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  • Compounder III (2nd Shift)

    Accupac 4.0company rating

    Accupac job in Lakewood, NJ

    Job Title: Compounder III Shifts: 2 nd Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products. But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all. We value detail-oriented professionals who thrive in a clean, process-driven manufacturing environment. As a Compounder, you'll play a key role in producing high-quality products that meet exact specifications while ensuring safety and compliance every step of the way. What We Offer: Competitive Pay Hourly Pay: $25.00/hr - $33.00/hr o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role. Employees are eligible for the following benefits: o Medical, Dental, and Vision insurance o Health Savings Account o Life Insurance with Optional Supplemental Plan o Pet Insurance o Short-Term Paid Disability o 401(k) Retirement Plan with Vested Company Match Contribution o Paid Time Off (PTO) o 10 Paid Holidays o Health Advocacy Programs Career Growth What You'll Do: Compound bulk products by following written batch instructions and safety guidelines Clean, sanitize, and set up manufacturing equipment for production runs Verify raw materials, equipment readiness, and compliance before starting batches Record batch data and logbook entries accurately and consistently Collaborate with Quality Assurance for product sampling and approval Support unloading and preparation of bulk storage tanks Perform daily system monitoring, DI water sampling, and routine equipment upkeep Conduct minor maintenance and assist with cleaning and painting tasks Follow cGMP and SOPs to ensure compliance and quality What We're Looking For: High school diploma or GED required; college coursework preferred 2+ years of experience in manufacturing or chemical handling preferred Strong understanding of SOPs, cGMPs, and safety protocols Ability to lift 50 lbs, work in confined spaces, and operate manual equipment Comfortable working with hot water, solvents, and sanitizing agents Must be able to wear a tight-fitted respirator Physically capable of repetitive tasks, working at heights, and working in dusty environments Strong attention to detail and ability to follow precise instructions Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today!
    $25-33 hourly 60d+ ago
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  • Associate Director, Medical Writing

    Jazz Pharmaceuticals 4.8company rating

    Philadelphia, PA job

    If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit *************************** for more information. Brief Description: The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program. S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs with multiple deliverables, s/he may be responsible for managing writers. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. S/He will mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs. This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role may have line management responsibilities. Essential Functions/Responsibilities Works with the cross functional team to ensure effective communication of data in the respective documents. Works with the cross functional team to ensure that communication needs for the clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical program lifecycle. Analyzes study level documents for their ability to deliver the information required by the target audience (eg, health authorities). Communicates proactively and efficiently within the MW team and across R&D. Ensures quality of medical writing deliverables and that work on assigned projects adheres to departmental procedures / practices, and industry / international standards. Possible oversight of contract medical writers to ensure efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines. Collaboration and strategic partnership with cross functional team members to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives. Required Knowledge, Skills, and Abilities Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness. Clear understanding of lean authoring for clinical regulatory documents. A solid understanding of the clinical development process, including the documents that are required at each stage. For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required. Prior contribution to, and an understanding of, global submissions. Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates. Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities. Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Ability to think strategically; demonstrated negotiating skills and resourcefulness. Demonstrated ability to manage several projects simultaneously. Ability to critically analyze and synthesize complex scientific information. High degree of influencing skills in shaping and developing content and wording. Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals. Successful track record of leading complex clinical / regulatory writing projects. Demonstrated ability to make decisions even in the absence of complete information. An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP). Excellent organizational and time management skills and attention to detail. Required/Preferred Education and Licenses BA/BS with at least 8 years (or advanced degree with at least 5 years) writing experience in the pharmaceutical industry across therapeutic areas required. Advanced degree preferred. #LI-DM1 Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $154,400.00 - $231,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: *********************************************
    $154.4k-231.6k yearly Auto-Apply 5d ago
  • Principal Biostatistician

    CSL Behring 4.6company rating

    King of Prussia, PA job

    CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables Main Responsibilities: Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions. Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation. Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan. Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA) Be responsible for interpreting analysis results and ensuring reporting accuracy. Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality. Be accountable for the TFL/CDISC package for study report and regulatory submission. Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations Qualifications and Experience Requirements: PhD or MS in Biostatistics, Statistics 7+ years or relevant work experience Experience with CROs (either managing a CRO, or having worked in a CRO) Experience providing statistical leadership at a study level Demonstrated statistical contribution in facilitating and optimizing clinical development #LI-HYBRID Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!
    $83k-118k yearly est. Auto-Apply 2d ago
  • Director, Clinical Trial Feasibility & Site Intelligence

    Jazz Pharmaceuticals 4.8company rating

    Philadelphia, PA job

    If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit *************************** for more information. The Director, Clinical Trial Feasibility & Site Intelligence is responsible for developing and overseeing strategic feasibility and site intelligence processes to inform clinical trial planning and provide clinical trial sites across the Jazz clinical trial portfolio. The role is responsible for process and resources that leverage cross functional expertise, analytics and data-driven insights-both historical and predictive-to inform protocol design, site and country selection. This role will be key in delivering feasibility insights and study placement strategies to support clinical study design and planning. They will lead the development of study scenarios through robust cross-functional analysis by integrating expertise and data sources to enhance country and site selection. Overall, the role is critical to driving data-informed, efficient, and scalable clinical trial planning strategies. Essential Functions/Responsibilities Provide strategic leadership of the global Clinical Trial Feasibility & Site Intelligence function, ensuring operational excellence across relevant activities. Accountable for processes and resources to enable study scenario and plans development informing study timelines and budgets through robust cross functional assessment of country and site footprint, enrolment rate and site activation projections Deliver complex feasibility insights and study placement strategies as an input to study design and operational planning, participating in study team or leadership discussions to inform key clinical trial planning decisions Drive accelerated site identification and selection through process and project leadership to define site identification strategy that aligns with study requirements Develop, implement and oversee strategic feasibility and site intelligence processes, leveraging both historical and predictive data to optimize protocol design, country and site selection through assessment of operational risk. Identify, assess, and integrate cutting-edge technologies and data sources (e.g., real-world evidence, EMR/claims data, AI/ML tools, geo-mapping, patient registries) to improve accuracy and efficiency of feasibility planning and site targeting. Evaluate ROI and impact of new tools, vendors, and feasibility approaches on cost, speed, diversity, and data quality; make recommendations to scale those that provide measurable value. Establish and monitor KPIs and operational metrics for country and site quality across studies, using insights to inform process improvements and executive reporting. Provide cross functional leadership building effective partnerships with key functions including Clinical Operations, Clinical Development, Medical Affairs, to ensure feasibility insights are embedded into study design and execution strategies. Manage and develop a high-performing feasibility team, including hiring, coaching, and resource planning across therapeutic areas and global regions. Functional oversight of CRO and vendor partnerships supporting feasibility, including governance oversight, performance management, and contract and budget management. Act as a strategic advisor and Subject Matter Expert (SME) on feasibility, enrolment optimization, and site intelligence across the organization and industry forums. Required Knowledge, Skills, and Abilities At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive Experience in the development and implementation of global clinical trial process and change management activities Proven success in strategic leadership of global site identification process, with expertise in data driven site selection across regions and therapeutic areas. Advanced expertise in global clinical trial feasibility assessment, enrolment modelling, and operational clinical trial execution. Experience integrating historical or real-world data sources and digital technologies to enhance inform study planning decisions and optimize study timelines and budgets with experience in assessment or utilization of AI LLM preferred. Demonstrated ability to lead and develop a high performing team, manage complex projects, and drive cross-functional decisions through data driven discussions. Proven Cross Functional Leader, able to build effective cross organizational partnerships with key functions including Clinical Operations, Clinical Development, Medical Affairs Demonstrated functional oversight of CRO and vendor partnerships supporting SSU, including governance oversight, performance management, and contract and budget alignment. Strong understanding of vendor and budget management, with experience measuring ROI of feasibility-related investments and initiatives. Experience with inspection readiness and continuous process improvement initiatives. Required/Preferred Education and Licenses Bachelor's degree in life sciences or related field required; advanced degree preferred. 15+ years of experience in clinical research, with 5+ years in leadership roles within feasibility or site intelligence #LI-Remote #LI-DM1 Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $189,600.00 - $284,400.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: *********************************************
    $189.6k-284.4k yearly Auto-Apply 5d ago
  • Director, Epidemiology

    CSL Behring 4.6company rating

    King of Prussia, PA job

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite. Responsibilities: • As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives. • Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports. • Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests). • Lead structured benefit-risk assessments, using qualitative and quantitative methods. • Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company. • Assist the head of department to facilitate ongoing development and growth of the department. • Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. Qualifications: • Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry. • Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard. • Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity. • Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting. • Demonstrated experience leading organizational process improvement or change management initiatives. • Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities. #LI-HYBRID About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $56k-110k yearly est. Auto-Apply 2d ago
  • Executive Director, Enterprise Infrastructure & Digital Core

    CSL Behring 4.6company rating

    King of Prussia, PA job

    Title (Business Title): Executive Director, Enterprise Infrastructure & Digital Core Business/Functional Unit: I&T The Executive Director, Enterprise Infrastructure & Digital Core is responsible for all aspects of the digital core. At CSL, the digital core is the technology foundation that supports all aspects of CSL's business including cloud computing, networking, voice, and hosting. This role plays a pivotal role in driving the modernization and innovation of CSL infrastructure ecosystem to provide flexible, scalable platforms that can streamline data flows and integrate seamlessly with cloud services and other technologies. Working closely with the technology office, they will set priorities and standards, drive development and implementation, and manage strategic partners to ensure the digital core meet CSL requirements as it relates to robustness, security, reliability, scalability, consistency, and cost effectiveness. The leader will manage a team of IT professionals and collaborate with cross-functional teams, such as cybersecurity, identity governance and enterprise systems. They must stay abreast of emerging technologies and industry trends to identify opportunities for digital growth and improvement, fostering a culture of continuous innovation and efficiency. They must demonstrate effective communication and strategic planning skills as this leader must be able to articulate the digital vision to stakeholders and drive initiatives that enhance performance and customer experience over time. Reporting Relationships: Reports to: SVP, Infrastructure, Cybersecurity, & End User Services & CISO Direct reports: Team of 4-6 senior level independent contributors and senior leaders. Main Responsibilities and Accountabilities: Strategic Leadership and Technical Acumen Develop, execute, and continuously evolves a comprehensive digital core strategy that aligns with the CSL's mission and objectives. Set the mission, vision, and strategy of the Digital Core Delivery area to maximize the success of business and technology initiatives and transform the company's infrastructure to a modern, scalable, and efficient environment. Lead and inspire a large team of technical professionals, foster a culture of innovation, collaboration, and excellence. Conceptualize and oversee the development of curriculums to upskill the team as needed as the company transforms its digital core aimed at developing full stack intelligence technical professionals. Set priorities and provide effective budget management ($100M) for the Digital Core Delivery area. Stay abreast of and introduce innovative, differentiating capabilities that enhance CSL digital agenda and competitive capabilities. Foster and maintains strategic, relationships with external vendors, service providers, and other key providers. Maintain industry relationships; may be required to speak at or support industry or strategic partner lead conferences. Coach team to set and achieve individual development goals that support the strategy, providing meaningful developmental experiences to include formal training opportunities and stretch assignments. Cloud, Hosting and Network Management Oversee the deployment, management, and optimization of cloud and hosting solutions to ensure scalability, reliability, and security. Ensure seamless integration of cloud services with on-premises systems and applications. Drive the adoption of cloud-native, future-ready technologies and best practices to support application migration, CSL's data fabric and analytics. Drive automation across the digital core aimed at efficiency and reduction of incidents and related outages. Manage and optimize the company's network environment to support high availability, monitoring and observability, and performance, and security. Ensure robust network monitoring, observability, and automation across the digital core. Local and Regional Delivery and Operations, Manufacturing and Plasma Center support Oversee technology delivery and support for local corporate offices, manufacturing sites, plasma centers and affiliates. Ensure consistent and efficient IT service delivery across all locations. Implement standard operating procedures and best practices for IT support and operations. Work closely with the manufacturing automation and plasma center support team to ensure the digital core meet the unique needs of these business areas. Modernization and Technical Debt Reduction Identify and drive reduction of areas of technical debt within the company's infrastructure and legacy data centers. Lead initiatives and projects to modernize legacy infrastructure components and related systems. to improve efficiency, reduce costs, and enhance agility. Service Provider Management Oversight of Managed Service Providers to ensure service level management (SLA) and Experience Level management (XLA) metrics are consistently met. Position Qualifications and Experience Requirements: Education Undergraduate degree in Information Technology, Computer Science, or a related field preferred. Related certifications, and advanced graduate studies desirable. Experience 15+ years' experience in the pharmaceutical/biotechnology industry. Experience in regulated manufacturing environments would also be a good candidate. Strong interpersonal skills to quickly build rapport and credibility with CSL leaders and key external stakeholders. Track record of leading infrastructure transformation and modernization initiatives. Strong understanding of cloud technologies, network management, and IT operations. 7-10 years' experience leading and managing teams in a 24x7 international environment and with cross-functional teams. Strong Project management, technical change management, and use of agile methodologies experience. Knowledge of cybersecurity best practices and compliance requirements. Competencies Excellent writing and oral communication skills; critical thinking and innovation; ability to convey risk to cause appropriate action. Thinks beyond and incorporates external factors into business strategy. Builds bridges and empowers One-CSL teams. Unleashes outcomes and creates an environment of decision making and appropriate risk taking Ignites agility and creates a nimble environment. Inspires the future and drives the strategy throughout the organization. Cultivates talent and takes proactive steps to secure future talent Minimum requirements and flexible working hours will be considered as related to our EEO policy. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $77k-133k yearly est. Auto-Apply 2d ago
  • Senior Director, Project Mgt Office

    CSL Behring 4.6company rating

    King of Prussia, PA job

    Lead the Project Management Office for R&D Main Responsibilities & Accountabilities ••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues. Qualifications & Experience Requirements •12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $79k-116k yearly est. Auto-Apply 5d ago
  • Associate Director, Biostatistics

    CSL Behring 4.6company rating

    King of Prussia, PA job

    The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. ( Positions available supporting multiple Therapeutic Areas available ) Main Responsibilities: Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents. Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations. Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA) Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP. Support or lead improvement initiatives within the department, organization and/or pharma industry. Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge. Education and Experience: PhD with 8 years of experience or MS with 11 years of experience in drug development Experience providing statistical leadership at compound/indication level Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy Solid experience in applications of advanced statistical methodologies Leading roles in regulatory submissions Experience in interactions with major regulatory authorities preferred Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred Track record of innovation preferred Competencies: Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English) Good working knowledge of SAS and/or R Expertise in a range of statistical methodologies Demonstrated use of innovative / creative methodology for analysis of clinical data Familiarity with relevant regulatory guidance documents Expertise in: CDISC, statistical programming, and/or data standards Biostatistics and Statistical Programming Operations About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $115k-166k yearly est. Auto-Apply 3d ago
  • Multi-Specialty Account Manager - State College, PA

    Lundbeck 4.9company rating

    State College, PA job

    Territory: State College, PA - Multi-Specialty Target city for territory is State College - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Warren, Huntingdon, Bloomsburg, Bradford. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! We are seeking a dynamic and results-driven sales professional with a proven track record of success who is looking to grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be successful promoting our products to stakeholders in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management where applicable. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually Self-starter, with a strong work ethic, tenacity, and outstanding communication skills Adaptability: Ability to embrace change and work collaboratively in a fast-paced team environment. Problem-Solving: Proven analytical skills to identify solutions and overcome obstacles. Data Analysis: Strong computer and technical skills used in analyzing data to develop both short- and long-term goals aligned with business objectives. Must live within 40 miles of territory boundaries Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck Ability to lift, bend, push, pull and move items including, but not limited to equipment, pharmaceutical samples, and any other work-related materials up to 25 lbs. with or without reasonable accommodation. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Recent documented successful experience selling to general practitioners (GPs) and primary care centers. Prior experience promoting and detailing products specific to CNS/neuroscience Previous experience working with alliance partners (i.e., co-promotions) TRAVEL: Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range $108,000 to $125,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
    $108k-125k yearly 5d ago
  • Senior Manager US Advertising & Promotion Lead

    CSL Behring 4.6company rating

    King of Prussia, PA job

    CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional Position Purpose Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties. Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance. Adhere to related SOPs and work instructions for established MCC/PRC processes. Main Responsibilities and Accountabilities Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations. Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL's commercial success. Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes. Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas. Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45. Maintain technical biologics/medical knowledge for assigned therapeutic areas. Actively contribute to the global CSL regulatory community through designated projects and assignments. Review and advise product development teams on communication strategies or tactics regarding investigational products. Experience Bachelor's Degree Life Science Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience. Skilled in implementing regulatory science and monitoring enforcement trends. Ability to read and comprehend product-related technical and medical information. #LI-HYBRID About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $91k-138k yearly est. Auto-Apply 2d ago
  • Manager, Global Reporting & Business Intelligence

    CSL Behring 4.6company rating

    King of Prussia, PA job

    The Opportunity: In this role, you will work closely with the Director to oversee the design, implementation, and management of data analytics and performance reporting systems. You will be responsible for collaborating with multiple departments and providing actionable insights to support decision-making to improve operational and commercial outcomes. The Role: Oversee the creation and maintenance of performance dashboards and reports to track KPIs across commercial functions like Pricing or Sales Operations Collaborate with cross-functional teams to ensure data needs are met and insights are communicated effectively to support decision-making. Ensure data quality, governance, and integration from diverse internal and external sources for unified reporting. Lead BI projects, managing timelines, deliverables, and alignment with business objectives. Implement predictive analytics and advanced reporting techniques to provide actionable insights for business strategies. Provide mentorship and guidance to BI team members, promoting continuous improvement and innovation in reporting practices. Ensure compliance with regulatory requirements in all data management and reporting activities. Your skills and experience: Bachelor's or master's degree in computer science, Information Management, Math, Statistics, or a related field 3-5 years of experience in relevant analytics roles and prior BI/reporting team lead experience preferred Experience with pharmaceutical industry data sources (e.g., IQVIA DDD / Midas, Claims, LRx / Dx) is required Strong analytical as well as BI tools (Tableau, Power BI, Qlik etc.) experience preferred. Experience with regulatory compliance related to data privacy and protection. Exceptional communication and interpersonal skills, with the ability to actively engage and influence partners at all levels. Excellent leadership and team management skills, with the ability to inspire and develop impactful teams About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $82k-107k yearly est. Auto-Apply 1d ago
  • Senior Director, Cardio & Renal Statistics Lead

    CSL Behring 4.6company rating

    King of Prussia, PA job

    CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional collaboration. Key Responsibilities Lead the Biostatistics function for the assigned Cardio and Renal Therapeutic Area (TA), with accountability for statistical deliverables across all stages of clinical development. Provide statistical thought leadership to Clinical Development teams in the design of clinical development plans, and clinical trials, ensuring robust methodology and alignment with program objectives. Partner with Therapeutic Area (TA) leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions. Ensure high-quality statistical input into study protocols, analysis plans, clinical study reports, and regulatory documentation. Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and contribute to preparation of statistical content in submission dossiers. Champions the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks (e.g., Go/No-Go criteria, assurance). Collaborate with other functions (e.g., Epidemiology, Safety) on initiatives such as real-world evidence and patient safety analysis. Manage, develop, and mentor statisticians within the therapeutic area to build technical capabilities and ensure delivery excellence. Build relationships and oversee external vendors and CROs to ensure quality and compliance with timelines and standards. Contribute to departmental strategy, process improvement, and the advancement of statistical methodology and operations. Qualifications and Experience PhD in statistics or related field 10+ years of experience in clinical development within the pharmaceutical or biotechnology industry Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions Experience partnering with cross-functional teams and interacting with health authorities People management experience required; mentorship and team-building strongly preferred Experience managing external partners (CROs, consultants) Exposure to or leadership of statistical innovation initiatives preferred Competencies Strong statistical methodology knowledge and clinical trial design expertise Ability to collaborate and influence across functions and levels Excellent communication and interpersonal skills Experience with CDISC standards, programming oversight, and statistical operations Strategic and analytical mindset with a focus on execution Ability to work in a matrixed environment and lead through influence About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
    $122k-180k yearly est. Auto-Apply 2d ago
  • Entry Level Phlebotomist

    Biolife Plasma Services 4.0company rating

    Camp Hill, PA job

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. This position will require 6-8 weeks of travel for training purposes. All travel expenses for training will be covered by the company and will include cost of flights, rental car, lodging, and meals. Travel home for the weekend may be permitted and can be discussed further in the interview process. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - PA - Camp Hill U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - PA - Camp HillWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No
    $16 hourly Auto-Apply 4h ago
  • Director, BD&L Forecasting

    CSL Behring 4.6company rating

    King of Prussia, PA job

    The Opportunity: Reporting to the Senior Director of Global Forecasting & Portfolio Analytics, you will lead the BD&L forecasting and Analytics for Cardiovascular and Renal (CVR) and Transplant and Immunology (T&I) therapy areas In this role, you will drive decision-making across all BD&L due diligence efforts via commercial revenue forecasting for both pre- and full-fledged due diligence workstreams and represent Insights & Analytics (I&A) forecasting within the commercial due diligence team You will be expected to follow all CSL I&A forecasting standards, ensuring accuracy and alignment with business stakeholders You will be the primary point of contact representing I&A forecasting for maximization and special projects across the CSL portfolio This role would require strong consultancy orientation and the ability to communicate effectively and efficiently with all organizational stakeholders. As a part of the Global I&A team, you will play a pivotal role in shaping our strategic direction and optimizing our pharmaceutical portfolio. The Role: Lead end to end forecasting & analytics efforts for all business development workstreams at CSL for CVR and T&I Would include conducting high level assessments for early research stage assets as well as deep dive commercial assessments and valuations for late-stage opportunities or a mix of both Would need prior experience with conducting and validating market research and competitive landscape analysis along with thoughtful incorporation into BD&L forecasts Would need the ability to plan, execute and deliver multiple time sensitive projects with both accuracy and speed under tight timelines Leverage internal forecasting standards and triangulate inputs from R&D, Commercial Development, Market Research, Competitive Intelligence, Pricing & Access, Legal/IP to create robust and defendable forecasts/scenarios Represent Forecasting and Portfolio Analytics function within commercial due diligence team, providing critical insights and analysis to support strategic decisions. Collaborate with cross-functional teams to integrate data-driven insights into strategic planning, commercial strategies, and decision-making processes. Oversee the analysis of market trends, competitor landscapes, and emerging technologies to identify opportunities and risks for business growth. Provide leadership in the evaluation of potential partnerships, licensing agreements, and M&A opportunities by delivering data-driven insights. Stay updated on industry trends, regulatory changes, and advancements in forecasting and analytics methodologies within the biotech and pharmaceutical sectors. Support to ensure strategic fit of opportunities coherent with CSL TA strategy Drive continuous improvement in BD&L forecasting capabilities within the Forecasting COE, including identification of talent gaps and develop training programs to enhance team capabilities Qualifications: Minimum of a bachelor's degree with preferred focus in a scientific or business field (finance, analytics, economics, analytics/statistics or related). Post-graduate qualifications preferred 10+ years' experience in the pharmaceutical/biotechnology industry working across multiple therapeutic areas 6+ years of experience running/leading forecasting teams in biotech/pharma industry Hands on expertise with all forecasting techniques including time series modeling and statistical trending algorithms, patient-based/TRx modeling Experienced in multiple forecasting & BI tools including but not limited to Forecast Pro, @Risk or other monte-carlo simulation tools, Tableau, QlikSense etc. Experience with conducting detailed literature reviews for Epidemiology as well as expertise & thoughtful utilization of available datasets such as Oracle DB/Legacy Kantar, Datamonitor, Evaluate, Globaldata, IQVIA, Symphony, ADIVO, GERS, UNOS etc. Experience working with Rx, patient claims, pricing (WAC) and managed markets data sources (e.g. IQVIA, SHS, MMIT, Komodo, Clarivate, IPD Analytics) Strong interpersonal skills to quickly build rapport and credibility with organization leaders and key external stakeholders Extensive experience leading planning cycles in commercial, forecasting, or analytical roles This is a hybrid position out of our King of Prussia offices. You must be in the office 3 days a week and one of the days must include a Monday or Friday. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!
    $56k-110k yearly est. Auto-Apply 1d ago
  • Project Controller II

    IPS-Integrated Project Services 4.3company rating

    Blue Bell, PA job

    At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Project Controller II (Cost) to join our talented team at one of our offices located in Blue Bell, Pennsylvania, Somerset, New Jersey, Emeryville, California, or Irvine, California. Project Controller II will support all phases of the project costs and schedule reporting using the most current industry practices and software. Work under the supervision of Senior Controllers, Project Managers to integrate with engineering, procurement, cost, schedule, technical &construction disciplines for seamless reporting to insure effective Capital Project Delivery. Position Responsibilities Assist and support processes for project budgeting, invoicing, change control and cost forecasting for the entire engineering, procurement, construction and qualification (EPCQ) life cycle. Work in a highly collaborative and dynamic project environment. Assist estimating, procurement and project management on project scope coordination, work package definition, contract development and bid analysis as directed Support project team to agree contractor SOVs and certify progress, invoicing & payment. Follow-on support with accounting to ensure alignment of project forecast with current funding and billings to client. Insure appropriate back-up documentation for all phases. Actively support the change control process. Assist with cost trends & changes with follow-on validation &agreement of pricing. Process CO's for approval and incorporation into contracts. Assisting operation of integrated cost reporting platform. Produce detailed cost reports, including budgets, changes, commits (POs), spends, anticipated costs and forecast. Review cost system data integrity to insure accuracy of overall project forecast. Assist with schedule progress reports, trending charts and schedule analysis. Ability to produce effective visualization, graphics & outputs for team communication. Collaborate and assist on alignment of cost & schedule data. Assist with update to projections on cash flows, staffing plans contingency usage. At project completion, record the project's historical cost information and “lessons learned” as directed. Collaborate with all groups to improve company processes, systems and intellectual infrastructure to promote organizational learning and continuous improvement. The salary offered for this role is between $76,000- $126,000 , but actual salary offered is dependent on experience, skill set and education. Qualifications & Requirements BS degree in engineering or related technical field, construction management or applicable experience. 2-5 years of professional experience. Aptitude, ability and capacity to progressively broaden knowledge of engineering, procurement, construction and qualification (EPCQ) processes in the Pharma/Biotech Industry. Strong analytical and computer skills. Experience with data management tools (MS Excel, MSAccess, PowerBI. Procore, and Oracle). Exposure to financial ERP systems is desirable. Excellent collaboration, communication and organizational skills are required with the ability to prioritize and manage large amounts of information to effectively meet deadlines. Desire to work towards PMI, AACEI or other industry certifications. Demonstrated Competencies Must strive for excellence in all aspects of job performance. Must approach work with visible enthusiasm and a contagious energy that provides a positive example for coworkers and clients. Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery systems. Must conduct oneself with an uncompromising commitment to the welfare of clients. Must act in an ethical, professional and respectful manner at all times. Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork. Must be driven to succeed and committed to goal attainment This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. IPS will not sponsor employment visas for this position. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $76k-126k yearly 4d ago
  • Senior Cost Engineer (Utilities Construction)

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Cost Engineer to join our talented team at our office located in Somerset, New Jersey. In this role, you will be assigned to projects to review, coordinate, and summarize the activities of cost control, planning and scheduling, document control, and estimating. You will also support the Project Manager in the delivery of individual projects, focusing on quality objectives and ensuring the achievement of safety objectives on assigned projects. Additionally, you will coordinate resources to achieve project goals, interact with clients on assigned projects, and promote positive relationships. Position Responsibilities Identifies and analyzes potential project problems. Develops working knowledge of prime contract requirements and applies knowledge to project activities. Coordinates review and approval from the Project Executive and/or Director of Operations, and communicates this information to the project team. Supports the Project Manager in the following: Development and maintenance of written project scopes of work and communication of this information to the project team. Development and maintenance of project schedules, including targeted and actual activity lists, durations, and sequencing logic, and communicating this information to the project team. Monitoring and reporting project costs. Development of change control documentation and related financial documentation. Coordination of safety resources to monitor site safety and correct nonconformances. Procurement and coordination of all required project resources, including intra-divisional, inter-divisional, and extra-corporate. Preparation of subcontracts, purchase orders, change control documentation, and related financial documentation. Evaluation of vendor and subcontractor invoices. Facilitating communication between project participants and producing documentation of communication between project participants. Develops a thorough understanding of contractually required quality in design and construction and supports quality assurance for the project. Supports the Financial group in the preparation of invoices to clients. Works with Document Control to ensure that all project documents are distributed, reviewed, and stored to meet project and corporate requirements. The salary offered for this role is between $100,000 and $140,000, but the actual salary offered is dependent on skills, experience, and education Qualifications & Requirements 16+ years of professional experience. Bachelor's degree in a technical field: engineering, project management, construction management. Experience in cost engineering, estimating, scheduling, and earned value management. Has a working knowledge of the project budget and identifies exceptions to the project budget throughout the execution of the project. Experience in developing and managing multiple concurrent projects and in developing and executing PMO best practices. Experience in all facets of Engineering, Procurement, and Construction Management (EPC). Professional credentialing is strongly encouraged: CCT or CCP, CST or CSP, EVP, CMIT or CCM, PMP, EIT. High level of computer expertise in multiple industry-wide software products MS Office Products Scheduling software such as Primavera and MS Project Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $100k-140k yearly 5d ago
  • Senior Construction Scheduler (Utilities)

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Construction Scheduler to join our talented team at our office located in Somerset, New Jersey. Additional Responsibilities Develops, monitors, and updates project plans & schedules encompassing the entire engineering, procurement, construction, and qualification (EPCQ) life cycle. Analyzes schedule input from project partners, including clients, internal teams, vendors, and contractors, to verify schedule durations and integrity as well as evaluate the logic and float paths. Integrates data into an overall master schedule and ensures the credibility of the information in the master schedule. Makes recommendations to manage float and (re)sequence activities to achieve project milestones/target dates. Collaborates with the team to support constructability and value engineering. Baseline schedules and document the basis for approval. Monitors schedule progress, deviations, and variances and assesses impacts on the critical/near-critical path activities. Assists in developing alternatives for corrective action. Performs job site walks to verify the physical progress of scheduled activities and analyze change orders for schedule impacts. Continually progress & review schedules with the project team to ensure accurate and timely data is incorporated and forecasted. Ability to generate earned value, SPI, CPI, and other schedule metrics. Prepares schedule progress reports, trending charts, and schedule analysis. Maintains record of scope changes, trends, and variances that potentially affect schedule performance. Collaborates with all groups to improve company processes, systems, and intellectual infrastructure to promote organizational learning and continuous improvement. The salary offered for this role is between $120,000 and $150,000, but the actual salary offered is dependent on skills, experience, and education Qualifications & Requirements Bachelor's degree in engineering or a related technical field, construction management, or applicable experience. 7+ years of experience as a planner/scheduler on facilities capital projects. Demonstrated knowledge of engineering, procurement, construction, and qualification (EPCQ) processes. Understanding of engineering and construction methodologies and technical documentation. Demonstrated expertise in the use of modern planning and scheduling principles, methodologies, techniques, and tools, including CPM, Last Planner, 4D, etc. Strong analytical and computer skills with demonstrated proficiency in Primavera P6 Planner, Microsoft Project & Office Suite programs. Preferred Qualifications Knowledge of vPlan, BIM 360, and other visual & collaborative planning tools. PMI or AACEI certification. Experience in the pharma/biotech industry. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $120k-150k yearly 5d ago
  • Contract Analyst

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Contract Analyst to join our team at our office located in -------------------Somerset, New Jersey. In this role, you will leverage extensive professional experience and skills, and can work autonomously or in a team environment. You will report to a Manager of Project Controls and administer contract and purchase order flow by departmental SOPs, policies, and project-specific requirements. You will also act as quality assurance (QA) checks on all contracts and purchase orders. Additionally, you will guide internal and external stakeholders on contract management requirements, including corrective actions to key contract elements that do not meet project and/or IPS standards. Additional Responsibilities Bid Scopes of Work: Work with the project team to prepare SOW documents to attach to the Requests for Proposals (RFP). Recommendations To Award (RTA): Prepare or assist in the preparation of RTA. Work with the Project Team to prepare this document. Conformed Scopes of Work (SOW): Draft and finalize. Change Order Management: Review change order request (COR) documents for compliance with the contract documents. Prepare all necessary documents to process change orders to purchase orders. Contract Management/Support Documentation: Draft letters or related correspondence to support adherence to contract terms and conditions. Contractor Feedback Documentation: Collect, store, and report on feedback detailing contractor performance. Participate in weekly engineering meetings between project management, project engineering, project controls, Company procurement, licensing and permitting, Company corporate properties, the Company's engineering contractor(s), and other project stakeholders. Communicate daily with the project management team, project Engineering, Company engineering contractor, and other project stakeholders. Support the project management team in assessing critical path and near-critical path work with alignment and coordination of all on-site resources throughout the construction and commissioning phases of the project. Assist in interfacing with the Company's engineering contractor and the Company's engineering department, to assess engineering deliverables and schedules, to ensure design management and coordination of all project stakeholders, with Issued for Construction (“IFC”) documents, timely resolution of Requests for Information (“RFI”), control of Engineering Change Notices (“ECN”) and red lines, and timely resolution of Non-Conformance Reports (“NCR”). Assist in the creation and management of the following: Project Scope Document and participate in the procurement of all stakeholder signatures. Project Execution Plan and participate in the stakeholder approval process. Risk Register and participate in the stakeholder approval process. Assist in the engagement of the Company's: Corporate Properties group in the project and communicate directly to ensure that the project's needs for temporary/permanent easements. Legal group in the Project and communicate directly to ensure that project needs are established and met. Applicable Division(s) in the Project and communicate directly to ensure that project needs are established and met The salary range for this role is between $140,000 and $150,000, but the actual salary offered is dependent on experience, skill set, and education. Qualifications & Requirements 10 - 15 years of professional experience in the Utility Environment. Bachelor's degree in a technical field: engineering, project management, construction management. Software skills: MS Office Products at a minimum, industry-related software products. Demonstrates project management experience. Basic working knowledge of electric distribution systems, and civil construction. Knowledge of specification and contract enforcement, applicable technical standards, OSHA, and other regulatory statutes. Knowledge of trade agreements, procedures, techniques, work methods, and standards used in the construction industry. Administrative skills for effective monitoring of contractor progress, cost control, and contractual interpretation matters. Preferred Qualifications Membership in a professional organization such as AACE, ISPE, etc. Professional credentialing (CCT or CCP, CST or CSP, EVP, CMIT or CCM, PMP, EIT). SAP experience. Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for extended periods with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $140k-150k yearly 5d ago
  • Project Engineer (Utilities Construction)

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Engineer to join our talented team at our office located in Somerset, New Jersey. In this role, you will have a technical background that aids in their development in cost engineering, scheduling, and estimating. You will work closely under the supervision/mentorship of a senior team member. Additional Responsibilities Assists in the transfer of engineering documents between the project management team, the Company engineering contractor, and other project stakeholders. Coordinates daily communication between the project management team, project Engineering, Company engineering contractor, and other project stakeholders. Ensures the creation and distribution of weekly action item lists to project stakeholders. Assists in the creation and management of the Project Scope Document, and participates in the procurement of all stakeholder signatures. Supports the preparation of presentation documents for Company Utility Review Board (“URB”) and Capital Review Committee (“CRC”) meetings. Assists in the creation and management of the Project Execution Plan and Risk Register, and participates in the stakeholder approval process. Supports the project management team in assessing critical path and near-critical path work with alignment and coordination of all on-site resources throughout the construction and commissioning phases of the project. Assists in the preparation of cost estimates at the office, study, conceptual, and definitive levels. Supports project controls personnel in maintaining the project budget, and assists in ensuring that the Work Breakdown Structure (WBS) is followed and cash flow objectives are met. Assists in the facilitation of design reviews by project engineering, Division, and other stakeholders, and ensures that everything is signed off on by the appropriate parties. Supports project engineering in the development of the Material Tracking Log (“MTL”), supports all material procurement activities, and ensures that the MTL is maintained throughout the project lifecycle. Supports the Company's IP Construction group by participating in the development of a construction sequencing plan for all work necessary for the project. Assists the project management team in assessing schedules and developing plans and strategies for ensuring the optimization of the integrated Project Schedule for all construction and commissioning activities. The salary offered for this role is between $80,000 and $95,000, but the actual salary offered is dependent on skills, experience, and education Qualifications & Requirements This is an entry-level position. Bachelor's degree in a technical field, such as engineering, project management, or construction management. Proficient in MS Office Products. Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, PMP, EIT). Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $80k-95k yearly 2d ago
  • Compounder (3rd Shift)

    Accupac 4.0company rating

    Accupac job in Lakewood, NJ

    Job Description Job Title: Compounder I, II, and III Shifts: 3rd Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products. But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all. We value detail-oriented professionals who thrive in a clean, process-driven manufacturing environment. As a Compounder, you'll play a key role in producing high-quality products that meet exact specifications while ensuring safety and compliance every step of the way. What We Offer: Competitive Pay Hourly Pay: $18.72/hr - $25.00/hr o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role. Employees are eligible for the following benefits: o Medical, Dental, and Vision insurance o Health Savings Account o Life Insurance with Optional Supplemental Plan o Pet Insurance o Short-Term Paid Disability o 401(k) Retirement Plan with Vested Company Match Contribution o Paid Time Off (PTO) o 10 Paid Holidays o Health Advocacy Programs Career Growth What You'll Do: Compound bulk products by following written batch instructions and safety guidelines Clean, sanitize, and set up manufacturing equipment for production runs Verify raw materials, equipment readiness, and compliance before starting batches Record batch data and logbook entries accurately and consistently Collaborate with Quality Assurance for product sampling and approval Support unloading and preparation of bulk storage tanks Perform daily system monitoring, DI water sampling, and routine equipment upkeep Conduct minor maintenance and assist with cleaning and painting tasks Follow cGMP and SOPs to ensure compliance and quality What We're Looking For: High school diploma or GED required; college coursework preferred 2+ years of experience in manufacturing or chemical handling preferred Strong understanding of SOPs, cGMPs, and safety protocols Ability to lift 50 lbs, work in confined spaces, and operate manual equipment Comfortable working with hot water, solvents, and sanitizing agents Must be able to wear a tight-fitted respirator Physically capable of repetitive tasks, working at heights, and working in dusty environments Strong attention to detail and ability to follow precise instructions Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today! #INDOTHER2025
    $18.7-25 hourly 9d ago

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