Senior Project Manager jobs at Takeda Pharmaceuticals U.S.A., Inc. - 1298 jobs
Senior Project Leader
Blue Cross and Blue Shield Association 4.3
Philadelphia, PA jobs
Bring your drive for excellence, teamwork, and customer commitment to Independence. Join us as we renew and reimagine the future of health care. Together we will achieve our mission to enhance the health and well-being of the people and communities we serve.
POSITION SUMMARY:
The Client Set Up and Product Operations Readiness Sr. Project Leader will be responsible for working with cross-functional teams and various levels to define and meet project requirements, deliverables related to Peak and Customer Service operational readiness and projects.Bring your drive for excellence, teamwork, and customer commitment to Independence. Join us as we renew and reimagine the future of health care. Together we will achieve our mission to enhance the health and well-being of the people and communities we serve.
POSITION SUMMARY:
The Client Set Up and Product Operations Readiness Sr. Project Leader will be responsible for working with cross-functional teams and various levels to define and meet project requirements, deliverables related to Peak and Customer Service operational readiness and projects. Bring your drive for excellence, teamwork, and customer commitment to Independence. Join us as we renew and reimagine the future of health care. Together we will achieve our mission to enhance the health and well-being of the people and communities we serve.
POSITION SUMMARY:
The Client Set Up and Product Operations Readiness Sr. Project Leader will be responsible for working with cross-functional teams and various levels to define and meet project requirements; deliverables related to Peak and Customer Service operational readiness and projects. Key areas of responsibility include planning, organizing, facilitating meetings and leading projects that support end to end operational readiness aligned with the business goals of Service Operations as well as key functional areas within Independence that support Group, Consumer and Medicare product implementations. Key functional areas include but are not limited to Medicare Product Management, Medicare Service Operations, Product Management, Regulatory Compliance, Pharmacy Services, Underwriting, Sales, etc. The Sr. Project Lead will also analyze current policies, procedures and processes to identify gaps and areas for improvement; develop work plans and timelines; create policies, procedures, control processes, develop reporting; effectively work with managers and subject matter experts from multiple functional areas for workgroups and project teams; facilitate meetings and provide trouble-shooting and problem resolution support in support of identified projects.
Responsibilities:
Independently plan, manage and coordinate activities of individuals at both the management and staff levels as well as Client Set Up Vendors (Highmark, Optum, Davis Vision, UCCD, etc.). Ensure that key goals and objectives are accomplished in keeping with established priorities, timeframes and budgets.
Coordinate inter-departmental and intra-departmental teams to develop policies, procedures, processes and programs to meet key business objectives, performance goals and regulatory requirements.
Managing contract document and relationship with vendor to ensure contractually obligated PG's and compliance items are met timely.
Develops and managesproject plans, reports on progress weekly. Manages and coordinates every phase of the project
Creates and maintains policies, desk procedures, program descriptions and training materials to ensure that programs and processes can be efficiently and effectively maintained.
Organizes and leads meetings with vendors and key functional areas. Creates presentations, agenda and minutes. Ensures timely distribution of meeting minutes to team members as appropriate.
Identifies and effectively communicates risks and issues. Develops ongoing action plans to improve performance and outcomes. Identify key gaps for which formal action plans need to be developed, works with staff in barrier analysis, action plan development, implementation, and integration of activity into centralized performance monitoring/reporting process.
Facilitates meetings, effectively develops and maintains effective business relationships with core areas within the organization.
Qualifications:
An undergraduate degree. A minimum of 3-5- years progressive employment experience in a health insurance organization and demonstrated experience in projectmanagement is required, as is the ability to effectively utilize projectmanagement software and other Microsoft office applications (Access, Word, Excel, PowerPoint).
Candidate must be able to work independently, manage multiple priorities effectively and have excellent analytical, organizational and problem-solving skills.
Proven ability to effectively interact and give direction to staff at all levels of the organization, including senior staff, is required.
Excellent verbal and written communications skills are also required.
Independence has implemented a "Hybrid" model which consists of Associates working in the office 3 days a week (Tuesday, Wednesday & Thursday) and remotely 2 days a week (Monday & Friday). This role is designated as a role that fits into the "Hybrid" model. While associates may work remotely on our designated remote days, the work must be performed in the Tri-State Area of Delaware, New Jersey, or Pennsylvania.
IBX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their age, race, color, religion, sex, national origin, sexual orientation, protected veteran status, or disability.
Must have an Android or iOS device which is compatible with the free Microsoft Authenticator app
Independence has implemented a "Hybrid" model which consists of Associates working in the office 3 days a week (Tuesday, Wednesday & Thursday) and remotely 2 days a week (Monday & Friday). This role is designated as a role that fits into the "Hybrid" model. While associates may work remotely on our designated remote days, the work must be performed in the Tri-State Area of Delaware, New Jersey, or Pennsylvania.
IBX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their age, race, color, religion, sex, national origin, sexual orientation, protected veteran status, or disability.
Must have an Android or iOS device which is compatible with the free Microsoft Authenticator app
$83k-124k yearly est. 8d ago
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Senior Manager, Order to Cash
Vertex Pharmaceuticals 4.6
Boston, MA jobs
**Job Description****General Summary:**Vertex is seeking an experienced Order to Cash professional to join our Controllership organization as a seniormanager within the Global Revenue Accounting team. The Controllership organization is integral in delivering Vertex's mission of creating transformative medicines for people with serious and life-threatening diseases. You will be working as part of a dynamic and diverse organization alongside outstanding people who are forward-thinking, collaborative and recognized leaders in their areas.The position is a key role within Global Revenue Accounting, and we are seeking an experienced and strategic SeniorManager within Order to Cash “O2C” to manage our credit control function, drive cash flow optimization, manage internal controls and implement solutions that strengthen financial performance. The successful candidate will combine hands-on credit control expertise with strategic insight, leading a team of two to maximize collections, minimize risk, and support business growth.Central to this role is fostering exceptional working relationships across the Controllership function, Global Supply Chain, our third-party logistics providers, and regional finance teams. The individual will also be well organised, comfortable presenting and influencing senior stakeholders and able to manage competing deadlines.This role is highly visible across the international organisation and with our global head office in Boston and offers excellent opportunities for personal development and continuous improvement. As Vertex continues to grow, and expand geographically, the successful candidate will have many opportunities to shape processes and drive lasting change.**Key Duties and Responsibilities:*** Work with global finance, revenue accounting, trade ops, supply chain and market access teams to ensure we remain at the forefront of any changes to our ways of working* Implement and enforce credit policies and procedures that mitigate risk while supporting customer relationships* Present credit & collections updates to Senior Directors and Departmental Heads* Build strong relationships with our external service providers, internal stakeholders and business partners* Represent the team at Global Credit Committee meetings, interacting with the Global Finance and Chief Accounting Officer's leadership team* Develop and execute credit strategies that optimize cash flow, reduce Days Sales Outstanding (DSO), and minimize bad debt* Protect Vertex's credit risk with consideration for securitisation initiatives.* Design process solutions in support of key business decisions and new product/country launches* Drive improvements in our monthly Dashboard reporting* Drive transformation initiatives (system/process/policy)* Participate in global projects representing the needs and interests of the O2C and wider Revenue Accounting team* Analyse the performance of external service providers against KPIs* Ensure our ongoing compliance to all O2C related SOX controls**Knowledge and Skills:*** Ability to work collaboratively with external service providers, to ensure the highest standards of execution are maintained and the interests of Vertex and its patient remain forefront* Strong stakeholder management skills, able to quickly establish credibility and build effective, collaborative, working relationships at all levels* Excellent communication and interpersonal skills necessary for leading cross functional projects and presenting to seniormanagement (including accounting, finance and commercial management)* Ability to partner with other functional areas to develop, improve and monitor compliance with policies and procedures including taking a leadership role on certain initiatives* Strong financial analysis and reporting skills* Strong knowledge of credit control, risk management, and regulatory compliance* Strategic thinker with ability to provide solutions to cash flow and credit challenges* People management skills, with experience motivating and developing teams* Solution-focused with experience in improving processes and systems* Ability to pivot based on demand and prioritization**Education and Experience:*** Bachelor's Degree in Accounting or Business administration, or equivalent business experience* Strong credit control/accounts receivable experience, in a managerial or leadership role* Experience in large, complex, or multinational organizations preferred* Experience in pharmaceutical industry preferred#LI-SG1#LI-Hybrid**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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$131k-172k yearly est. 3d ago
Senior Manager of Loyalty
Ascend Wellness Holdings 4.0
Chicago, IL jobs
Ascend Wellness Holdings ("AWH") is building a hands-on, customer-obsessed Loyalty organization designed to elevate the Ascenders Club into a premier brand experience. Reporting to the Chief Commercial Officer, the SeniorManager of Loyalty will serve as the architect and active working leader of this new function. The SeniorManager, Loyalty is responsible for setting strategy, driving execution, and measuring success against clear KPIs.
This leader will be in the paint, building, optimizing, and executing initiatives that strengthen customer connection, retention, and long-term loyalty while directly interfacing with executive leadership to influence enterprise priorities.
Every decision starts and ends with the Customer. The SeniorManager bridges creative strategy and analytical insight to define how Ascend connects with its most loyal customers through personalized communications, omnichannel experiences, and exclusive moments that reinforce Ascend's commitment to community and care.
Key Responsibilities
Serve as a hands-on, working leader who shapes strategy and executes in the day-to-day, ensuring progress is measured against defined KPIs for engagement, retention, and customer lifetime value.
Develop and own the enterprise loyalty strategy from concept through execution, covering program design, optimization, and innovation roadmap.
Champion the customer voice in every initiative, ensuring loyalty drives genuine connection, satisfaction, and repeat engagement.
Lead the evolution of the Ascenders Club, creating tiered, experiential benefits that deliver measurable business impact.
Act as a cross-functional connector across Brand, Marketing, Retail, Digital, and Operations, embedding loyalty into the broader customer experience and commercial strategy.
Collaborate closely with field and retail teams to bring loyalty to life at dispensary level, ensuring every in-person interaction reinforces program value and customer delight.
Translate complex data into clear, actionable insights that inform strategy, optimize campaigns, and guide investment decisions.
Monitor and report performance against KPIs, providing transparency, accountability, and proactive recommendations to the Executive Team.
Serve as a trusted advisor to senior leadership communicating insights through compelling narratives and influencing long-range planning and resource allocation.
Identify and evaluate emerging technologies, partners, and platforms to enhance loyalty innovation and future-proof the program.
Foster a continuous improvement mindset through agile testing, customer feedback loops, and analytics-driven iteration.
Drive consistent brand storytelling across all loyalty touchpoints, ensuring tone, visuals, and experience align with Ascend's premium identity.
Manage vendor and technology relationships (CRM, automation, app, or loyalty platform partners).
Perform additional projects that advance Ascend's loyalty, customer engagement, and retention goals.
Supervisory Responsibilities
Build and lead a high-performing team of strategists and experience designers, fostering a culture of innovation, accountability, and excellence.
Directly manage and mentor team members, providing coaching, feedback, and professional development opportunities.
Foster a culture of innovation, collaboration, and accountability within the team.
Partner with Human Resources to recruit, train, and retain high-performing talent within the Loyalty organization.
Qualifications & Skills
Bachelor's degree in Marketing, Business Administration, Communications, or related field; MBA or advanced degree preferred.
8+ years of experience in Loyalty, CRM, or Customer Experience roles within retail, CPG, or hospitality sectors.
Proven success as a working leader who both sets strategy and executes, delivering measurable results tied to customer KPIs.
Strong understanding of customer behavior and passion for building programs that create emotional connection and long-term advocacy.
Demonstrated ability to develop and implement omnichannel loyalty strategies that drive quantifiable business outcomes.
Exceptional analytical and storytelling skills with the ability to turn insights into action.
Hands-on experience leveraging CRM, customer analytics, and marketing automation to optimize engagement and retention.
Ability to collaborate cross-functionally with Marketing, Retail, Operations, and Technology to create seamless customer experiences.
Proven leadership in developing and inspiring teams through feedback, coaching, and empowerment. Excellent communication and presentation skills; confident engaging with executive stakeholders and board-level audiences.
High degree of emotional intelligence, adaptability, and resilience in a dynamic, growth-focused environment.
Ability to travel periodically to retail locations and member events as business needs require.
Work Environment
This position primarily performs duties in a remote office setting. This position will also be onsite in retail and manufacturing settings.
Physical Requirements
While performing the duties of this job, this position is regularly required to sit and use hand(s) to handle, grasp, feel, and/or touch. The position is occasionally required to stand, walk, and reach with hands and arms. The position is required to speak and listen regularly and may occasionally need to lift or move materials, event supplies, or equipment weighing up to 25 pounds.
Company Overview
Ascend Wellness Holdings ("AWH") is a vertically integrated cannabis cultivator, processor and provisioning center operator with assets in Illinois, Maryland, Massachusetts, Michigan, New Jersey, Ohio and Pennsylvania. We seek to foster a robust and inclusive cannabis industry through a premium, unmatched customer-focused retail experience. We are looking to build a world-class team that will help carry out our mission of helping to shape the future of cannabis as a leading healthcare solution. We are committed to improving the quality of our patient's lives by offering unrivaled quality, consistency and meticulously curated products that satisfy our customers unique, individual needs. When it comes to customer service experience, our dispensaries will set a new standard of excellence, emphasizing health and wellness by a highly knowledgeable team. A team that is committed to our values, our people, and our communities; we are looking for people who are inspired by our vision and stay dedicated to our mission as we continuously expand.
EEO Statement
Ascend Wellness Holdings, INC., ("AWH") and its subsidiaries is an equal opportunity employer and celebrate the population of differences and does not discriminate in its hiring / hiring practices, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.
Nothing in this job specification restricts management's right to assign or reassign duties and responsibilities to this job at any time. Critical features of this job are described under various headings above. They may be subject to change at any time due to reasonable accommodation or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are not intended to be construed as a complete list of all responsibilities, duties, and skills required of employees in this position.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.
To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
#LI-REMOTE
$87k-130k yearly est. 8d ago
Senior Project Manager
Bristol Myers Squibb 4.6
Phoenix, AZ jobs
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Summary: The SeniorProjectManager is responsible for end-to-end management of cross-functional teams coordinating all aspects of multi-departmental and/or multi-site projects. This includes planning, execution and finalizing projects per established scope, timeline and budget criteria. Working with project teams, the incumbent identifies and facilitates resolution of issues to minimize impact on project plans. The SeniorProjectManager is also responsible for planning and leading key strategic programs impacting the Phoenix Manufacturing organization. The SeniorProjectManager supports the development and continual improvement of project and program management competencies.
Responsibilities:
Employ strategic visioning and planning to align program goals and benefits with the goals of the organization.
Manage and lead cross-functional project and/or program teams • Ensure benefits, scope, goals and deliverables are well defined and understood by the team and stakeholders.
Lead team meetings and ensure that meeting agendas and minutes are issued in a timely manner.
Set and continually manage expectations with team members and other stakeholders. Where needed delegate tasks and responsibilities to appropriate personnel.
Develop full scale plans and timelines with input from all required departments.
Draft and submit budget proposals, and recommend subsequent budget changes where necessary •
Schedule, track milestones and deliverables using appropriate tools.
Identify and manage dependencies and critical path.
Anticipate challenges and risks. Prepare, lead and execute proactive mitigation strategies to ensure optimal results.
Proactively manage changes in scope, identify potential crises and devise contingency plans. Identify and resolve issues and conflicts with/within the team.
Establish and maintain transparency by supporting development, updates and maintenance of project, program and portfolio status reports, department performance reports and associated dashboards.
Ensure that communications between teams, functional management, seniormanagement and executive leadership are handled in an efficient, effective and timely fashion.
Conduct lessons learned evaluations with teams. Create recommendations and identify successful and unsuccessful project elements.
Ensure cGMPs are considered during project implementation. Apply knowledge of cGMPs to job responsibilities. Examples include but are not limited to:
Generation, review, approval of controlled documentation (e.g. SOPs, Work Practices, Change Controls) within global quality management systems. Identify Continuous Improvement Opportunities via exposure to projects, working knowledge of existing operations, or thru independent research.
Performs other tasks as assigned.
Qualifications:
Specific Knowledge, Skills, Abilities:
Advanced knowledge of both theoretical and practical aspects of projectmanagement combined with projectmanagement techniques and tools • Detailed knowledge and interpretation of cGMP
Intermediate understanding of site quality GxP systems supporting document management, change controls
Advanced written and verbal communication skills
Ability to work independently, lead and participate in a team
Advanced strategic thinking and team facilitation skills
Advanced critical reasoning, negotiation, problem solving, and decision-making skills
Strong organizational skills and ability to effectively manage assignments • Intermediate proficiency in Microsoft Word, Outlook, Excel, and PowerPoint, Visio, MS Project
Basic proficiency in SharePoint
Education/Experience/ Licenses/Certifications:
Bachelor's degree required, preferably in a related science or in Engineering • Advanced degree preferred
9 years' relevant work experience required, preferably in pharmaceutical development and/or manufacturing experience
5 years' management/projectmanagement responsibilities facilitating cross functional projects in a regulated industry preferred
Preferable experience includes laboratory testing, manufacturing or validation (e.g. equipment, process, computerized systems)
An equivalent combination of education, experience, certification (e.g. PMP) and training may substitute.
BMSCART
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Phoenix - AZ - US: $128,780 - $156,055
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
* Health Coverage: Medical, pharmacy, dental, and vision care.
* Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
* Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
* Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at *****************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1597724 : SeniorProjectManager
A global biopharmaceutical leader focused on developing innovative medicines for patients with serious diseases is seeking a SeniorManager, ProjectManagement. This organization has a diverse portfolio in neuroscience and oncology and a strong pipeline of cutting-edge therapies. In this role, you will lead and support FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs, ensuring compliance and operational excellence. Responsibilities include managing regulatory documentation and submissions, coordinating cross-functional and vendor meetings, overseeing stakeholder materials, and providing strategic updates to senior leadership.
Key Responsibilities
Execute and manage U.S. FDA-mandated REMS programs through effective projectmanagement.
Prepare and coordinate REMS regulatory documentation, ensuring timely submissions and responses to FDA requests.
Lead internal and external REMS meetings, manage timelines, and follow up on deliverables.
Oversee development and updates of REMS stakeholder materials.
Maintain submission archives and documentation repositories.
Support senior leadership with presentations and project updates.
Qualifications
Bachelor's degree in a relevant field required.
4-6 years in the pharmaceutical industry.
2-3 years of experience with REMS preferred.
Minimum 2 years in pharmaceutical projectmanagement.
Strong proficiency in Microsoft Office Suite and PowerPoint design.
Excellent communication, organizational skills, and attention to detail.
Ability to work independently in a remote environment.
Note: This role focuses on Regulatory ProjectManagement regarding REMS programs rather than Regulatory submissions.
$95k-130k yearly est. 3d ago
Import Sourcing and Project Manager
Linton Group 4.1
Pennsylvania jobs
Linton Group partners with leading brands to design, develop, source, manufacture, and deliver high-quality products at competitive costs. With a mission to empower brands to achieve their full potential, Linton provides tailored solutions for every client, focusing on innovation and manufacturing optimization. The company is committed to maintaining exceptional quality standards while reducing overall production expenses. Their team of experts brings in-depth knowledge and experience, building long-term partnerships based on trust and mutual success.
Role Description
This is a full-time, on-site role for an Import Sourcing and ProjectManager located in Bala-Cynwyd, PA. The individual will manage product sourcing and supplier relationships, oversee Purchase Order fulfillment and quality control activities, and lead various projects to ensure effective sourcing and manufacturing processes. Responsibilities include participating in new and existing product sourcing, identifying cost optimization opportunities, ensuring quality control standards, managing supply chain operations, and analyzing data to support decision-making. Collaboration with cross-functional teams and suppliers to deliver projects on time and within budget is a crucial part of the role.
Qualifications
3+ years experience in international sourcing and Purchase Order process
Proven track record in Supplier Management and Procurement processes
Strong Analytical Skills to evaluate cost efficiency and data effectively
Proficiency in Purchase Management and understanding of procurement workflows
Proven ability to execute ProjectManagement tasks, ensuring milestones and deadlines are met
Excellent communication, negotiation, and organizational skills in Mandarin and English (MUST HAVE)
Knowledge of import/export regulations and supply chain management
Bachelor's degree in Business Administration, Supply Chain Management, or a related field
Prior industry experience and proficiency with procurement software tools are preferred
What we offer
💲 SALARY: Competitive compensation package plus bonus
🌍 GLOBAL EXPOSURE: Work directly with international vendors, overseas teams, and global supply partners
☀️ PAID TIME OFF: Structured PTO policy supporting vacation and personal wellness
🩺 MEDICAL BENEFITS: 100% employee medical coverage; family group rates available
🧠 MENTORSHIP: Direct mentorship and hands-on training from the CEO
📅 WORK STYLE: 100% in-office at our Bala Cynwyd, PA headquarters
📍 OFFICE PERKS & LOCATION: Onsite fitness center (membership available for a fee), café, complementary parking, EV charging, and more - just 15-20 minutes from Center City Philadelphia with easy access from both the city and suburbs
💼 CAREER ADVANCEMENT: Opportunity to grow with the company as Linton continues to scale
About Linton Group
Linton Group is a rapidly growing small business based in Bala Cynwyd, Pennsylvania, providing high-quality sourcing, manufacturing, and supply chain management services across industries including Electronics, Pets, Toys & Games, Garden & Home Improvement, Apparel, Home, Kitchen & Dining, and Jewelry.
Our mission is to empower brands to reach their full potential by helping them optimize production, reduce costs, and maintain the highest standards of quality. We pride ourselves on being a trusted, consultative partner-delivering personalized service and innovative solutions tailored to each client's unique goals.
With just three years in business and continued rapid growth, Linton Group offers an entrepreneurial environment where high performers can make an immediate impact, work closely with leadership, and grow alongside the company.
The policy of Linton Group is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's race, color, gender, age, national origin, religion, citizenship status, marital status, sexual orientation, gender identity, transgender status, physical or mental disability, protected veteran status, genetic information, pregnancy, or any other categories protected by applicable federal, state or local laws. Linton Group is an Equal Opportunity Employer - Minority/Female/Disabled/Protected Veterans.
$80k-117k yearly est. 3d ago
Patient Support Business Systems Manager
Vertex Pharmaceuticals 4.6
Boston, MA jobs
The Patient Support Business Systems Manager supports the Kidney Patient Support team by managing the launch and continuous improvement of a new customer relationship management (CRM) system. This is an individual contributor role and a member of the US, Patient Support Center of Excellence (CoE).
The Patient Support Business Systems Manager partners deeply with Patient Support, Access & Reimbursement, Training, Quality & Compliance, Field teams, Data & Analytics, and Technology partners to translate business needs into scalable digital workflows, integrations, analytics, and enhancements that improve speed-to-therapy, patient experience, and operational efficiency. This role manages the CRM system and digital engagement tools that patient support specialists use in their day-to-day workflows to engage with patients and HCPs, specifically where processes overlap, and systems are integrated.
Key Duties and Responsibilities:
Collaborate with business stakeholders to gather and groom functional requirements, then communicate with technical teams to translate items into technical system requirements.
Strong background and working knowledge of AI-enabled patient service capabilities to improve access, speed to therapy, and patient/HCP engagement while meeting compliance and data governance standards
Build and maintain end to end process flows across patient access and engagement journeys; facilitate functional and technical workshops to document current/future state, surface inefficiencies, and convert opportunities into prioritized backlog items and measurable workflow optimizations.
Align and support creation of the annual business project plan and roadmap for Patient Services CRM with clear milestones and dependencies based on the overall vision. Ensure full alignment with Data, Technology and Engineering (DTE) function.
Facilitates capability prioritization discussions with PSP team and can speak to their perspective on business priorities.
Using strong projectmanagement, leadership, and communication skills hold self and PSP team accountable to stay on track with deliverable deadlines for requirements and annual planning.
Works closely with DTE ProjectManager to oversee end to end sprint management activities and ceremonies.
Managing the product backlog, proactively raising issues and constantly conducting prioritization exercises based on changing business requirements within Jira.
Participate in the RFP process for tools, technologies, and support with DTE.
Provides Implementation support including validation of business requirements and User Acceptance Testing (UAT).
Partner with Commercial Training and Change Management teams to ensure necessary supporting materials are provided and training content is consistent with system functionality.
Knowledge and Skills:
Experience in supporting commercial systems for patient support programs/hub services a plus
Demonstrated strong projectmanagement, troubleshooting, and problem-solving skills
Proven track record of success with strong results and excellent customer relationship skills
Expected to be knowledgeable of the CRM system and digital engagement tools with patients/HCPs, understanding where processes and systems overlap and integrate to help drive process efficiencies for patient support specialists
Excellent interpersonal, communication, organizational and facilitation skills
Proactive, Self-motivated, Independent worker
Passion for understanding emerging technologies with pragmatic insight into where those technologies can be integrated into business solutions
Able to perform in a fast-paced environment, manage multiple priorities simultaneously, and communicate complex information clearly
Education and Experience:
Bachelor's degree in computer science, software engineering or other related technology degree.
Salesforce certifications
5+ years' relevant experience in life sciences organization or healthcare industry, including experience working with Salesforce platform, Salesforce Life Sciences Cloud / Health Cloud or similar CRM
Pay Range:
$124,000 - $186,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
$124k-186k yearly Auto-Apply 14d ago
Project Program Manager
Advanced Rx Management 4.0
Fort Lauderdale, FL jobs
TheProject/Program Managerwill oversee complex projects and programs that span multiple departments within Advanced Rx, and may include collaboration with external vendors, suppliers, and customers. This individual will be responsible for the overall project lifecycle from planning and execution to delivery and reporting. The Project/Program Manager will create and maintain comprehensive project plans, coordinate activities across all involved teams, and ensure alignment with organizational goals. Regular updates and progress reports will be presented to the Leadership Team.
Key Responsibilities
Develop, implement, and manage detailed project and program plans, timelines, and deliverables.
Coordinate the successful launch of new accounts and major company initiatives.
Lead cross-functional project teams, ensuring clear communication and alignment across all departments.
Monitor and report on project progress, identifying and resolving issues or delays proactively.
Facilitate regular project meetings and provide weekly updates to the Leadership Team.
Ensure adherence to timelines, scope, and quality standards for all assigned projects.
Manage relationships with internal stakeholders and external partners, including vendors, suppliers, and customers.
Support data collection and analysis for strategic projects and potential investor initiatives.
Examples of Projects/Programs Managed:
Vertex Program
LMN Implementation for Dispensing & Pharmacy
Workers Compensation Pharmacy Transitions, including new Work Comp pharmacy build-out support
New Product and Program Launches
Terrain Product Utilization Initiatives
DoctorPatient Avatar Program
Repack Rebate Program
Potential Investor Data Gathering and Management
Key Qualifications
Bachelors degree in business administration, ProjectManagement, or related field (Masters degree or PMP certification preferred).
Minimum of 5 years of progressive projectmanagement experience, preferably in healthcare, pharmacy, or a related industry.
Proven ability to manage multiple, cross-functional projects simultaneously.
Strong organizational and time-management skills with a results-driven mindset.
Excellent written and verbal communication skills, with the ability to present clearly to executives and diverse teams.
Demonstrated ability to create and manage comprehensive project plans and tracking systems.
Strong negotiation, collaboration, and interpersonal skills.
Ability to quickly learn and understand complex project scopes.
Compensation and Benefits
Base Salary:$80,000 - $95,000/yr.
Bonus Potential:Up to 10%
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance
Education:
Bachelor's (Preferred)
Experience:
Projectmanagement: 4 years (Preferred)
Ability to Commute:
Sunrise, FL 33323 (Preferred)
Work Location: Hybrid remote in Sunrise, FL 33323
$80k-95k yearly 24d ago
Associate Director, Program / Project Manager
BD Systems 4.5
Salt Lake City, UT jobs
SummaryWe are a global business within BD Medical, dedicated to delivering quality and innovative solutions in Advanced Access Devices (AAD). The business is committed to maintaining its accelerated growth through portfolio diversification, differentiated offerings and geographic / market expansions, while maintaining the profitability of the core product lines. We manage a healthy portfolio of programs ranging from incremental innovation to disruptive & breakthrough opportunities enabling medication delivery solutions. Our projectmanagers have passion for bringing new technical solutions to market to meet serious unmet clinical needs, have strong records of professional achievement, and have the capacity and desire for continuous development and growth. We strive to provide each individual with opportunities to develop skills, gain and share knowledge, understand and deliver what our customers want and build a rewarding and fulfilling career.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities:
This high visibility position will be responsible for leading and motivating a large scale cross functional NPD team of high complexity within the AAD Platform within the Business Group of MDS.
Complete understanding of a wide application of projectmanagement principles, theories, and concepts. Including but not limited, customer scope requirements, work breakdown structures, risk management, integrated business plans, and product requirements.
Delivers projects on-time through predictable and transparent execution.
Serving as an agile problem solver, master negotiator, motivational coach, product development process expert, prudent risk taker, and team champion.
Influences solutions and works to resolve business and/or technical problems at all levels of the organization.
A strong, influential communicator who implements the strategic and technical direction for the project/program team.
Finds and creates new avenues of excellence. Self-starting and will take action without prompting or direction from others to solve problems.
Demonstrates a working knowledge of business, market growth drivers and trends, influences business case development.
Has a thorough understanding of all functional work streams in a phase gate process and a vision of an integrated project plan.
Collaborate with cross-functional teams to ensure timely delivery, review and approvals via multiple regional registrations in addition to other conflicting/dependent programs.
Responsible for the execution, quality, and results of the projects and the success of the resulting products for the business or in the market.
Interact with functional managers and business leaders to communicate critical project risks, mitigations, questions and/or challenges.
Define program resource needs and negotiate program resourcing plans. Work with functional leaders to ensure the appropriate core team resources are committed to the program and contribute to the required performance levels.
Mentor, coach and challenge core team members, functional leaders and business leaders regarding functional and cross functional strategies and approaches to improve program development outcomes.
Analyze development situations and data with in-depth evaluation of multiple factors.
Influence solutions to business or technical problems.
Communicate and implement the strategic and technical direction for the project/program teams.
Minimum Requirements:
BS degree in engineering (required)
At least 10 years relevant experience in medical device product development and design
3+ years of experience leading medical device cross-functional, global teams through complex projects or programs
New product development experience with Class II medical devices
Successful launch experience of medical device products from concept through launch
Ability to develop technical and business process solutions to complex problems
Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC)
Complete understanding of medical device projectmanagement principles, theories & concepts
Experience with creating work breakdown structures, risk management, and integrated business plans
Thorough understanding of functional work streams in a phase gate process
Experience in medical device product development planning, risk identification, and timeline optimization
Experience leading development of commercialization strategies
Excellent interpersonal, communication, presentation and influencing skills
Preferred Requirements:
Advanced degree in an engineering discipline or MBA
Six-sigma design and development background
PMP certification or equivalent
Additional Desired Skills/ Experience:
Self-starting attitude with ability to take initiative without direction
Experience representing an organization as prime contact on contracts and projects
Experience interacting with senior external personnel on technical matters
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
#CLOLI
Required Skills
Optional Skills
.
Primary Work LocationUSA UT - Salt Lake City BASAdditional LocationsUSA UT - SandyWork Shift
$79k-104k yearly est. Auto-Apply 22d ago
Associate Project Manager
Suvoda 4.1
Conshohocken, PA jobs
We are seeking an entry-level, analytically-oriented Associate ProjectManager to join our team! Our ideal candidate is someone who thrives in a fast-paced and dynamic environment, and takes initiative to seek out information, knowledge, and development, proactively. He or she is a resourceful problem solver who is savvy with technology and finds effective and efficient solutions to complex client problems. The Associate ProjectManager is a true self-starter who deals well with uncertainty and ambiguity. Lastly, he or she is a proven team player who puts the success of the team first.
Responsibilities include (but are not limited to):
* Work as part of a cross-functional project team responsible for the delivery of Interactive Response Technology (IRT) for randomization and drug supply management in clinical trials
* Support the Services Delivery project team in:
* Liaising with the client to discuss requirements, handle issues, provide status updates, and answer questions
* Designing the IRT solution to meet the study requirements based on the clinical protocol, Suvoda proposal and discussions with the client
* Accurately and completely documenting all requirements and participating in internal and external specification review meetings
* Assisting with client review meetings of IRT specifications and supporting documents, making any required updates
* Managingproject schedules and scope, tracking all internal and client tasks required to meet project milestones
* Managing the cross-functional project team's schedule and task assignments
* Assisting with creating the UAT plan, developing test scripts, coordinating data setup, and providing client support for client UAT
* Providing protocol-specific support to the client and support team after go-live
* Ensure client satisfaction throughout the project build and maintenance phase, working with Suvoda management, the Suvoda product team, and business development as needed
* Provide system training to end-users using in-person meetings, web meetings, and user manuals
* Provide telephone and email support to system users globally
* Travel to client sites to attend meetings and conduct user training sessions
* Perform other related duties as required
Requirements:
* Bachelor's degree (in life sciences or computer science preferred)
* Interpersonal and communication skills
* Time management and organizational skills
* Analytical thinking ability
* Creative problem-solving ability
* Attention to detail
Special Note: Applicants must be currently authorized to work in the United States on a full-time basis.
#LI-AC1
We are aware that an individual(s) are fraudulently representing themselves as Suvoda recruiters and/or hiring managers. Suvoda will never request personal information such as your bank account number, credit card number, drivers license or social security number - or request payment from you - during the job application or interview process. Any emails from the Suvoda recruiting team will come from ************* email address. You can learn more about these types of fraud by referring to this FTC consumer alert.
As set forth in Suvoda's Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you are based in California, we encourage you to read this important information for California residents linked here.
$139k-259k yearly est. Auto-Apply 44d ago
Project Program Manager
Advanced Rx Management 4.0
Sunrise, FL jobs
The Project/Program Manager will oversee complex projects and programs that span multiple departments within Advanced Rx, and may include collaboration with external vendors, suppliers, and customers. This individual will be responsible for the overall project lifecycle - from planning and execution to delivery and reporting. The Project/Program Manager will create and maintain comprehensive project plans, coordinate activities across all involved teams, and ensure alignment with organizational goals. Regular updates and progress reports will be presented to the Leadership Team.
Key Responsibilities
Develop, implement, and manage detailed project and program plans, timelines, and deliverables.
Coordinate the successful launch of new accounts and major company initiatives.
Lead cross-functional project teams, ensuring clear communication and alignment across all departments.
Monitor and report on project progress, identifying and resolving issues or delays proactively.
Facilitate regular project meetings and provide weekly updates to the Leadership Team.
Ensure adherence to timelines, scope, and quality standards for all assigned projects.
Manage relationships with internal stakeholders and external partners, including vendors, suppliers, and customers.
Support data collection and analysis for strategic projects and potential investor initiatives.
Examples of Projects/Programs Managed:
Vertex Program
LMN Implementation for Dispensing & Pharmacy
Workers' Compensation Pharmacy Transitions, including new Work Comp pharmacy build-out support
New Product and Program Launches
Terrain Product Utilization Initiatives
Doctor-Patient Avatar Program
Repack Rebate Program
Potential Investor Data Gathering and Management
Key Qualifications
Bachelor's degree in business administration, ProjectManagement, or related field (Master's degree or PMP certification preferred).
Minimum of 5 years of progressive projectmanagement experience, preferably in healthcare, pharmacy, or a related industry.
Proven ability to manage multiple, cross-functional projects simultaneously.
Strong organizational and time-management skills with a results-driven mindset.
Excellent written and verbal communication skills, with the ability to present clearly to executives and diverse teams.
Demonstrated ability to create and manage comprehensive project plans and tracking systems.
Strong negotiation, collaboration, and interpersonal skills.
Ability to quickly learn and understand complex project scopes.
Compensation and Benefits
Base Salary: $80,000 - $95,000/yr.
Bonus Potential: Up to 10%
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance
Education:
Bachelor's (Preferred)
Experience:
Projectmanagement: 4 years (Preferred)
Ability to Commute:
Sunrise, FL 33323 (Preferred)
Work Location: Hybrid remote in Sunrise, FL 33323
$80k-95k yearly 60d+ ago
CQV Project/Program Manager
Pharmatek Consulting 4.0
Mount Vernon, IN jobs
KEY RESPONSIBILITIES
Capital ProjectManagement: Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals.
Technical Leadership: Oversee engineering activities for projects including, but not limited to: Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
Budget & Financial Oversight: Develop and maintain accurate project budgets and forecasts; monitor project spend, track variances, and ensure financial accountability for capital expenditures.
Documentation & Phase Deliverables: Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects.
Cross -Functional Collaboration: Partner with Manufacturing, Quality, Validation, and other cross -functional stakeholders to deliver integrated project outcomes and support site readiness for commercial and clinical operations.
Vendor & Contractor Management: Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements
Requirements
Experience:
Minimum 7-10 years of experience in pharmaceutical manufacturing with a focus on Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
Proven track record in capital projectmanagement, managing multiple projects at once.
Technical Expertise:
Strong understanding of Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
Knowledge of pharmaceutical packaging, modern controls and safety devices, tablet inspection systems, SCADA/PAS -X integrations, and equipment validation.
Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ).
Project & Financial Skills:
Highly skilled utilizing Microsoft Project for schedule/project plan development.
Skilled in budgeting, forecasting, and cost control within complex, regulated environments.
Soft Skills:
Strong leadership and communication skills, with the ability to influence cross -functional teams.
Highly organized, detail -oriented, and capable of managing multiple priorities in a dynamic environment.
Other:
Willingness to work onsite at a GMP manufacturing facility
Education:
Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.
$72k-97k yearly est. 42d ago
Associate Project Manager
Frontage Laboratories 3.9
Exton, PA jobs
Job Description
Associate ProjectManager- Bioanalytical & Biologics Services
Reports to: Group Leader, BioA ProjectManagement
Full-time
Frontage Laboratories:
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Bioanalytical & Biologics Services:
At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays
Position Summary:
-Manage and monitor project progress and timelines to ensure successful completion from start up to end of study.
-Participate and communicate effectively in project meetings with clients on a regular basis as well as with cross-functional teams to ensure projects are met with quality and within the applicable scope and budget.
-Collaborate with the financial sector throughout various stages of projects (monthly invoices, revenue recognition, and budget final reconciliation).
-Support Management and BD team for new business opportunities.
-Onsite is required as needed.
Position Responsibilities:
-Minimizes risks on projects by working closely with the lab operations and lab support teams, PIs, and sponsors to ensure project progress is met for each milestone in accordance with project scope per requested timelines by the sponsor.
-Creates, updates and tracks projects in projectmanagement tool (QuickBase) daily and generating project trackers and reports as requested.
-Leads/participate in project meetings with sponsors on a regular basis or on as needed basis and prepare meeting minutes to ensure alignment of deliverables.
-Serves as a liaison between internal departments (scientific staff, QC/TW, QA, SM, etc.) to ensure project timelines are met with quality.
-Proactively communicate with clients on project timelines, issues, and updates via phone, e-mails, or TC as necessary.
-Requests and reviews invoices per milestone on a rolling basis that are tracked in QuickBase and respond to client's questions related to invoices or finance aspects or assists finance team on those issues as needed (i.e. revenue recognition per month and final budget reconciliation.
-Facilitate internal and external communication and activities on data transfer specification (DTS) development and complete data transfers to data management vendors/sponsors.
-Participate in onsite client visits and assist internally in preparation as necessary.
Position Requirements:
Bachelor's degree or higher in biological sciences, chemistry, or related discipline.
In-depth knowledge of bioanalytical and/or biologics assays.
Minimum 1-2 years of projectmanagement experience in GLP, Pharmaceutical or CRO environment.
Excellent communication and strong client relationship management skills.
Proficient with Excel, Word, PowerPoint and other computer skills.
Good Time Management/ Organizational skills adopting a committed approach to providing a high level of customer service when managing multiple tasks.
Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients.
Salary and Benefits:
Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$132k-238k yearly est. 23d ago
Associate Project Manager
Frontage Lab 3.9
Exton, PA jobs
Associate ProjectManager- Bioanalytical & Biologics Services Reports to: Group Leader, BioA ProjectManagement Full-time Frontage Laboratories: Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Bioanalytical & Biologics Services:
At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays
Position Summary:
* Manage and monitor project progress and timelines to ensure successful completion from start up to end of study.
* Participate and communicate effectively in project meetings with clients on a regular basis as well as with cross-functional teams to ensure projects are met with quality and within the applicable scope and budget.
* Collaborate with the financial sector throughout various stages of projects (monthly invoices, revenue recognition, and budget final reconciliation).
* Support Management and BD team for new business opportunities.
* Onsite is required as needed.
Position Responsibilities:
* Minimizes risks on projects by working closely with the lab operations and lab support teams, PIs, and sponsors to ensure project progress is met for each milestone in accordance with project scope per requested timelines by the sponsor.
* Creates, updates and tracks projects in projectmanagement tool (QuickBase) daily and generating project trackers and reports as requested.
* Leads/participate in project meetings with sponsors on a regular basis or on as needed basis and prepare meeting minutes to ensure alignment of deliverables.
* Serves as a liaison between internal departments (scientific staff, QC/TW, QA, SM, etc.) to ensure project timelines are met with quality.
* Proactively communicate with clients on project timelines, issues, and updates via phone, e-mails, or TC as necessary.
* Requests and reviews invoices per milestone on a rolling basis that are tracked in QuickBase and respond to client's questions related to invoices or finance aspects or assists finance team on those issues as needed (i.e. revenue recognition per month and final budget reconciliation.
* Facilitate internal and external communication and activities on data transfer specification (DTS) development and complete data transfers to data management vendors/sponsors.
* Participate in onsite client visits and assist internally in preparation as necessary.
Position Requirements:
* Bachelor's degree or higher in biological sciences, chemistry, or related discipline.
* In-depth knowledge of bioanalytical and/or biologics assays.
* Minimum 1-2 years of projectmanagement experience in GLP, Pharmaceutical or CRO environment.
* Excellent communication and strong client relationship management skills.
* Proficient with Excel, Word, PowerPoint and other computer skills.
* Good Time Management/ Organizational skills adopting a committed approach to providing a high level of customer service when managing multiple tasks.
* Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients.
Salary and Benefits:
Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$132k-238k yearly est. 60d+ ago
Associate Project Manager
Frontage Laboratories 3.9
Exton, PA jobs
Associate ProjectManager- Bioanalytical & Biologics Services
Reports to: Group Leader, BioA ProjectManagement
Full-time
Frontage Laboratories:
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Bioanalytical & Biologics Services:
At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays
Position Summary:
-Manage and monitor project progress and timelines to ensure successful completion from start up to end of study.
-Participate and communicate effectively in project meetings with clients on a regular basis as well as with cross-functional teams to ensure projects are met with quality and within the applicable scope and budget.
-Collaborate with the financial sector throughout various stages of projects (monthly invoices, revenue recognition, and budget final reconciliation).
-Support Management and BD team for new business opportunities.
-Onsite is required as needed.
Position Responsibilities:
-Minimizes risks on projects by working closely with the lab operations and lab support teams, PIs, and sponsors to ensure project progress is met for each milestone in accordance with project scope per requested timelines by the sponsor.
-Creates, updates and tracks projects in projectmanagement tool (QuickBase) daily and generating project trackers and reports as requested.
-Leads/participate in project meetings with sponsors on a regular basis or on as needed basis and prepare meeting minutes to ensure alignment of deliverables.
-Serves as a liaison between internal departments (scientific staff, QC/TW, QA, SM, etc.) to ensure project timelines are met with quality.
-Proactively communicate with clients on project timelines, issues, and updates via phone, e-mails, or TC as necessary.
-Requests and reviews invoices per milestone on a rolling basis that are tracked in QuickBase and respond to client's questions related to invoices or finance aspects or assists finance team on those issues as needed (i.e. revenue recognition per month and final budget reconciliation.
-Facilitate internal and external communication and activities on data transfer specification (DTS) development and complete data transfers to data management vendors/sponsors.
-Participate in onsite client visits and assist internally in preparation as necessary.
Position Requirements:
Bachelor's degree or higher in biological sciences, chemistry, or related discipline.
In-depth knowledge of bioanalytical and/or biologics assays.
Minimum 1-2 years of projectmanagement experience in GLP, Pharmaceutical or CRO environment.
Excellent communication and strong client relationship management skills.
Proficient with Excel, Word, PowerPoint and other computer skills.
Good Time Management/ Organizational skills adopting a committed approach to providing a high level of customer service when managing multiple tasks.
Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients.
Salary and Benefits:
Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Lancaster, PA, USA Full-time ** **About Us** **Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.** **Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.**
**In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.**
**In 2019, Eurofins generated** **total revenues of EUR 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.**
**Job Description**
**Role Overview**
The GMP Testing ProjectManager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients.
**Key Responsibilities**
+ **ProjectManagement**
+ Lead and manage multiple GMP testing projects from initiation to closure.
+ Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery.
+ Monitor progress, identify risks, and implement mitigation strategies.
+ Ensure all deliverables meet client expectations and regulatory requirements.
+ Prepare and present project updates and reports to internal and external stakeholders.
+ Track, manage and report turnaround time metrics and schedule variance.
+ **Client Communication**
+ Serve as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams.
+ Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings.
+ Prepare and present project status and performance KPIs in client Business Review Meetings.
+ **Financial Management**
+ Work closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and value
+ Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow.
+ **Compliance & Quality**
+ Ensure testing activities comply with GMP, GLP, and relevant regulatory guidelines.
+ Maintain accurate documentation in accordance with Quality Management Systems (QMS).
+ Support audits and inspections by regulatory authorities and clients.
+ Drive investigations to timely closure.
+ **Team Collaboration**
+ Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development).
+ Collaborate with partner Eurofins sites and subcontractors as required.
**Qualifications**
Qualifications
**Education:**
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
+ **Experience:**
+ Strong background in pharmaceutical sciences, analytical chemistry, or biologics.
+ Experience in GMP lab operations, especially in CMC testing.
+ Proven ability to manage complex projects and cross-functional teams.
+ Familiarity with regulatory requirements and quality standards.
+ Excellent communication and client management skills.
+ **Skills:**
+ Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP).
+ Excellent organizational and time-management skills.
+ Proficiency in projectmanagement tools (MS Project, Smartsheet).
+ Strong communication and stakeholder management abilities.
+ Authorization to work in the United States indefinitely without restriction or sponsorship
**Additional Information**
**Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m Hours are flexible.** Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
**We offer excellent full-time benefits including** :
+ comprehensive medical coverage,
+ life and disability insurance,
+ 401(k) with company match,
+ paid holidays and vacation,
+ dental and vision options.
**Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.**
About Us
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Role Overview
The GMP Testing ProjectManager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients.
Key Responsibilities
ProjectManagement
Lead and manage multiple GMP testing projects from initiation to closure.
Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery.
Monitor progress, identify risks, and implement mitigation strategies.
Ensure all deliverables meet client expectations and regulatory requirements.
Prepare and present project updates and reports to internal and external stakeholders.
Track, manage and report turnaround time metrics and schedule variance.
Client Communication
Serve as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams.
Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings.
Prepare and present project status and performance KPIs in client Business Review Meetings.
Financial Management
Work closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and value
Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow.
Compliance & Quality
Ensure testing activities comply with GMP, GLP, and relevant regulatory guidelines.
Maintain accurate documentation in accordance with Quality Management Systems (QMS).
Support audits and inspections by regulatory authorities and clients.
Drive investigations to timely closure.
Team Collaboration
Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development).
Collaborate with partner Eurofins sites and subcontractors as required.
Qualifications
Qualifications
Education:
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
Experience:
Strong background in pharmaceutical sciences, analytical chemistry, or biologics.
Experience in GMP lab operations, especially in CMC testing.
Proven ability to manage complex projects and cross-functional teams.
Familiarity with regulatory requirements and quality standards.
Excellent communication and client management skills.
Skills:
Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP).
Excellent organizational and time-management skills.
Proficiency in projectmanagement tools (MS Project, Smartsheet).
Strong communication and stakeholder management abilities.
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m Hours are flexible. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
We offer excellent full-time benefits including:
comprehensive medical coverage,
life and disability insurance,
401(k) with company match,
paid holidays and vacation,
dental and vision options.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
About Us
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Role Overview
The GMP Testing ProjectManager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients.
Key Responsibilities
ProjectManagement
Lead and manage multiple GMP testing projects from initiation to closure.
Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery.
Monitor progress, identify risks, and implement mitigation strategies.
Ensure all deliverables meet client expectations and regulatory requirements.
Prepare and present project updates and reports to internal and external stakeholders.
Track, manage and report turnaround time metrics and schedule variance.
Client Communication
Serve as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams.
Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings.
Prepare and present project status and performance KPIs in client Business Review Meetings.
Financial Management
Work closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and value
Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow.
Compliance & Quality
Ensure testing activities comply with GMP, GLP, and relevant regulatory guidelines.
Maintain accurate documentation in accordance with Quality Management Systems (QMS).
Support audits and inspections by regulatory authorities and clients.
Drive investigations to timely closure.
Team Collaboration
Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development).
Collaborate with partner Eurofins sites and subcontractors as required.
Qualifications
Qualifications
Education:
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
Experience:
Strong background in pharmaceutical sciences, analytical chemistry, or biologics.
Experience in GMP lab operations, especially in CMC testing.
Proven ability to manage complex projects and cross-functional teams.
Familiarity with regulatory requirements and quality standards.
Excellent communication and client management skills.
Skills:
Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP).
Excellent organizational and time-management skills.
Proficiency in projectmanagement tools (MS Project, Smartsheet).
Strong communication and stakeholder management abilities.
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m Hours are flexible. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
We offer excellent full-time benefits including:
comprehensive medical coverage,
life and disability insurance,
401(k) with company match,
paid holidays and vacation,
dental and vision options.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
About Us Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Role Overview
The GMP Testing ProjectManager is responsible for planning, coordinating, and overseeing Good Manufacturing Practice (GMP)-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams and external clients.
Key Responsibilities
* ProjectManagement
* Lead and manage multiple GMP testing projects from initiation to closure.
* Establish and maintain comprehensive tracking tools for projects, including schedules, action trackers and dashboards to enforce accountability and timely delivery.
* Monitor progress, identify risks, and implement mitigation strategies.
* Ensure all deliverables meet client expectations and regulatory requirements.
* Prepare and present project updates and reports to internal and external stakeholders.
* Track, manage and report turnaround time metrics and schedule variance.
* Client Communication
* Serve as the primary point of contact for clients, ensuring clear communication and accurate interpretation of technical data across functional teams.
* Organize and facilitate planned and ad hoc project meetings including: project kick off, recurring project status calls, client technical visits, and project closure meetings.
* Prepare and present project status and performance KPIs in client Business Review Meetings.
* Financial Management
* Work closely with the Business Development team to grow client relationship and revenue through cross selling and managing assigned projects to provide exemplary customer experience and value
* Track financial performance - including FTE utilization, planned vs actual hours, budget variance, and cash flow.
* Compliance & Quality
* Ensure testing activities comply with GMP, GLP, and relevant regulatory guidelines.
* Maintain accurate documentation in accordance with Quality Management Systems (QMS).
* Support audits and inspections by regulatory authorities and clients.
* Drive investigations to timely closure.
* Team Collaboration
* Collaborate with cross-functional teams (Operations, QA, Sample Registration, Pricing, Business Development).
* Collaborate with partner Eurofins sites and subcontractors as required.
Qualifications
Qualifications
Education:
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
* Experience:
* Strong background in pharmaceutical sciences, analytical chemistry, or biologics.
* Experience in GMP lab operations, especially in CMC testing.
* Proven ability to manage complex projects and cross-functional teams.
* Familiarity with regulatory requirements and quality standards.
* Excellent communication and client management skills.
* Skills:
* Knowledge of GMP regulations (21 CFR Part 210/211, EU GMP).
* Excellent organizational and time-management skills.
* Proficiency in projectmanagement tools (MS Project, Smartsheet).
* Strong communication and stakeholder management abilities.
* Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday-Friday, 8:00 a.m.-4:00 p.m Hours are flexible. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
We offer excellent full-time benefits including:
* comprehensive medical coverage,
* life and disability insurance,
* 401(k) with company match,
* paid holidays and vacation,
* dental and vision options.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
$125k-231k yearly est. 9d ago
Temp, Associate Biospecimen Project Manager
Labconnect 4.2
Johnson City, TN jobs
The Temp, Associate Biospecimen ProjectManager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies Responsibilities: Drive biospecimen lifecycle management from sample receipt to analysis and final disposition
Ensure accurate specimen metadata
Communicate study specimen updates to client groups and stakeholders
Increase the efficiency of specimen management through sharing of knowledge and best practices
Provide site support and drive query resolution
Participate or lead special projects as assigned
Adhere to client policies and Standard Operating Procedures
Review clinical study protocols and service providers' scope of work documents for sample handling and processing details
Set up study and electronic protocol in LIMS.
Create and manageproject plans
Manage data transfer plans with analytical laboratories
Manage data received from external and internal laboratories, including data generated in exploratory studies
Manage specimen metadata discrepancies and ensure resolution
Submit specimens for analytical assays per study timelines
Review status of specimens received and completeness of data
Contribute to meeting database locks by ensuring all specimens have a final result and data transfer is complete; create reports for data management as needed
Support manager in providing projections for annual and long-term planning
Experience / Education:
Experience with StarLIMS or other LIMS desired
Understanding of transaction-based inventory and data management systems as well as clinical trial processes
Understanding of ICH, GCP, GLP, and local regulations
Excel experience, macro and template building knowledge desired
Strong planning, organizational, time management skills
B.A./B.S. in life sciences, medical technology, or related field and 1-3 years of directly related experience. Experience in life sciences or medically related fields, including clinical development, biospecimen lifecycle management, or clinical laboratory analysis. ProjectManagement experience is also preferred. Very high attention to detail and excellent multi-tasking skills is required for success in this position.
$118k-212k yearly est. 21d ago
Learn more about Takeda Pharmaceuticals U.S.A., Inc. jobs