysis and capability development.

• Effectively communicating insights and plans to cross-functional team members and management.

• Develops or modifies moderately complex information systems documentation and conveys this information to technical team for translation into technical requirements or implementation into COTS technologies.

• Identifies process, technology and organizational role changes necessary to support business goals and objectives.

• Experience in leading business process re-engineering efforts for at least one medium-to-large software project.

• Ensuring solutions meet business needs and requirements.

• Assist with user acceptance testing activities.

Business Analyst Requirements:

• MS/BS in Science, Engineering, Information Management or related field is highly desirable.

• Knowledge of SaaS application relevant towards Global Clinical Development Operations

• Knowledge in Clinical operation space focused on CRO/Vendors oversight and contracts management process area.

• A minimum of 5-7 years experience as Business Analyst or a related field.

• Prior experience of working within an agile team.

• Exceptional analytical and conceptual thinking skills.

• The ability to influence stakeholders and work closely with them to determine acceptable solutions.

• Advanced technical skills.

• Excellent documentation skills.

• A track record of following through on commitments.

Location: Lawrenceville, NJ

Remote until COVID safe

Job Description:

Top Skill: 2 to 3 years’ Solution Architect experience with at least 4 years of prior Technical Lead experience -Preferably pharma background

Solution Architect supporting Enterprise Architect for Global Product Development and Supply (GPS) accountable for the IT enterprise landscape and strategy for functions which include: Global Supply Chain, Global Engineering/Facilities, Manufacturing Operations (Biologics, Pharmaceutical Operations, Cell Therapy), Product Development, and Global Quality.
 

The positions main responsibility will be to provide solution architecture and technical oversight to Global Product Development and Supply (GPS). The candidate will be responsible for providing overall technical management, but also be able to take responsibility to document the architecture, including conceptual, logical, data, and solution for projects.
 

Position Responsibilities
• Ability to lead and/or develop conceptual, logical and solution architectures across application, data and technology domains
• Ability to review project deliverables, including design document review, for completeness, quality, risk and compliance with established project architecture standards, enterprise standards, and business vision and expected outcomes
• Ability to define and present the architecture, e.g. conceptual, logical, data, and solution, including dependencies, to an architecture review board
• Experience designing and overseeing the implementation of solution designs, including solution integrations
• Experience in interacting with development teams, communicating design and overseeing technical implementation and deployments
• Ability to coordinate and work with multiple teams to successfully implement a solution, including, but not limited to, Integration teams, Data Architecture team, vendors and/or solution development team
• Ability to identify, document, communicate and resolve/mitigate design and system development risks and issues
 

Position Requirements
• 2 to 3 years’ Solution Architect experience with at least 4 years of prior Technical Lead experience
• Experience working with cloud technologies and architectures
• Proven analytical skills to properly turn requirements into solution architecture the meets business outcomes
• Proven analytical skills to properly evaluate vendor solution architecture
 

• Good understanding of master data strategies, data lakes, and information hubs
• Experience across domains: Security, Network, Infrastructure, Data, and Cloud solutions
• Ability to clearly communicate architecture decisions, risks and benefits to all levels of the business.
• Ability to work within a project team
• Able to manage technical activities for a cross functional technical team.
• Strong presentation, verbal and written communications skills
• Must exhibit ability to be collaborative and results oriented
• Ability to work independently
• Knowledge of EA methodologies, standards, practices, governance and reference patterns is a plus

Location:  Princeton, NJ

    Job Description:
• Oversee, Prepare, and/or Review aggregate safety review documents (eg, DSUR, PBRER) and safety sections of relevant clinical trial documents (eg, protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
• Lead the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
• Lead safety activities and benefit-risk strategies for assigned BMS compound(s)/ program and chair the product SMT(s) as required.
• Assist the team and senior management in all forms of issue management and crisis management

Location: Princeton , NJ

    To perform the duties of this job, the candidate must have:

- Experience in cross functional project management (preferably CMC)
- Familiarity with end to end CMC drug development with an understanding of critical milestones and typical bottlenecks
- Ability to develop strong collaborative working relationships with stakeholders and across technical functions to drive efficient execution of CMC program strategy
- Strong organizational, interpersonal & communication skills, be agile, display an enthusiastic and collaborative attitude with peers and team members
Scope:
The Senior CMC Project Manager is closely partnered with the CMC Team Leader to enable effective development and execution of integrated CMC strategy and plans.
The scope of responsibilities of the Sen. CMC Project Manager fall into 5 general categories which flex across all drug modalities, disease areas and stages of development:
 

- Cross-functional CMC team Management, including meeting planning, facilitation and documentation
- Integrated CMC Project Plan Management, including maintenance of up-to-date project timelines and timeline scenario planning
- Gaps Analysis and Risks Management
- Planning and allocation of CMC drug material demand for non-clinical use
- Ensure accuracy of PM-related information in established portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management
 

Project Manager Job Description:
- CMC PM is a leader, coordinator, and facilitator for the Portfolio Strategy and Integration (PSI) organization , providing tactical direction, managing teams, and providing tactical solutions that support the overall program strategy developed by the Integrated CMC team
- CMC PM is expected to manage 4-5 development assets (actual number determined by level of project complexity and candidate experience) and drive execution of program strategy by fostering communication and integration of all functional area representatives on the integrated CMC development team
- Establish strong partnership with CMC Team Leader to shape the overall strategy and ensure successful execution of early to late stage programs in product development portfolio the comprises of small and large molecules
-Facilitate cross-functional CMC team meetings using meeting management best practices to drive timely and effective decision-making and successful execution of program objectives
-Create and manage all integrated CMC meeting logistics including the creation of clear and concise meeting minutes that are shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team
-Responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy
-Leverage established portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management. Examples of these tolls include (CMC Database, OnePager Pro, MS Project, ePlan/Planisware, DOI Tool, Right First Time Scorecard, Operational Risk Management)
- Work collaboratively with the CMC team Leaders and functional leaders to track the critical operational aspects of the program(s), including monitoring key deliverables, decision points, demand planning, and critical path activities to drive delivery of project objectives which roll up to the Product Development BOW
-Responsible for contributing to the definition and execution of risk management strategies, contingency planning, supporting the development of a high performing team(s), and communication of the solutions to management
-Partner with the CMC team Leader to facilitate the management of risk by scheduling meetings with the CMC teams as appropriate
- Coordinate and ensure appropriate allocation of drug substance and API materials for non-clinical use.
Experience / Qualifications:
• Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience, Masters’ degree or PhD with a minimum of 3-5 years of relevant experience
• Highly motivated self-starter that works well both in teams as well as independently
• Strong project management, business process management, and optimization skills
• Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment
• Demonstrated ability to accomplish results and meet deadlines and commitments
• Strong interpersonal and communications skills, both oral a written
• Demonstrated analytical and logic skills with a focus on fact-based decision-making
• Demonstrated proficiency in MS Project, PowerPoint, Excel and Word
• Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement
• Experience developing and/or managing program management tools to forecast budgets, timelines and resources preferred

Location: New Brunswick, New Jersey

  MATLAB, Bioinformatics background

The Immunology Quantitative Systems Pharmacology (QSP) group is searching for a highly motivated scientist to develop and apply innovative translational modeling & simulation approaches in the Immunology disease area. QSP models are mathematical models that are used to integrate knowledge and data on disease pathophysiology and drug pharmacology in a mechanistic manner.

This enables hypothesis testing and generation in target discovery, translational pharmacology and clinical drug development. This position is an exciting opportunity to broadly impact critical decision making in the progression of multi-target drug R&D in Immunology. The successful scientist will be working on a highly stimulating and collaborative environment with biologists, clinicians, pharmacometricians, translational medicine scientists, and in-house QSP modelers.

Position Responsibilities:
• Drive development and application of novel QSP Immunology models to facilitate back-translation efforts from internal late development programs.
• Function as part of team to develop and rigorously assess the functionality, feasibility, efficiency and validity of new models.
• Conduct extensive literature review to identify suitable mechanistic elements, interactions, rate constants and sub-modules for incorporation into larger systems (pharmacodynamic & efficacy) models.
• Leverage algorithms for parameter optimization and sensitivity analysis.
• Analyze model predictions and identify suitable strategies to resolve issues (whenever occur) pertaining to model performance and inaccuracy.
• Network as appropriate with experts in Translational Medicine, Discovery Biology, Clinical Development, and other groups to share learnings that maximize the translational value of QSP modeling.
• Participate in internal scientific (QSP-related) discussions.
• Build and maintain QSP expertise through a personal track record of publication, attendance/participation in conferences, scientific workshops, etc.

Degree requirements:
Ph.D. in Engineering, Mathematics, Bioinformatics, Pharmacometrics, Systems Biology/Pharmacology or a related field with a proven record of productivity as demonstrated by publications and conference presentations.

Key Competency Requirements:
• Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs).
• Experience in building, validating and using QSP models or deterministic models of biological pathways/systems to support basic science and/or translational clinical research would be particularly desirable.
• Excellent oral and written communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial and collaborative attitude.
• Hands-on experience with modeling software like MATLAB is required.
• Experience with general programming and data analysis tools/languages such as R would be particularly desirable.
• Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistic disease/pharmacology models.
• Good understanding of the basic principles of pharmacokinetics and pharmacodynamics.
• Candidates with previous (academic or industry) experience in QSP or a closely related field are highly encouraged to apply.

Location: Lawrenceville, New Jersey

• Support Regulatory CMC Biologics & Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.

Qualifications:

• Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical   development or QA, with a minimum of 5 years of Biologic/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
• At least a bachelor’s degree required. Master’s Degree or PhD preferred

Skills/Knowledge Required:
• Extensive experience with Biologic/Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
• Experience with CMC regulations for biological compounds
• Experience with Gene/Cell/CAR T Cell therapy CMC regulations
• Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
• Practical knowledge of rest of world post approval guidelines
• Have a solution-oriented approach to problem solving
• Expertise in the drug development process and post approval activities
• Ability to work on complex projects and within cross-functional teams

Location: Summit, New Jersey

Many of our job opportunities  are at client site. Datasoft Solutions offers  outstanding benefits  and a great working environment. If you feel you have a skill set Datasoft can utilize , please send your resume to:   HR@DataSoftSol.com

Datasoft Solutions, LLC is an Equal Opportunity & an "e-Verify" company.