Senior Director, Project Mgt Office
King of Prussia, PA jobs
Lead the Project Management Office for R&D
Main Responsibilities & Accountabilities
••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues.
Qualifications & Experience
Requirements
•12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
Auto-ApplyTechnical Project Manager
Charles City, IA jobs
The successful candidate will effectively manage and coordinate Biological Manufacturing technical projects and initiatives within Zoetis biologics manufacturing facilities. The scope of the support will include technical investigations, Cost Improvement Projects (CIPs), VMRD product transfers/launches, as well as internal GMS transfers across the network. The position requires strong leadership and demonstrates communication skills to collaborate across organizational lines (OpEx, Quality, Regulatory, EHS, Validation, Supply Chain, and Operations) to ensure timely resolution of major investigations and process flow improvements. The ideal candidate would have a strong biological background in analytical methods, process development, commercialization, and process capability. The candidate will be required to understand key technical data from the GMT bench scientists to represent the site on VMRD-led Co-development teams, raw material assessments, and technical transfers. The candidate will work with US, International and EU Regulatory, sites, and center groups to develop and execute strategies for filing, defending, and launching new products.
Position Responsibilities
Deliver allocated projects on budget and time to meet business objectives.
Make decisions that impact their own work and exercise judgment to complete assigned tasks.
Lead complex scientific teams to support site investigations, bad actors, and CIP initiatives as their primary role.
Manage the following team dynamics:
Accountability
Leadership with influence
Consensus building Definition of team roles and responsibilities
Facilitate recommendations of technical team to management
Deliver projects on time and budget
Organizational Relationships
The candidate will interact primarily with colleagues in GMT and Biological Product Manufacturing at either the Lincoln or Charles City sites. The candidate will also interact with VMRD as part of new-Product transfer teams as deemed appropriate.
Education and Experience
BA/BS with 9-13 years of experience OR MBA/MS with 7-11 years of experience within multiple departments at the site.
Bachelor's degree in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or related technical field.
Laboratory and/or manufacturing experience in biological manufacturing and/or testing is desirable, as well as knowledge of biological product formulation, emulsions, lyophilization, viral/bacterial antigen production systems and/or testing for veterinary biologics manufacturing. A working knowledge of vaccine production methods and experimental design and experience in cGLP or cGMP is also desirable.
High degree of personal motivation and attention to detail.
Strong oral and written communication, excellent interpersonal skills.
Strong commitment to safety, product quality, and working knowledge of RFT (Right First Time) principles.
Continuous improvement mindset using lean six sigma principles.
Familiarity with working with 9 CFR regulations
Working knowledge in process capability assessment and continuous process verification is preferred.
Physical Position Requirements
Typical office based working conditions of sitting at the computer and teleconferencing.
Some travel may be required as part of project transfers.
Occasional weekend work may be required.
Must be able to walk, sit, and stand for long periods of time.
Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip.
Must be able to lift and carry 5 to 25 lbs.
Project Manager (Utilities Construction)
Somerset, NJ jobs
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager to join our talented team at our office located in Somerset, New Jersey.
In this role, you will manage project coordination with Inside Plant (“IP”) Construction and Outage Planning, the engagement of various internal departments in the project, and communicate directly to ensure that project support needs are met by internal departments. You will also manage Project Engineering in the development of the Material Tracking Log (“MTL”), support all material procurement activities, and ensure that the MTL is maintained throughout the Project lifecycle.
Additional Responsibilities
Organizes weekly engineering meetings between Project Management, Project Engineering, Project Controls, Procurement, Licensing and Permitting, Corporate Properties, and the Architectural Engineering (“A&E”) firms.
Ensures the creation and distribution of weekly action item lists to project stakeholders.
Coordinates daily communication between the Project management team, Project Engineering, and the A&E firms.
Creation and management of the Project Scope Document, and participation in the procurement of all stakeholder signatures.
Creation and management of the Project Execution Plan and Risk Register, and participation in the stakeholder approval process.
Review Contractor submittals, including monthly reports, schedules, and cash flow documents.
Manage the following:
facilitation of design reviews by the Project Engineering Division, and ensuring that everything is signed by the appropriate parties
the development of monthly reports for the project and engaging all stakeholders in contributing to their individual sections
the facilitation of project detailed design by the A&E firm, and support the preparation, development, and review of technical specifications
the execution of the Quality Assurance and Control Plan
Project closeout activities, including lessons learned meetings, the submittal of As-Built drawings, documentation turnover, and the closeout of all permits and purchase orders.
Support site construction management in verifying that construction activities comply with design and specifications, and support the execution of the detailed commissioning and testing plan.
Support the documentation of all lessons learned activities in the Company database.
The salary range for this role is between $120,000 and $150,000 but actual salary offered is dependent on experience, skill set and education.
Qualifications & Requirements
15+ years of professional experience.
Bachelor's degree in a technical field: engineering, project management, construction management.
Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, EIT).
PMP Certification.
High level of computer expertise in multiple industry-wide software products, such as:
MS Office Products
Scheduling software such as Primavera and MS Project
Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR
PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems
Context, Environment, & Safety
A safety-minded individual who complies with the IPS Mission Zero Safety policy.
Capable of working alone or as part of a team without a significant level of supervision.
The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use.
Experience working in both a Home Office and a Field environment.
Travel to client sites as needed.
This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Project Manager - Rare Disease
San Diego, CA jobs
Clinical Project Manager - Rare Disease
San Diego, CA - On- Site
$115,000 - $140,000
A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research, regulatory coordination, and cross-functional leadership.
Key Responsibilities
Clinical Trial Oversight: Lead the planning, execution, and closeout of global clinical studies, ensuring alignment with development and regulatory goals.
Protocol & Site Management: Contribute to protocol design, site selection, and ongoing site relationships.
Regulatory Support: Assist in the preparation of regulatory documents (e.g., INDs, briefing books, investigator brochures) and support health authority interactions.
Cross-Functional Collaboration: Partner with internal teams across clinical operations, data management, medical affairs, and external vendors.
Scientific Contribution: Review clinical data, support interpretation of results, and contribute to publications and presentations.
Process Optimization: Participate in internal process improvement initiatives and mentor junior team members.
Budget & Vendor Management: Develop and manage clinical trial budgets and oversee CROs and other external partners.
Qualifications
Advanced degree in life sciences (PharmD, PhD or MS required).
5-7 years of clinical experience in biotech or pharmaceutical settings.
Proven track record in IND submissions and regulatory interactions.
Experience in rare diseases, metabolic, CNS, or liver/kidney indications preferred.
Familiarity with RNA-based platforms (si RNA, ASO) is a plus.
Strong project management, communication, and leadership skills.
Ability to work across time zones and manage international teams
This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
Project Manager
Saint Charles, IL jobs
Entry-Level Project Manager, Telecom & Datacenter Installations
Contel Inc. is seeking a highly motivated and organized Entry-Level Project Manager to contribute to the successful execution of telecommunications and datacenter infrastructure projects. This role is ideal for an individual with a strong desire to learn and grow within the project management field, supporting experienced Project Managers in delivering projects on time, within budget, and to the highest quality standards. This position requires strong communication skills and the ability to coordinate across various teams and stakeholders.
Key Responsibilities:
Assist Project Managers in the planning and execution phases of projects, including developing project plans, schedules, and budgets.
Coordinate internal resources and manage subcontractor relationships to ensure efficient project execution.
Track project progress, monitor milestones, and ensure adherence to project timelines and deliverables.
Assist in identifying and managing project risks and issues, escalating to senior management when necessary.
Facilitate project team meetings, prepare agendas, and document minutes to ensure effective communication and collaboration.
Ensure project documentation, including scope, requirements, and change orders, is created and maintained accurately.
Help prepare and present project status reports to clients and internal stakeholders.
Learn and apply project management methodologies and best practices under the guidance of senior Project Managers.
Required Skills and Qualifications:
Bachelor's degree in a relevant field such as Business, Engineering (Electrical, Civil, or Telecommunications preferred), IT, or a related field.
Strong organizational and time management skills with a proven ability to manage multiple priorities.
Excellent written and verbal communication and interpersonal skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Basic understanding of project management principles and methodologies.
Problem-solving mindset and adaptability to address challenges and changes throughout the project lifecycle.
Ability to work effectively both independently and as part of a team.
Preferred Skills:
Familiarity with project management software tools (e.g., MS Project, Asana, Jira).
Coursework or experience in telecommunications or datacenter environments is a plus.
Relevant certifications like Certified Associate in Project Management (CAPM) are beneficial.
Project Manager (DeltaV & OSIsoftPi)
Cambridge, MA jobs
Job Title: Project Manager - Life Sciences
Employment Type: Full-Time
About the Role:
We are seeking an experienced Project Manager to lead and deliver complex projects within the life sciences sector. This role requires strong technical expertise and hands-on experience with DeltaV and OSIsoft PI systems, ensuring successful implementation and integration across manufacturing and automation environments.
Key Responsibilities
Manage end-to-end project lifecycle for automation and process control initiatives in life sciences.
Coordinate cross-functional teams including engineering, validation, and operations.
Develop and maintain project plans, timelines, budgets, and resource allocation.
Ensure compliance with regulatory standards (GMP, FDA, etc.).
Oversee implementation and optimization of DeltaV distributed control systems.
Manage data integration and analytics using OSIsoft PI for process monitoring and reporting.
Identify risks, develop mitigation strategies, and ensure timely project delivery.
Communicate project status and updates to stakeholders and leadership.
Required Qualifications
Bachelor's degree in Engineering, Life Sciences, or related field.
5+ years of project management experience in life sciences or pharmaceutical manufacturing.
Proven experience with DeltaV automation systems and OSIsoft PI data historian.
Strong understanding of process control, automation, and data analytics.
Excellent leadership, communication, and stakeholder management skills.
Familiarity with GMP and regulatory compliance requirements.
Preferred Qualifications
PMP or equivalent project management certification.
Experience with large-scale automation projects in biotech or pharmaceutical environments.
Knowledge of validation processes and documentation standards.
Why Join Us?
Work on cutting-edge projects in a world-class life sciences hub.
Collaborative team environment with opportunities for growth.
Competitive compensation and benefits package.
Project Program Manager
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, Project Management, or related field (Masters degree or PMP certification preferred).
Minimum of 5 years of progressive project management 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:
Project management: 4 years (Preferred)
Ability to Commute:
Sunrise, FL 33323 (Preferred)
Work Location: Hybrid remote in Sunrise, FL 33323
Associate Project Manager
Conshohocken, PA jobs
We are seeking an entry-level, analytically-oriented Associate Project Manager 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 Project Manager 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
* Managing project 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.
Auto-ApplyAssociate Project Manager
Exton, PA jobs
Associate Project Manager- Bioanalytical & Biologics Services
Reports to: Group Leader, BioA Project Management
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 project management 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 project management 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.
Auto-ApplyAssociate Project Manager
Exton, PA jobs
Job Description
Associate Project Manager- Bioanalytical & Biologics Services
Reports to: Group Leader, BioA Project Management
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 project management 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 project management 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.
Associate Project Manager
Exton, PA jobs
Associate Project Manager- Bioanalytical & Biologics Services Reports to: Group Leader, BioA Project Management 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 project management 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 project management 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.
Associate Project Manager
Portland, OR jobs
We are seeking an entry-level, analytically-oriented Associate Project Manager 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 Project Manager 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
* Managing project 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.
Auto-ApplyAssociate Project Manager
New York, NY jobs
at Havas Health & You
.
Auto-ApplyAssociate Project Manager: Biopharmaceutical Product Testing
Lancaster, PA jobs
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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 50 countries. 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.
Job Description
Role Overview
The GMP Testing Project Manager 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
Project Management
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
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 project management 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. with additional hours, as needed. 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.
Construction Associate Project Manager
Lancaster, PA jobs
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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
Applies the highest quality standard in all areas of responsibility
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Technical understanding of building construction and engineering
Demonstrated experience with full-project life cycle from bidding through completion
Diagnose problems and propose solutions
Manage staff and outside contractors
Abiltiy to read, understand, and execute construction specifications and plans
Manage construction budgets
Manage multiple projects concurrently
Communicates effectively with internal and external contacts
Assist in managing subcontractors
Review construction drawings for accuracy
Represent owner in project meetings
Review pay applications
Participate in continuing education (Conferences, ABC classes, internal trainings)
Assist in designing new or renovated building spaces
Participate in Real Estate due diligence
Assist or manage purchasing of equipment or fixtures
Travel as needed to support remote sites
Support Senior / Principal PM or equivalent with project management
Assist lead PM with activity schedule preparation
Manage single- and multi-prime contractor projects with support from more experienced PM/leadership
Assist with preparation of bid documents
Assist with review of bids
Prepare site communications to impacted entities / people
Communicates effectively with client staff members
Conducts all activities in a safe and efficient manner
Performs other duties as assigned
Qualifications
High school diploma or equivalent;Technical degree in a trade discipline like engineering, fabrication, sheet metal design, etc is preferred
Minimum 2 years of previous construction experience required
Experience with building design, previous laboratory work experience
Experience using Procore Construction Management platform preferred
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to Lancaster, PA are encouraged to apply.
Excellent full-time benefits including:
Comprehensive medical coverage, dental, and vision options.
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Associate Project Manager: Biopharmaceutical Product Testing - Onsite
Lancaster, PA jobs
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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 50 countries. 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.
Job Description
Role Overview
The GMP Testing Project Manager 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
Project Management
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
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 project management 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. with additional hours, as needed. 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.
Associate Director, Project Manager
Palo Alto, CA jobs
About
Summit
Summit
Therapeutics
Inc
is
a
biopharmaceutical
oncology
company
with
a
mission
focused
on
improving
quality
of
life
increasing
potential
duration
of
life
and
resolving
serious
unmet
medical
needs
At
Summit
we
believe
in
building
a
team
of
world
class
professionals
who
are
passionate
about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKI HARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC Colorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The Associate Director of Project Management sits within the Program Management and Business Strategy department and is pivotal in contributing to a fit for purpose PMO and driving cross functional execution and operational excellence across oncology development programs particularly Phase 2 and beyond The Associate Director will serve as a strategic integrator aligning corporate and clinical development goals with functional execution across departments such as Clinical Operations Development Biometrics Regulatory Clinical Pharmacology Biomarker Strategy Bioanalytical New Indication Planning Quality IT and Compliance This role will be responsible for building and refining infrastructure and processes that support scalable transparent and adaptive program execution This includes dashboarding process improvement and continuous monitoring to ensure visibility accountability and agility as the organization grows and our pipeline evolves Role and Responsibilities Project ManagementDevelop integrated project plans timelines and templates from scratch tailored to program cross functional and governance needs Drive execution of project milestones proactively identifying risks and mitigation strategies Ensure alignment between functional execution and strategic program goals Lead and manage ad hoc cross functional workstreams on specific initiatives Functional IntegrationServe as a project management strategic liaison to 12 functional departments eg Clin Ops Biometrics Clinical Quality Clin DevTranslate functional needs into actionable infrastructure and project plans Support functional teams in achieving operational excellence and compliance Process Improvement & PMO development Design and implement scalable adaptable processes that support program execution Lead initiatives to improve operational efficiency transparency and agility Ensure all infrastructure initiatives are documented and integrated into the PMO library Apply continuous monitoring and feedback loops to refine processes as the organization evolves Dashboarding & VisibilityDevelop and maintain dashboards using Smartsheets and other tools to track timelines deliverables and risks Ensure real time visibility into project status for leadership and stakeholders Champion data driven decision making through effective reporting and visualization Leadership & CollaborationNavigate ambiguity with confidence and clarity Be a self starter while knowing when to seek input and guidance Lead diverse teams in both direct and matrixed environments Foster strong relationships across functions and levels of the organization All other duties as assigned Experience Education and Specialized Knowledge and Skills EducationMinimum of a Bachelors degree preferably in a scientific or business discipline Masters degree preferred ExperienceMinimum of 8 years in a pharmaceutical company or CRO Direct experience in oncology drug development Phase 2 and beyond Expertise in drug development financial operations and strategic planning Strong project management experience PMP certification preferred Experience leading diverse teams in direct and matrixed environments Technical SkillsProficiency in Smartsheets and dashboarding tools Experience with systems such as Veeva SAP CTMS Janus Power BI highly preferred Solid understanding of financial aspects of clinical operations Prior experience in resource planning capacity management and project baselining highly preferred Ability to derive key insights on complex topics and deliver verbal and written communications accordingly Core CompetenciesEffective leadership and team building skills Excellent communication analytical and conceptual skills Strong planning and organizational abilities with a focus on results Performance driven with the ability to lead and deliver in complex environments Skilled in recommending and implementing process improvements Capable of managing multiple projects simultaneously The pay range for this role is 153000 180000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team at recruitingsmmttxcom to obtain prior written authorization before referring any candidates to Summit
Construction Associate Project Manager
Lancaster, MN jobs
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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
* Applies the highest quality standard in all areas of responsibility
* Demonstrates strong client service skills, teamwork, and collaboration
* Proactively plans and multitasks to maximize productivity
* Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
* Technical understanding of building construction and engineering
* Demonstrated experience with full-project life cycle from bidding through completion
* Diagnose problems and propose solutions
* Manage staff and outside contractors
* Abiltiy to read, understand, and execute construction specifications and plans
* Manage construction budgets
* Manage multiple projects concurrently
* Communicates effectively with internal and external contacts
* Assist in managing subcontractors
* Review construction drawings for accuracy
* Represent owner in project meetings
* Review pay applications
* Participate in continuing education (Conferences, ABC classes, internal trainings)
* Assist in designing new or renovated building spaces
* Participate in Real Estate due diligence
* Assist or manage purchasing of equipment or fixtures
* Travel as needed to support remote sites
* Support Senior / Principal PM or equivalent with project management
* Assist lead PM with activity schedule preparation
* Manage single- and multi-prime contractor projects with support from more experienced PM/leadership
* Assist with preparation of bid documents
* Assist with review of bids
* Prepare site communications to impacted entities / people
* Communicates effectively with client staff members
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
Qualifications
* High school diploma or equivalent;Technical degree in a trade discipline like engineering, fabrication, sheet metal design, etc is preferred
* Minimum 2 years of previous construction experience required
* Experience with building design, previous laboratory work experience
* Experience using Procore Construction Management platform preferred
* Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to Lancaster, PA are encouraged to apply.
Excellent full-time benefits including:
* Comprehensive medical coverage, dental, and vision options.
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Associate Project Manager: Biopharmaceutical Product Testing
Lancaster, MN jobs
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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 50 countries. 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.
Job Description
Role Overview
The GMP Testing Project Manager 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
* Project Management
* 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
* 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 project management 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. with additional hours, as needed. 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.
Commercial Associate Project Manager (Onsite Required)
Rockford, IL jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Commercial Associate Project Manager**
Assists with designated execution of customer projects and ongoing order fulfillment to ensure that objectives are accomplished within prescribed time frame and budget while adhering to applicable pharmaceutical regulations. Supports maintaining exceptional client satisfaction and superior business performance metrics.
**Essential Duties and Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ Create and maintain the customer specific production schedule for both long-term forecast and short-term production demands; follow up on the workflow through each step to maintain schedule integrity and communication. Communicate any On-Time Delivery risks.
+ Ensure accurate forecasts are in place for monthly Material Requirements Planning runs.
+ Understand and interpret application of purchasing authorization from the supply agreement; Place purchase order requisitions with procurement and work with them to expedite, delay or cancel if necessary; ensure on-time delivery and communicate any issues with on-time delivery. Support fulfillment and application of Material Requirements Planning tools in ERP system though forecast and order management.
+ Maintain an understanding of the document creation process which includes, but is not limited to, the following: Lot/Expiration form creation, material receipt/release, batch record preparation and ERP work order creation.
+ Track On-Time Delivery and document creation metrics for the appropriate business units
+ Manage and monitor purchase order status' within the PCI-Rockford organization to ensure On-Time Delivery metrics are met
+ Work with the customer to ensure correct components and artwork changes; communicate price variances with management.
+ Review and approve documentation including specifications and batch records, as required.
+ Create bill of materials, component item number and ensure overall data entry accuracy and management.
+ Monitor and facilitate timely Releases of finished goods. Assist in the preparation of shipment documents.
+ Assist with disposition of Nonconforming materials and Component Variance Notifications.
+ Order and ensure shipper labels and print mats are ready for maintenance and production requirements
+ Ensure obsolete materials are dispositioned and invoiced after a component revision or the end of a project. Responsible for ensuring the destruction of obsolete materials & expired materials as well as providing the Certificate of Destruction to the customer (as required).
+ Work with Incoming Quality Department to ensure timely release of components and bulk.
+ Allocate and manage lot specific materials to the Work Order.
+ Maintain optimal component inventory level for customer owned inventory. Provide continuous support to Project Manager and team for day-to-day internal problem solving and trouble shooting.
+ Training and onboarding for new employees within same role, as requested. This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
+ Attendance to work is an essential function of this position.
+ Performs other duties as assigned by Manager/Supervisor.
**Qualifications:**
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Associate's Degree in a related field and/or 1-3 years related experience and/or training.
+ College Level Mathematical Skills
+ Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
**Preferred:**
+ Able to set and achieve challenging goals.
+ Ability to adapt to a changing work environment.
+ Ability to display excellent time management skills.
+ Ability to identify and resolve problems in a timely manner.
**For Illinois residents** : The hiring rate for this position is $56,720-$64,000 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
**\#LI-JM1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled