Veranova Pharma Jobs in Usa

SAP Product Cost Manager, 170k plus bonus, Princeton, International Pharma Company

US CITIZEN OR GREEN CARD ONLY

US CITIZEN OR GREEN CARD ONLY

HYBRID MODEL, 3 DAYS ON SITE

NO REMOTE WORK

MUST HAVE BEEN THROUGH 3 TO 4 FULL LIFECYCLE SAP IMPLEMENTATIONS

• Own the implementation, design, configuration, and continuous enhancement of SAP S/4HANA Product Costing (CO-PC) including standard cost planning, Material Ledger, cost component split, variance analysis, Margin Analysis (CO-PA), and Cost Center Accounting.
• Implement and manage cost center planning, activity type planning, overhead costing sheets, template allocations, and cost assessments/distributions. Support budgeting cycles and financial forecasts integrated with SAP S/4HANA.
• Manage and govern seamless integration between Controlling and related modules such as Financial Accounting (FI), Production Planning (PP), Materials Management (MM), and Sales & Distribution (SD) to ensure seamless data integration, process alignment and accurate cost flows.
• Oversee and support day-to-day, month-end and year-end processes, which include cost allocations, assessments, project settlements, revaluation, and variance analysis, to ensure accurate and timely financial reporting. Additionally, manage the costing processes, such as cost rollups, inventory valuation, cost estimates, and revaluation of consumption. Ensure the accuracy of the Material Ledger and actual cost flows across multiple plants, company codes, and currencies. 20%
• Act as the SME and escalation point for CO-PC, CO-PA and other CO related incidents. Identify gaps and opportunities for process standardization and automation within SAP CO-PC. Lead process improvements to enhance efficiency, accuracy, and scalability. Perform root cause analysis, recommend corrective actions, and develop functional specifications for RICEFW objects, perform unit/integration/UAT testing and coordinate with developers for RICEF object resolution (Reports, Interfaces, Conversions, Enhancements, Forms).
• Conduct FIT/GAP analysis, develop functional specifications for RICEFW objects, perform unit/integration/UAT testing, and support cutover and go-live activities. Provide ongoing support for system stabilization and continuous improvement initiatives.
• Collaborate with finance, operations, and IT stakeholders to translate business needs into technical solutions. Actively contribute to SAP S/4HANA transformation projects, S/4HANA roadmaps, upgrades, and process improvement initiatives with focus on CO and Product Costing streams.
• Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Knowledge, Skills and Abilities (KSA)

• Exceptional problem-solving, communication, and business engagement skills.
• Excellent communication and presentation skills
• Ability to work on projects with cross functional teams, external resources, and PMO.
• Manage business users independently, be self-motivated, proactive and a team member.
• Ability to embrace new technologies and adopt to an evolving environment.
• Ability to adopt flexible schedule to meet multiple time-zones for meetings with peers and stakeholders.

Qualifications/ Background Experiences

• Bachelor’s degree in Finance, Accounting, or equivalent experience.
• Minimum 10 years of SAP experience with deep focus on Product Costing (CO-PC) and Profitability Analysis (CO-PA).
• Demonstrated experience working in complex, global SAP S/4HANA environments.
• In-depth knowledge of SAP CO modules (CO-PC, CO-PA, PS, CCA) and integration with FI/MM/PP.
• Deep understanding of cost flows, costing variants, overhead calculations, and inventory valuation.

POSITION SUMMARY:

The Instrumentation and Calibration Engineer has the responsibility for ensuring the site’s production instruments are operating at optimal levels and properly maintained to data collection in an FDA regulated environment. The position will be primarily responsible for ensuring all instruments are maintained in a calibrated state. Additionally, the Engineer will support general troubleshooting of production equipment/utilities, and asset management.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILITIES.

• Support the Preventive Maintenance (PM) program through the creation of new PM tasks, evaluation of existing PMs for technical relevance to current asset problems.
• Help create Standard Operating Procedures (SOPs) for equipment operation, engineering analyses, PM and calibration tasks, that adhere to FDA and cGMP requirements.
• Support the management of the calibrations on production instruments, such as temperature sensors (RTDs/resistance thermometers), pressure sensors (electronic manometers, gauges), and other transmitters.
• Support root cause investigations to a detailed level required for an FDA regulated/cGMP environment, and translate these root causes to effective CAPAs that mitigate equipment risk.
• Assesses and monitors equipment for reliability of operation implementing necessary improvements
• Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplier operating and maintenance manuals, installation and operational qualification.
• Translate data from Root Cause Centered Maintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance.
• Maintain calibration records, and qualification of calibration contractor.
• Manages risk to achieve organization's strategic objectives in areas of environmental health and safety, asset capability, quality, and production.
• Conducts risk analyses routinely when production equipment is functioning outside of expected parameters
• Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas.
• Runs process improvement projects from design thru implementation. Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks.
• Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs
• Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization
• Participates in and execute qualification and validation of equipment and processes

EDUCATION/EXPERIENCE.

• Bachelor’s degree in an engineering discipline and 3 years of experience in a related or similar field, or
• Associate’s degree in an engineering or scientific discipline and at least 5 years of experience.

JOB COMPETENCIES.

• Analytical thinking: the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.
• Technical aptitude: a strong understanding of the systems, equipment, and processes at hand. This includes knowledge of the engineering principles and specific systems used at an organization.
• Mechanical aptitude: an understanding of how mechanical components fit together and support the function of equipment. Demonstrated curiosity for how production equipment functions.
• Problem-solving: the ability to think creatively and come up with innovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root causes and create effective corrective actions.
• Communication: the ability to explain technical concepts in a clear and understandable manner, as well as the ability to collaborate effectively with others. The ability to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.
• Time management: the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing. Preferred experience in the Agile Project Management System.
• A continuous improvement mindset: identifying and implementing ways to continuously improve reliability.
• An understanding of lean manufacturing principles, and applying Six Sigma concepts to chemical manufacturing.
• Safety-conscious: the ability to identify potential hazards and take the necessary steps to mitigate them.
• Knowledge of CMMS system and functions
• Knowledge of the regulations and their application to instruments that gather GMP data in a production environment.

Hybrid Onsite Schedule In office T, W, Th; Remote M, F

Job Description: Data Analyst – Global Patient Access Program (GPAP)

Location: North Chicago, IL, USA (Hybrid eligible), AP30

Overview: The Data Analyst for the Patient Assistance Program (PAP), supporting GPAP’s data transformation and governance, will be instrumental in building and maintaining the backbone of automated reporting and KPI dashboards. This role ensures a single source of truth for GPAP operations, drives analytics innovation, and supports the integration and consistency of data across the program. You’ll collaborate closely with workstream leaders, lead in bi-weekly scrum sessions, and deliver insight-rich, timely outputs for senior leadership.

Key Responsibilities:

• Develop, automate, and maintain standardized PAP reporting, KPI dashboards, and ad hoc analytics tools using Tableau, Excel, and Snowflake.

• Lead twice-weekly Scrum sessions with workstream team members, ensuring progression of data tasks, intake of new data requests, and alignment on analytics approaches in a Smart Sheet-driven, agile environment.

• Ensure data consistency, quality, and accuracy across all platforms, supporting GPAP governance and the creation/control of the 'source of truth.'

• Enable and facilitate self-service dashboards and reporting marts for internal and external stakeholders.

• Collaborate with cross-functional partners (BTS, ACA, GPAP, Steer Co) to support program data needs, forecasting, and reporting methodologies.

• Support quarterly and weekly reporting processes—including application, shipment, and claim-level analytics.

• Partners with data lead to document extraction methods, automate/accelerate reporting, and track program impacts, escalations, and business intelligence.

• Identify new opportunities for advanced analytics or insights to increase PAP operational efficiency and program sustainability.

Qualifications:

• Bachelors in a relevant field (Analytics, IT, Business, Data Science, or related)

• 3-5 years’ experience in data analytics, reporting, or business intelligence in healthcare, pharma, or related industry

• Advanced proficiency in Tableau and Excel; experience with Smart Sheet and Snowflake (SQL skills required)

• Demonstrated experience leading agile meetings (scrum/project management preferred)

• Strong attention to detail, data integrity, and quality control

• Experience in KPI development, dashboard design, and self-service reporting

• Effective communicator with ability to drive cross-team consensus and present findings to varied audiences

• Collaborative mindset, able to work in fast-paced, matrixed environments

• In office Tues, Wed, Thurs

Preferred:

• Experience in patient assistance programs or US healthcare market access

• Familiarity with organizational data governance or compliance requirements

Be part of a team unlocking strategic impact through advanced analytics, automation, and insight-driven transformation. Shape the way data informs patients’ access and program value across a global organization while enjoying professional growth in a supportive, inclusive culture.

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

Job Description:

The Logistics Specialist will coordinate inbound and outbound logistical operations, including inventory management, warehousing, and limited transportation activities, to ensure a consistent and efficient supply of goods. This role requires a proactive logistics facilitator who can align distribution processes with internal and external customer requirements, regulatory standards, and budgetary goals.

Key Responsibilities:

• Manage daily logistics operations to support production and distribution schedules

• Oversee inventory control and ensure accuracy across warehouse systems

• Coordinate transportation of raw materials, components, and finished goods (minimal focus)

• Ensure compliance with regulatory and safety standards

• Collaborate cross-functionally with procurement, planning, and quality teams

• Utilize SAP to manage logistics workflows, inventory, and reporting

Requirements:

• Bachelor’s degree (Supply Chain, Business, or related field preferred)

• 6+ years of logistics experience

• 4–6 years of experience in warehouse and distribution operations

• 4–6 years of hands-on SAP experience (required)

• Strong communication and problem-solving skills

• Experience in regulated industries (pharma/biotech) is a plus

Executive Relationship Officer or EXRO (yeah, we made the title up! and you get to write the job description)

This opportunity is for the person who's had success and wants to help build lasting change as a Strategic Pharma Industry Advisor.

Intrigued?

In a nutshell, it's about helping to bring a transformational technology disruptor to market.

Luminari has built a proprietary AI LLM that compresses clinical trial protocol development from an average of 8 weeks to just 8 minutes—WITH regulatory-grade accuracy, trained on 10,000+ FDA submissions. This shift isn't an incremental improvement; it's a fundamental transformation of how drugs reach patients.

We are looking for an Industry Savvy Champion. This opportunity is not 'a job' or 'a consulting gig', not even 'a board member seat' yet. We're looking for someone to champion our effort, open a few key doors, validate us with credibility we haven't had a chance to prove emphatically just quite yet, and help us build something that becomes the STANDARD in Pharma AI.

You Have:

• Launched drugs - you understand the regulatory process from IND to NDA/BLA
• Built or managed clinical operations teams at scale - you've overseen 10+ simultaneous trials.
• Navigated FDA, EMA, and global regulatory agencies- you know how to get things approved.

You're currently interested in:

• The AI revolution, but skeptical of the hype, and you want to see the real product before you commit.

You believe:

• Your decades of experience are worth more than a consulting day rate—they're worth equity in something transformational.

You bring:

• 20+ years in Pharma, biotech, or CROs. You've launched products, navigated regulatory nightmares, built teams, closed partnerships, and probably have a Rolodex that would make a McKinsey partner jealous.
• Motivation beyond money - you're financially stable, maybe thinking about retirement, or already there.
• A legacy mindset - you want to build something that outlasts you.
• A drive where Impact matters more than title - you'd rather change the industry than manage a P&L.

This opportunity is:

·        This is an invitation to co-build the infrastructure that will reshape how the pharmaceutical industry develops drugs.

• Real technology and the product – LumiPath™ is built, it works, and it's demonstrably better than the status quo.
• Real mission - every protocol we help generate gets therapies to patients faster.

The Luminari CRO Team will work behind you:

• An experienced CEO and a team that has over 50 years of deep, aligned pharma experience.
• We are NOT a "couple of Stanford kids who think 'healthcare is broken' and have never filed an IND".
• A Team that has more than a two (2) year head start in AI technology for regulatory solutions.

What you get:

In return, you get equity in what industry analysts believe will become a multi-hundred-million-dollar company, visibility as one of the architects of the AI-powered clinical trial era, and the satisfaction of knowing you helped accelerate therapies to patients who are running out of time. And, oh yes, a way to put the finishing touches on your professional legacy in this space.

How to Start the Conversation

Rather than the traditional resume model, simply send us an email with:

1. Why are you interested in this opportunity, and why now? (75-100 words max, or be different and send a 120 sec. video): You could do many, many other things with your time and credibility. Why are you interested in this role?
2. Tell us about your biggest skepticism (100 words max): What's the thing that makes you think "this probably won't work"? - We'd rather address it upfront.
3. A link to your LinkedIn profile and/or personal website.

Send to:

Subject: "Champion Role - [Your Name] - Let's Talk"

We'll set up a call within 48 hours if there's a mutual fit.

Check us out on the web: Luminari or visit our LinkedIn page: Luminari CRO

Luminari CRO

8 weeks to 8 minutes.

Let's make it the standard.

Associate Project Leader

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower-level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Associate Project Leader:

-Bachelor's degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO;

-Master's degree with at least 4 years of experience within pharma and/or CRO;

-PhD with at least 1 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles appropriate to the position with a typical tenure of at least 1 year management experience in a research environment.

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  Highly motivated with ability to work independently and as part of a multi-disciplinary team
  Strong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Project Leader: Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  Highly motivated with ability to work independently and as part of a multi-disciplinary team
  Strong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Role Summary:

Insight Global is seeking an experienced Equipment Systems Integration/Configuration Engineer with strong automation/controls awareness and biotech manufacturing experience for one of our biotech clients to support CART production in central, NJ. This role will ensure equipment is correctly configured, and ready to run GMP manufacturing during commissioning and qualification activities while supporting mindset towards Pharma 4.0 and improved data accessibility.

Key Responsibilities

Equipment Configuration & Readiness Program Creation.

Configure and verify equipment parameters, protocols, and recipes on an ongoing basis

Review and configure alarm settings, audit trails, and user access.

Ensure equipment is “manufacturing-ready” and in a validated state after updates.

Required Experience

Experience configuring or supporting biotech/pharma manufacturing equipment.

Working knowledge of SCADA/Historian (e.g. OSI PI).

Familiarity with automation fundamentals (PLC/HMI/Equipment basics; no coding needed).

Understanding of GMP, QMS, GAMP5, Data integrity, and Change Management policies.

Hands-on troubleshooting skills across equipment, networks, and integrations.

Plusses

Experience with ISA-95 or ISA-88.

CAR-T / Biotech equipment vendor experience (isolators, LFGs, incubators, cold storage).

Pharma 4.0 or digital transformation projects.