Keysource Pharmaceuticals Jobs in Usa

Location: Remote or Hybrid

Hybrid – if within 50 miles of the Malvern, PA, or East Windsor, NJ office

• In-office Tuesdays, Wednesdays, and Thursdays
• Work from home on Mondays and Fridays

Travel: Limited, periodic travel expected—generally around one trip per month, with some flexibility based on business needs. Extensive or continuous travel is not anticipated.

Competitive guaranteed annual base salary + uncapped commissions

Comprehensive Benefits (Medical, Dental, Vision, 401k w/company match)

HMP Global is the omnichannel market leader in healthcare events, education, and insights with a mission to improve patient care. With a dominant position in several therapeutic areas, including Oncology, Psychiatry & Behavioral Health, Cardiovascular, Wound Care, and Public Safety, we deliver information and education to healthcare professionals through 400+ global, regional, and local events and reach over 4 million users monthly through digital networks and social channels.

We are seeking a business development professional to drive revenue for our market access brand(s), First Report Managed Care. You will partner with pharmaceutical clients to understand their objectives and present solutions. Our delivery team develops evidence-based solutions that identify gaps, analyze key performance metrics, and drive lasting results that build engaged clinician communities through education, information, and networking.

Responsibilities

• Ability to demonstrate knowledge and benefits of HMP Global’s products and services to meet client objectives.
• Work closely with clients to understand their needs, budget, and timeframe.
• Develop and grow a high-quality pipeline of new contacts as targeted potential clients through ongoing networking and relationship-building.
• Maintain consultative relationships with clients to ensure that they are maximizing the value of our products and services.

Qualifications

• Bachelor’s degree (required)
• Experience working a full sales cycle, from prospecting to closing
• Prior experience working at a medical communications agency (preferred)
• Exceptional presentation skills – in-person and virtual
• Demonstrated knowledge of the pharmaceutical industry
• Prior experience calling on pharmaceutical companies at the executive level
• Competitive in nature
• Ability to speak with confidence and poise
• Assertive, positive, and persistent communication style
• Naturally outgoing and articulate individual who thrives in social settings
• Skilled at objection handling
• Exceptional time management and organizational skills
• Consistent and verifiable work history
• Valid driver’s license

Please follow HMP Global on LinkedIn for news and updates

Professional Experience

Senior Manufacturing Support Engineer

Pharmaceutical Manufacturing Operations

Billerica, MA

Manufacturing Equipment Support

• Provide advanced troubleshooting and rapid recovery support for pharmaceutical manufacturing equipment to minimize downtime and maintain production schedules.
• Serve as Subject Matter Expert (SME) for critical equipment including isolators, vial filling lines, lyophilizers, sterilizers, washers, and packaging systems.
• Monitor process operations to ensure compliance with manufacturing specifications and cGMP regulations.

Process Equipment Reliability

• Maintain operational readiness of sterile filling and process equipment supporting continuous manufacturing operations.
• Troubleshoot complex issues involving mechanical, electrical, automation, and process systems.
• Operate production equipment for setup, testing, or manufacturing support as required.

Validation & Compliance Support

• Support validation maintenance programs and equipment re-qualification activities.
• Assist Validation Engineers during FAT, SAT, IQ, OQ, and PQ activities for new or modified equipment.
• Maintain equipment documentation and records to support validated manufacturing operations.

Quality & Regulatory Support

• Support change control, deviations, and CAPA investigations within TrackWise or similar systems.
• Ensure compliance with FDA regulations and current Good Manufacturing Practices (cGMP).
• Assist with maintenance SOP improvements and documentation updates.

Engineering & Process Support

• Support Manufacturing Engineers with retrofit, improvement, and upgrade projects for manufacturing and critical systems.
• Provide mentorship and technical support to peers within engineering and maintenance teams.

Operational Support

• Participate in 24/7 on-call support for critical manufacturing equipment.
• Perform non-routine and off-hours troubleshooting activities when required.
• Ensure safe work practices and adherence to company safety policies.

Technical Skills

Systems & Software

• CMMS Systems
• TrackWise
• MasterControl
• LMS
• Building Automation Systems
• Microsoft Office Suite

Technical Skills

• Mechanical Systems
• Electrical Systems
• Automation Systems
• Equipment Maintenance
• Process Equipment Troubleshooting
• Engineering Drawings & Schematics

Education

Bachelor of Science – Mechanical Engineering (Preferred)

or equivalent engineering experience

Associate Degree – STEM Field (Optional)

High School Diploma or Equivalent

Certifications & Training

• cGMP Training
• HAZMAT Training
• State Boiler License (Preferred / Obtain within 6 months)
• Electrician License (Preferred)
• Technical Certifications (Preferred)

Additional Qualifications

• Knowledge of aseptic manufacturing techniques
• Experience in pharmaceutical plant operations and maintenance environments
• Ability to read and create engineering drawings and schematics
• Proficient in hand tools, power equipment, and production machinery
• Valid Driver’s License

Physical & Work Environment

• Ability to lift up to 70 lbs
• Work in manufacturing, laboratory, and warehouse environments
• Exposure to noise, temperature variations, and controlled radiation levels
• Use of PPE including safety shoes, glasses, and gloves

Project Manager, GxP Quality Assurance

W2 Contract

Pay Rate: $80 - $90 per hour

Location: Redwood City, CA - Hybrid Role

Duties and Responsibilities:

• Coordinate and lead cross-functional Quality projects, including QA process improvement and enhancement initiatives, to ensure alignment with business objectives and delivery against established timelines.
• Contribute to the planning and execution of strategic initiatives within the GxP Quality Assurance function to strengthen operational effectiveness and compliance.
• Coordinate and facilitate quality & cross-functional meetings, including agenda development, documentation of key decisions, and tracking action items through completion.
• Develop and maintain comprehensive project documentation, including project timelines, risk registers, action item trackers, dashboards, and status reports to ensure transparency and accountability.
• Identify project risks, gaps, and process inefficiencies, and proactively facilitate mitigation strategies to ensure compliance, operational continuity, and successful project outcomes.
• Coordinate inspection and commercial readiness activities from the Quality team to support organizational objectives, including global expansion.

Requirements and Qualifications:

• Strong project planning, scheduling, and resource management skills.
• Excellent communication and presentation skills, with the ability to present to senior leadership.
• Strong stakeholder engagement and alignment skills.
• Experience with developing clear, visually compelling PowerPoint presentations with strong narrative flow and impactful visuals.
• Experience working in Pharmaceutical, biotech companies, and partnering with key stakeholders, including Regulatory, Clinical, CMC, Manufacturing, and IT.
• Knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes

Preferred Qualifications:

• Strong analytical skills with the ability to interpret quality metrics and identify trends and risks.
• Strong leadership, problem-solving, and organizational skills.
• Ability to work effectively in a fast-paced, cross-functional, and regulated environment.

Desired Skills and Experience

Project Management, GxP Quality Assurance, Quality Management Systems (QMS), GxP Compliance, Pharmaceutical Quality Systems, Biotech Quality Assurance, Cross-Functional Project Leadership, Quality Process Improvement, Strategic Initiative Execution, Risk Management & Mitigation, Quality Metrics Analysis, Inspection Readiness, Commercial Readiness, Stakeholder Management, Regulatory & Clinical Collaboration, CMC Collaboration, Manufacturing Quality Coordination, IT Collaboration in Regulated Environments, Project Planning & Scheduling, Resource Management, Quality Documentation Management, Project Timelines & Roadmaps, Risk Registers, Action Item Tracking, Project Dashboards, Status Reporting, Meeting Facilitation, Agenda Development, Decision Documentation, Process Optimization, Operational Excellence, Compliance Oversight, PowerPoint Presentation Development, Executive Communication, Data Interpretation & Trend Analysis, Problem Solving, Leadership in Regulated Environments

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

Strong knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes.

The Opportunity: Project Manager GxP Quality Assurance

• Coordinate and lead cross-functional Quality projects, including QA process improvement and enhancement initiatives, to ensure alignment with business objectives and delivery against established timelines.
• Contribute to the planning and execution of strategic initiatives within the GxP Quality Assurance function to strengthen operational effectiveness and compliance.
• Coordinate and facilitate quality & cross-functional meetings, including agenda development, documentation of key decisions, and tracking action items through completion.
• Develop and maintain comprehensive project documentation, including project timelines, risk registers, action item trackers, dashboards, and status reports to ensure transparency and accountability.
• Identify project risks, gaps, and process inefficiencies, and proactively facilitate mitigation strategies to ensure compliance, operational continuity, and successful project outcomes.
• Coordinate inspection and commercial readiness activities from the Quality team to support organizational objectives, including global expansion.

Required Skills, Experience and Education:

• Strong project planning, scheduling, and resource management skills.
• Excellent communication and presentation skills, with ability to present to senior leadership.
• Strong stakeholder engagement and alignment skills.
• Experience with developing clear, visually compelling PowerPoint presentations with strong narrative flow and impactful visuals.
• Experience working in Pharmaceutical, biotech companies and partnering with key stakeholders including Regulatory, Clinical, CMC, Manufacturing, and IT.
• Knowledge of Quality Assurance principles within the pharmaceutical/biotech industry, including GxP regulations and QMS processes

Preferred Skills:

• Strong analytical skills with ability to interpret quality metrics and identify trends and risks.
• Strong leadership, problem-solving, and organizational skills.
• Ability to work effectively in a fast-paced, cross-functional, and regulated environment.

• Develops and grows business relationships with targeted customers within the assigned geography.
• Develops a detailed local market business plan that focuses on the strategic growth opportunities to include tactical plans and a measurement system to capture results and insights.
• Utilizes all available resources to educate HCP and staff on client products for the purpose of growing market share.
• Understands and manages the patient journey utilizing the appropriate resources available
• Utilizes pre-call planning, account management, and consultative selling skills, as well as clinical expertise to enhance the business.
• Proactively analyzes and applies qualitative and quantitative market data to identify business opportunities and priorities
• Builds compliant cross-functional collaborative relationships with our MSL, Managed Market and Reimbursement teams to deliver high quality service to physicians and other healthcare professionals
• Works with high degree of independence and in a professional and compliant manner
• Travel up to 90% of the time
• All other duties as assigned
  
  

• Bachelor’s degree
• A passion for serving patients and a desire to help build a company
• 2+ years of Pharmaceutical/Biotech experience
• Experience in Specialty markets desired, Rare Disease not required
• Demonstrated and consistent track record of successful sales performance
• Excellent communication skills, business acumen, and track record of cross-functional collaboration required
• The ability to travel, which includes overnight / weekend travel, up to 90% of the time, is required. The amount will depend on the specific territory assignment.
• Required to possess and maintain a current, valid driver’s license in state of residence and a clean driving record
• Fosters an entrepreneurial spirit with a focus on ownership and accountability to maximize individual and corporate goals
• Demonstrates daily the core values of relentless, confidence with humility, courageous, insights to impact, and togetherness
• Be a patient focused problem solver, be evidence based, and show a willingness to be bold
• Demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
• Ability to have fun and work together as ONE team!
  
  

• Strategic Leadership:
  • Able to define a vision for a site of approximately 200 staff members, including the development of a 3 to 5 year operating plan
  • Prior experience managing responsibility of the P&L and balance sheet for a manufacturing site.
  • Deliver annual revenue, profit, EBITDA, and cash targets through effective P&L management.
  • Execute capital projects on average of +$10M to ensure facilities, equipment, and systems meet production demand and compliance requirements.
  • Develop and execute site master plan which includes building talent capabilities that results in the site meeting branded large pharma industry standards to facilitate new business.
• Regulatory & Compliance:
  • Ensure strict adherence to cGMP, FDA, and DEA regulations for controlled substances.
  • Maintain FDA audit readiness and compliance with OSHA, EPA, DEA and other regulatory agencies.
• Process Excellence & Operational Performance:
  • Drive process improvement initiatives, lean manufacturing, and digital transformation to optimize throughput and reduce costs.
  • Assess site operations and drive execution of cost reduction initiatives to improve productivity and profitability of products
  • Implement best practices for manufacturing
  • Deep understanding in Process Safety Management, Environmental understanding, including wastewater treatment plant operations and security programs.
  • Oversee ERP and compliance systems (including D365) for operational efficiency.
• Commercial & Customer Focus:
  • Partner with Commercial teams to define and execute strategies for revenue growth and customer satisfaction.
  • Ensure timely delivery of products in compliance with regulatory requirements.
• People Leadership:
  • Recruit, develop, and retain high-caliber talent through succession planning and performance management.
  • Demonstrates deep understanding on cultural transformation
  • Foster a culture of engagement, accountability, and continuous improvement.
• Business Development:
  • Enable the site to deliver late -phase/commercial CDMO programs that include the acquisition of new customers, tech transfer and scale up production.
  • Participate in strategic initiatives including market expansion, technology alliances, and evaluation of new products.
  • Support acquisition and rationalization activities as needed.
    
    

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field (advanced degree preferred).
  
  

• 15+ years in API small molecules pharmaceutical manufacturing leadership roles, with proven expertise in cGMP, FDA, and DEA compliance for APIs and controlled substances.
• Proven experience in generics manufacturing with knowledge and capabilities to meet big pharma branded business.
• Demonstrated success in operational turnarounds, quality remediations, or start-up of manufacturing facilities.
• Strong background in process optimization and continuous improvement methodologies.
  
  

• Exceptional leadership, communication, and change management skills.
• Detail oriented, advance analytical capabilities and high learning agility
• Ability to manage complex operations and deliver results in a dynamic environment.
• Understanding transactional process improvements
• Understand how to develop and implement operating mechanism and meeting structure to manage operations at the site, including the definition and implementation of KPIs and tier meetings.
  
  

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you do not meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
  
  

Discover Veranova:

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 

Role Overview:

Perform calibration, maintenance, troubleshooting, and installation of plant and lab instrumentation and control equipment. Enter and maintain repair, maintenance, and calibration data into computerized maintenance management systems.

Core Responsibilities:                                                              

• 
  
• Collaborate with cross-functional teams to drive impactful projects. 
  
• Foster a culture of openness and creatively, encouraging diverse perspectives. 
  
• Manage and execute the calibration program for both the Devens and North Andover sites.
  
• Perform calibration scheduling and history tracking utilizing Computerized Maintenance Management Systems.
  
• Install, maintain, and troubleshoot plant and lab instrumentation and control equipment.
  
• Maintain inventory levels for repair and critical spare parts.
  
• Manage activities and schedules for outside contracted services.
  
• Generate operating and maintenance Standard Operating Procedures (SOPs) for calibration and preventative maintenance activities.
  
• Develop equipment specifications and assist in process system designs.
  
• Conduct formal investigations of equipment and system problems using root cause process.
  
• Document all calibrations on Regulatory Asset Management System.
  
• Additional assignments/ duties to support team objective and contribute to the Veranova mission may evolve based on business needs. 
  

Qualifications: 

Required

• 
  
• High School Diploma or equivalent with 5-8 years related instrumentation experience within a pharmaceutical or chemical environment.
  
• AA in engineering or other related technical field with 2-5 years related instrumentation experience within a pharmaceutical or chemical environment.
  
• Demonstrate attention-to-detail, problem solving, and ability to multi-task
  
• Ability to physically enter equipment and confined areas for maintenance purposes
  
• Able to climb ladders and stairs and work from building roofs and heights
  
• Able to wear various types of respirators, protective clothing, and hearing protection
  
• Able to read and interpret sketches, diagrams, and blueprints
  
• Able to calculate various measurements using basic math skills.
  
• Experience working in an environment that utilizes safety improvement processes, lock-out/tag-out, hot work, and other OSHA based programs.
  
• Experience with Microsoft Office and other job-related software.
  

Preferred

• 
  
• Experience in a GMP environment
  
• Formal process control (DeltaV) and computerized Maintenance System experience
  
• Prior Forklift certification
  
• Specialized training in inventory control principles.
  

Special Factors 

• 
  
• While performing the duties of this job, it is required to stand, walk, use fingers and hands to feel objects, tools, or controls; reach with hands or arms; climb or balance, stoop, kneel, crouch, or crawl when necessary for job activity.
  
• Must be able to lift and/or move up to 50 pounds and occasionally life and/or move more than 100 pounds.
  
• Must be able to travel between Devens and North Andover locations when necessary.
  
• Must be able to work rotating shifts/hours when needed, including nights and weekends.
  

Pay Range – Hourly Rate: $35.00 - $45.00 per hour

Our Commitment:

• 
  
• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. 
  
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
  
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
  
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
  

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.  

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Company Overview:

Luye Pharma is fast-growing pharmaceutical company committed to advancing innovative therapies for Central Nervous System (CNS) disorders, with a primary focus on schizophrenia. Our pipeline includes promising new treatments such as Erzofri and Rykindo, which are set to launch in the U.S. market.

Position Summary:

In this role, you will collaborate closely with the US Head of Commercial Operations to design, implement, and manage data analytics and performance reporting systems. Your main responsibility will be to provide actionable insights that support decision-making and drive improvements in commercial outcomes. As the Manager of Commercial Analytics, you will serve as a key analytics partner for commercial leaders across sales, marketing, and operations in the US. You will offer valuable insights and recommendations to fuel growth, optimize field performance, and analyze market and patient trends. Additional key responsibilities include developing reporting processes and assisting with the coordination of Monthly Business Reviews, focusing on KPIs, forecasting variances, and updates to the Latest Estimate.

Report to: Head of Commercial Operation

Key Responsibilites:

• Develop and maintain performance dashboards and reports, integrating internal KPIs and external datasets to track business metrics, monitor progress toward sales goals, and evaluate operational performance.
• Conduct in-depth analysis of market trends and product performance to identify growth opportunities and risks.
• Evaluate overall business performance, including volume, market share, new patient starts, and KPIs, comparing actuals against forecasts and targets.
• Partner with Sales and Commercial Leadership to optimize territory alignments, call planning, and customer targeting, using analytical insights to improve sales coverage and operational efficiency.
• Assess performance and activity trends at sub-national levels to uncover opportunities, inefficiencies, and areas for improvement within the sales force.
• Prepare monthly business reviews, utilizing a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
• Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
• Assist in designing incentive compensation structures and performance metrics, including goal setting and attainment analysis.
• Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
• Provide support to field teams by addressing data and reporting requests, resolving inquiries, and delivering actionable insights for daily execution.
• Collaborate with cross-functional teams to develop demand forecast models.
• Conduct data analysis, reporting, and generate actionable insights to support commercial brand strategy and execution.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree
• 3-5 years of experience in relevant analytics roles within the pharmaceutical or life sciences industry.
• Strong understanding of the pharmaceutical industry and familiarity with third-party data sources (e.g., Symphony Health, IQVIA, etc.).
• Strong proficiency in Excel
• Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
• Experience with BI tools (Tableau, Power BI, Qlik etc.) preferred.

To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.

The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Luye Pharma is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Position: CT Tech/Rad Tech

Reports To: Clinic Supervisor

Function: Operations

Department: Clinical Services

Position Summary

CT Techs are responsible for performing CT imaging of patients within standards of practice and protocols.

Additional responsibilities include rooming patients and other Medical Assistant duties as necessary when not

conducting CT scans.

• Performs CT imaging procedures on appropriate anatomical regions in accordance with accepted

standards of practice and protocols.

• Maintains patient care, comfort, and safety during the exam.

• Performs equipment quality checks and troubleshoots problems.

• Relay to providers pertinent information prior to entering exam room.

2

• Observe and record the patient’s EMR encounter and accurate history of the visit.

• Properly use protective coverings to protect patients and themselves from excess radiation exposure.

• Follow the policies, procedures, and safety protocols established by the medical director or generated

by federal, state and local requirements, and by other oversight or accrediting agencies.

• Report any medical errors, mishaps, or near misses to the medical director or supervising physician.

• Implement the quality control processes required by the RadSite Standards.

• Educate patients about safety concerns inherent to ionizing radiation.

• Comply with all applicable federal, state and local regulations regarding the operation of the applicable

imaging systems.

• Maintain the current credentials necessary to operate the applicable imaging systems.

• Participates in educational opportunities to maintain job knowledge; reading professional publications.

• Sanitize exam room after each patient and deep cleaning weekly.

• Maintain inventory of medical supplies and non-sample pharmaceuticals, rotating/stocking

pharmaceutical closet; dispose of expired medications and ordering supplies and pharmaceuticals as

needed per established protocol.

• Works cohesively with all members of office and clinical team.

• Maintains detailed knowledge of EMR software and electronic systems as they relate to job functions.

• Maintains CT Tech Manual and binder documents to aid in external audits.

• Performs all other temporary and/or permanent duties as requested by the Clinic Supervisor and/or

providers.

• Performs Medical Assistant responsibilities as needed including rooming patients, taking vitals,

recording patient information in EHR and cleaning/stocking exam rooms.

• Identify, propose, and implement continual improvements to drive process efficiency, scalability and

innovation within the scope of your work that enhances our ability to achieve the ADVENT vision.

• Support the overall success of the organization and perform other related duties as requested by

leadership.

• Plan and adapt with business growth and strategy, cross-training where necessary to accommodate

different situations and locations.

• Follow all legal and compliance requirements, including HIPAA guidelines to maintain patient privacy.

Skills and Qualifications

• Completion of a Radiology or CT Tech program.

• ARRT Certified.

• Prior clinical experience.

• Strong communication skills and exceptional attention to details.

• Proficiency with computers and electronic medical records.

• Ability to work independently, producing high quality special imaging with little supervision.

• Must be willing to assist at various clinics within the market as needed.

EEO Statement:

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and Ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company

holidays.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

We are seeking an experienced Contract Project Manager to lead the design, construction, validation, and operational readiness of a new 503B Outsourcing Facility in Charleston, SC. This project involves the build-out of a modular cleanroom pharmaceutical manufacturing area, within an existing structure, to be compliant with U.S. FDA 503B regulations and current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211.

The Project Manager will oversee the full lifecycle of the facility build, including planning, vendor coordination, cleanroom installation, utilities integration, validation, regulatory readiness, and handoff to operations.

Key Responsibilities

Project Leadership & Execution

• Lead end-to-end execution of a modular cleanroom manufacturing and supporting structure area build.
• Develop and manage detailed project plans, budgets, schedules, and milestones.
• Coordinate cross-functional stakeholders including Engineering, Quality, Regulatory, Validation, Manufacturing, and Executive Leadership.
• Serve as the primary point of contact for contractors, cleanroom vendors, equipment suppliers, and consultants.
• Proactively identify risks and implement mitigation strategies to maintain timeline and budget.

Facility Design & Construction Oversight

• Oversee modular cleanroom design, fabrication, delivery, and installation.
• Ensure facility layout supports compliant workflows, material/personnel flows, and environmental controls.
• Coordinate mechanical, electrical, plumbing (MEP), HVAC, HEPA filtration, and critical utility systems (WFI, clean steam, compressed gases, etc.).
• Manage general contractors and subcontractors to ensure compliance with project specifications and cGMP requirements.

Regulatory & Compliance Alignment

• Ensure facility design and build align with Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable FDA guidance.
• Support readiness for FDA inspection and state Board of Pharmacy requirements.
• Collaborate with Quality and Validation teams to ensure proper documentation (URS, FS, DS, IQ/OQ/PQ protocols).
• Ensure adherence to cGMP standards and applicable USP chapters (e.g., USP , ).

Validation & Commissioning

• Oversee commissioning and qualification activities for cleanrooms and critical systems.
• Coordinate environmental monitoring setup and validation activities.
• Support process simulation activities for sterility assurance.
• Support development of SOPs related to facilities and equipment.
• Ensure successful facility turnover to Manufacturing and Quality teams.

Budget & Reporting

• Manage capital expenditure budget and vendor contracts.
• Track project performance metrics and provide regular executive-level updates.
• Ensure change control processes are followed for scope, schedule, and budget modifications.

Required Qualifications

• 7+ years of project management experience in pharmaceutical, biotech, or sterile compounding environments.
• Demonstrated experience leading construction or expansion of GMP-regulated manufacturing facilities.
• Direct experience with cleanroom builds (ISO 7/8 and higher classification preferred).
• Strong knowledge of FDA cGMP regulations and 503B outsourcing facility requirements.
• Experience managing modular construction projects preferred.
• Advanced proficiency with MS Project and/or other project management software.
• Proven ability to manage multi-vendor, cross-functional projects with aggressive timelines.
• Bachelor’s degree in Engineering, Construction Management, Life Sciences, or related field (PMP certification preferred).

Preferred Experience

• Prior experience building or remediating a 503B outsourcing facility.
• Experience preparing facilities for FDA inspection.
• Familiarity with Charleston, SC permitting and construction environment.
• Background in sterile injectable manufacturing.

Key Competencies

• Strong leadership and stakeholder management skills
• Excellent organizational and documentation practices
• Risk-based decision-making approach
• Detail-oriented with strong compliance mindset
• Ability to work on-site in Charleston, SC for critical phases

Deliverables

• Completed modular cleanroom facility delivered on time and within budget
• Fully commissioned and qualified GMP-compliant facility
• Inspection-ready documentation package
• Successful transition to operational manufacturing

This contract role offers a unique opportunity to lead the build of a state-of-the-art 503B modular pharmaceutical manufacturing facility from the ground up within an existing building. The ideal candidate thrives in complex, regulated environments and brings both construction execution expertise and deep GMP knowledge.

To apply, please submit your resume and a brief cover letter describing your relevant