(910) 332-1198

Featured Jobs All Jobs Search Jobs Submit Resume

Job Openings

Openings are listed for the following disciplines:
Quality Assurance / Quality Control (5)
Operations Management (2)
Validation (2)
Research & Development / Clinical Affairs (1)
Engineering (6)
Regulatory Affairs (1)
Sales, Marketing, Finance, and IT (1)

Quality Assurance / Quality Control
Director, Quality Assurance

The QA Director is responsible for managing the QA personnel and systems to assure compliant production and timely release of LJB products.


In charge of all QA activities and providing guidance to QA personnel to assure compliant products, including but not limited to the following:
• Oversee and manage the activities and function within Quality Assurance
• Lead regulatory inspection readiness, hosting and conducting regulatory inspection
• Oversee risk assessment to determine the level of risk and lead implementation of remediation and risk mitigation.
 Lot release activities and collaborate with functional areas to close records for this purpose
 Review facility monitoring QC data to assure compliance
 Review and approval of batch records and QC release data as applicable
 Review and approve deviations and drive for timely closure for timely release of batches
 Maintain Quality System requirements per FDA applicable regulations to Biologics to ensure continued compliance


Education and Experience
 BA/BS with science major, or an equivalent combination of education and experience
 Minimum of 15 years progressively responsible experience in the biologics or biotech industry. At least 10 years of direct QA oversight experience over QA activities.

Location  SW
Consultant  Phil Ellis

Vice President, Scientific and Regulatory Affairs
Provide high level scientific, regulatory affairs and quality systems support to the PDA membership. The position requires an advanced degree or equivalent experience, demonstrated management and organizational skills and the ability to anticipate association needs and fulfill them without being supervised. Substantial member, regulatory and industry contact is expected during normal duties, including frequent interactions with PDA Advisory Boards and Interest Groups, Industry Associations, and Standard Setting Organizations, as well as global regulatory agencies. Demonstrated ability to successfully communicate in multiple formats with the internal and external PDA Community is expected. Successful interpersonal skill set and experience managing and working in companies and committees/teams to meet goals. Successful in achieving consensus opinions. This position reports to the PDA President and CEO.

Duties & Responsibilities:
• Create and execute PDA tactical plans, based on the Strategic Plan, to expand participation by members, to include new science, technology, regulatory and quality opportunities and initiatives, to provide a consistent and strong Pharma/Biopharmaceutical agenda.
• Support relevant PDA Advisory Boards, e.g., Bio Advisory Board (BIOAB), Scientific Advisory Board (SAB) and the Regulatory Affairs and Quality Advisory Board(RAQAB) and all its task forces, and PDA Interest Groups, assuring PDA science documents are completed, published and cited authoritatively on a timely basis.
• Interact effectively with other PDA departments to provide input on science and technology topics, content and speaker identification.
• Direct research projects involving internal and external resources.
• Serve as liaison with other outside organizations regarding Scientific, Regulatory and Quality projects of mutual interest. May assume global leadership of organization’s involvement with selected future Scientific, Regulatory and Quality projects or similar projects.

• BS/BA degree in appropriate science, quality or regulatory major from an accredited university
• PhD degree in appropriate science, quality or regulatory degree preferred
• Successful in consistently achieving the timely publication of scientific and regulatory documents, deliverables and publications
• Successful experience within pharmaceutical or biopharmaceutical manufacturing, quality and or regulatory affairs departments with working experience in global manufacturing, quality and regulatory systems
• FDA, EMA, ICH, PIC/S and/or other worldwide regulatory experience and relationships/contacts
• Successful public speaking
• Successful staff management experience

Location  Mid-Atlantic
Consultant  Phil Ellis

Investigative Writer
Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of Product Discards, Field Actions, or Recalls. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience - 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices. - Good deductive and inductive critical thinking skills required. - Advanced writing skills required. Candidate must possess strong interpersonal, written, and verbal communication skills. Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments. Good knowledge of MS Office programs, including Word and Excel

Location  US
Consultant  Andy Ellis

QA Associate III
This function is responsible for supporting the daily activities related to laboratory operations. Functions include discrepancy review, procedure review, maintenance work order review, qualification/data integrity review, and method transfer/qualification review. This function thresholds events to Team Leaders and Senior Associates when they are outside of the area of responsibility.

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Applies job related skills and understanding of policies and standards in completing tasks.

Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 4 - 5 years’ experience in a Quality Assurance role in the pharmaceutical industry ideally with a background supporting QC functions preferred. Will consider substitution of relevant work experience in an alternate Quality role in lieu of QA requirement.

Location  Midwest
Consultant  Andy Ellis

Senior QA Associate
Job Description:
Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management.

The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks.

- Qualified candidates must have minimum a BS in scientific discipline or equivalent.
- Must have 5-8 years experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms.

Location  Midwest
Consultant  Andy Ellis

Operations Management
Manager, Packaging Development
Manages, directs and sets priorities for a department of skilled packaging engineers to complete packaging related projects to a high standard of excellence and successful conclusion relative to cost, schedule and performance, by applying the most appropriate state of the art packaging technology to enhance continuous improvement and ensure the goals and objectives of the Packaging Development (PkD) department meet and/or exceed department and company functional objectives. Responsible for establishing and directing the Packaging Development department charter and scope of functional objectives, standards, procedures, policies, and goals by working with and supervising other packaging engineers to accomplish a systematic and orderly evaluation, selection and qualification of packaging component materials and designs. Manages overall PkD activities to recommend, design, develop, and qualify product component packaging to support all new product development initiatives and regulatory affairs submission requirements.

• Four year college degree (minimum); preferably in Packaging Engineering or equivalent area or technical training.
• MBA degree is advantageous; but not essential.
• Certified Packaging Engineer desirable, but not required.
• 5-10 years in pharmaceutical or medical diagnostic business required.
• Technical packaging technology knowledge relating to materials, equipment, design, and material specification writing required.
• Good technical writing and verbal communication required. Computer expertise in application programs such as word processing, spreadsheets, relational databases. Project management and power point essential.
• Problem solving and troubleshooting experience.
• Project and people management, and negotiation skills desirable.
• Supervision or management experience.
• Ability to work and manage cooperatively and ability to adapt and handle change required.
• Good judgment and decision skills.

Location  US
Consultant  Andy Ellis

Pharma | Biotech Consultant
Focusing primarily on the pharmaceutical industry, our client company provides for improvement programs, management consulting, project management, R&D support, supply chain planning and training for leading companies worldwide.

The successful candidate for the CONSULTANT opportunity will provide project management leadership and support, participation in lean manufacturing as well as turn around programs with a variety of pharmaceutical clients. This is a unique chance to be part of starting up a new, exciting endeavor for an internationally successful consulting company - an opportunity to gain experience across the breadth of the industry.

We are looking for candidates with strong academic credentials with a BS degree in one of the Engineering, Science or related disciplines as well as a Master's degree in Engineering, Business or Science.

The candidate will either have 1 to 4 years experience in the pharmaceutical or related industry or solid intern assignments during school to accompany the solid academic credentials.

The successful applicant will possess good leadership and interpersonal skills coupled with the ability to work and deliver results in a dynamic and complex environment.

Location  flexible
Consultant  Andy Ellis

Validation & Technology Transfer Manager
Lead the facility, utility, equipment and system & cleaning validation activities for the site and manage validation projects as required. The position is expected to have a solid understanding of industry standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards. Develop and effectively manage technical transfer process and ensure alignment with schedule to meet with corporate goals and metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Production, R&D, Supply Chain and Logistics teams to ensure efficient tech transfer are executed timely and right first time.

• A strong understanding of: Validation concepts, international cGMP regulations, GAMP and other industry standards pertaining to validation, and the technical requirements for Validation and of biopharmaceutical equipment, facilities, and/or instrumentation
• Requires strong understanding of technology transfer, process fit analysis, scale-up/down, process validation and optimization
• Ability to organize and lead staff responsible for tech transferring commercial and clinical biopharmaceutical manufacturing processes
• Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections

Location  NC
Consultant  Tina Nicks

Lead Validation Engineer - Solid Dose
The Lead Validation Engineer is responsible for writing, executing, and reporting validation protocols and other relevant documentation. Other validation lifecycle documentation responsibilities may include User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation, and process validation in support of the equipment, utilities, facilities, products, and processes. The position also requires the use of Risk Assessment tools and the execution of Formal Challenges (Requalifications) and time-based assessments where appropriate. This person will also have responsibilities in the areas of process engineering and improvement, interfacing with Process Development and Manufacturing.

5 - 8 years relevant experience in pharmaceutical validation area with experience in validation of equipment and facilities for manufacture of oral dosage forms .
Consistently demonstrated validation proficiency with advanced knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation.

Location  Midwest
Consultant  Andy Ellis

Research & Development / Clinical Affairs
Principal Scientist
The Principal Scientist is responsible for method transfer/method verification/co-validation of compendial and non-compendial analytical methods utilized across Fresenius Kabi according to written procedures. The testing of routine and non-routine samples where specialized training is essential. Planning and coordination of method transfer/method verification activities in the transfer of analytical methods from the Product Development department or between Fresenius Kabi facilities. Providing technical support to all testing laboratories within Fresenius Kabi as well as leadership and technical expertise in projects where troubleshooting of analytical methods and instrumentation is required. The position also requires a broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements. The Principal Scientist reports directly to the Manager, Technical Services and may supervise two or three people with levels 15 and below. The Principal Scientist works closely with Product Development and QC Chemistry.

• BS with 3-5 years of related experience. • Extensive knowledge of analytical chemistry as well as concepts in developing and validating methods to correct pharmaceutical standards. • Extensive knowledge of parenteral formulations. • Strong knowledge of GMP’s, GLP, ICH, and USP guidance and regulations. • Prepare documentation for Regulatory Submissions as required. • Able to review/approve/update documentation such as protocols, test methods, SOPs, specifications, ANDA submissions, etc. • Strong analytical and problem solving skills. • Strong interpersonal skills and highly effective in team settings. • Strong project management skills, written, and oral communication skills. • Able to travel 25%

Location  Northeast
Consultant  Andy Ellis

HVAC Engineer
Position Summary:
The HVAC Engineer\Specialist is intended to be the subject matter expert for HVAC and associated utilities at the site. This position is responsible for data gathering, design, estimating, proposal and implementation of HVAC, refrigeration and ultra-cold refrigeration systems projects. Installs, maintains, troubleshoots and repairs all facilities HVAC systems including compressors, chillers, air handling units, HEPA filtration, and related equipment. Capable of troubleshooting and repairing boilers and associated equipment. Installs, maintains, troubleshoots and repairs all coolers, freezers, refrigerators and incubators. In addition to the above tasks, it will be the responsibility of this position to plan, execute and continuously improve the preventative maintenance related to the facility’s HVAC system in general.

• Bachelor’s degree in Engineering or related field and 5-10 years of experience in a FDA regulated industry or an equivalent combination of education and experience.
• 5-10 years hands-on experience with HVAC and Utilities systems and deep understanding of the principles of HVAC in general.
• Able to develop, drive and implement improvements to increase reliability and performance of HVAC and related systems.
• Knowledge and understanding of validation principles, protocols and application for equipment and processes.
• Ability to understand, and work with, regulatory requirements such as CFR’s, GMP, FDA, OSHA.
• Knowledge and hands-on experience with pharmaceutical direct and indirect utility systems, equipment and facilities.
• Knowledge of cGMPs in Pharmaceutical manufacturing with a high quality mind set.

Location  NC
Consultant  Tina Nicks

Manager, Engineering
Leads the Site Engineering team. Responsible for managing engineering functions including plant engineering, project management, and computer aided drawing and design. Responsible for the design, procurement, installation, and improvement of site manufacturing and utility equipment as well as facility upgrades and expansions in a cGMP environment. Responsible for the design, fabrication/construction, and implementation of upgrades to existing and/or new facilities, utilities, and equipment. Directly manages Manufacturing and Project Engineers, CAD personnel, Technical Writers, Mechanics/Electricians, Administrative staff, and interns to meet all regulatory and Company specific policy requirements and to improve plant quality, operational efficiency/effectiveness, capacity, capability, and modernization objectives.

Knowledge of all aspects of manufacturing processes, automation and controls such as PLCs and HMls, machine design and layout, utilities and piping including compressed air and gasses, steam and water systems, HVAC, fire protection, project management, Autocad, construction, drawing standards including the ability to read and decipher drawings including process and instrumentation (P&ID), and general supervision.
BS in an Engineering/technical discipline required, masters preferred. MBA a plus.
Minimum 5 years of experience in an engineering and/or manufacturing setting, cGMP / Pharmaceutical environment preferred.

Location  Northeast
Consultant  Andy Ellis

Technology Transfer Leader
The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and I&D teams. The position is responsible for assisting with and/or coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumbent is also responsible for designing manufacturing processes of varying degrees of difficulty for new or modified products to ensure robust and reliable product design and manufacturing processes for commercial scale. This position plans, coordinates, and oversees the product life cycle which includes development, stability, product validation batches, and cleaning validation/verification studies. The incumbent will provide necessary leadership to organize project teams, define milestones, support gap analysis and assist in qualification and validation activities.

Coordinate the transfer and implementation of projects and technology from development groups to the plant manufacturing site. Design manufacturing procedures for complex new or modified products. Plan, coordinate, and oversee the manufacture of development, stability, product validation batches, and cleaning validation/verification studies. Review technical documents to ensure alignment with Current Good Manufacturing Practices ("cGMP") and regulations. Develop and provide technical support to manufacturing operations and regulatory submissions.

Education and Experience:
Bachelor’s degree or foreign education equivalent in Chemistry, Biology, Biochemistry, or Engineering and three (3) years of experience implementing product and process development projects within a pharmaceutical manufacturing environment.

Location  US
Consultant  Andy Ellis

Process Engineer
Job Description:
Seeking an experienced Process Engineer to join our team. This position will provide support and assistance in the manufacture of pharmaceutical products for commercial and clinical supplies. Key duties include: scale-up and transfer of oral solid dosage formulations/processes to production facility, design and recommend equipment purchases, write and execute equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability.

Bachelor's degree; scientific discipline including Engineering or equivalent field. Minimum of 2+ years working experience in oral solid dose pharmaceutical engineering experience or 5+ years pharmaceutical engineering experience.

Technical Knowledge/Skills Needed:
*Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
*Thorough knowledge of automated control systems.
*Thorough knowledge of computer systems operation and software.
*Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
*Thorough knowledge of chemistry, statistics, equipment design, process control and process scale-up.
*Knowledge of oral solid dose pharmaceutical operations and equipment validations.
*"Hands-on" ability to install and troubleshoot instrumentation and equipment.
*Ability to troubleshoot and maintain manufacturing systems, equipment and processes.
*Ability to author high quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications and SOPs.
*Ability to specify and size manufacturing systems, equipment and process equipment.
*Ability to gown for clean room operations.
*Ability to read, understand and accurately follow company SOPs and guidelines.

Location  Midwest
Consultant  John Lee

Senior Engineer - Process Development
The key duties of this role are to be the technical leader in late stage small molecule scale-up. The role will be responsible commercial start-up efforts as well as providing support for investigations and identifying process optimization opportunities within commercial operations.

This role is expected to have a strong lab/pilot plant presence: design and execute statistical studies with a focus on process understanding & robustness, interpret and present data, participate in cross-functional development teams, and author technical reports.
Provide technical leadership for start-up of new commercial process lines.
Utilize theoretical and practical expertise to troubleshoot and resolve technical issues with experimental studies or commercial operations.
Identify and implement process improvements into on-going commercial operations with emphasis on yield improvement and reducing process variability.
Generate documentation to support process design and implementation activities within a cGMP environment.
Support FDA pre-approval and post-approval inspections by serving as technical expert for development and processing operations.
Present, where appropriate, technical data to internal or external audit groups and commercial partners.
Build strong relationships with internal and external stakeholders and take advantage of these relationships to identify new opportunities.
Ensure all company and departmental policies and procedures are adhered to and follow cGMPs/cGLPs.

PhD in Chemical/Mechanical Engineering and 5+ years of experience or MS degree and 10+ years of experience. Significant experience in development through GMP commercial batch manufacture, and scale-up/optimization of pharmaceutical products is required.

Minimum 5 years of experience in process development, process engineering or related commercial scale-up/manufacturing in the pharmaceutical industry
Experience in leading/executing product development programs for early phase development through commercial validation/launch
Experience in technology transfer of process to commercial facilities
Demonstrated technical expertise for developing new and existing technology based pharmaceutical processes, ensuring a high level of technological competency
Experience in a Process Development environment using PAT and a fundamental understanding of Quality by Design methodology in developing GMP processes Sterile and/or aseptic processing experience preferred but not required

Location  Midwest
Consultant  Tina Nicks

Process Engineer
Qualified candidates will provide process engineering support and expertise to Engineering, Production, Laboratory, Validation, Automation and Maintenance to support sterile manufacturing processes improvements and projects. This includes but is not limited to:


  • Provide assistance for technical transfers from laboratory to full scale manufacturing.
  • Modifications to existing processes or adding new processes that will improve process safety, reduce plant operational costs and product quality.
  • Provide expertise in diagnosing and correcting major operational problems and evaluate equipment process and automation sequences for proper control and compliance within specification.
  • Support customer bid proposals and develop process flow diagrams, identify process, facility and safety gaps with cost effective technical solutions. Develop cost estimate, implementation timing with assumptions, and alternatives to be considered.
  • Specify, purchase and manage the installation of sterile process equipment.
  • Prepare process flow sheets, energy balances, equipment specifications, material balances, etc. to provide sufficient information for Project Engineering in all aspects of project delivery.
  • Provide daily process engineering support to Production on operating problems and to maintenance/plant engineering on equipment performance and materials problems.
  • Provide technical recommendations to permit plant operation within state & federal requirements.

-Must have a B.S. degree in Engineering and 4 years experience in the Pharma environment.
-Must have experience in a sterile product manufacturing environment.


Location  North Carolina
Consultant  John Lee

Regulatory Affairs
Regulatory Specialist
Key member of the BioMedical product team to ensure continued regulatory compliance for all products. Works with Engineering and 3rd party test labs to ensure completion of product testing required for global approvals and license. Coordinates the assimilation of documentation required for global product approvals/license including U.S. 510K’s, EU MDD certifications, Health Canada License, China FDA license, and other approvals as required.

Job Summary
• Ensure product/process compliance with the requirements of ISO 13485, FDA QSR, MDD, TPED, CMDCAS, etc.
• Lead the initial effort to secure the required product approvals including document submissions to regulatory authorities and notified bodies.
• Proactively maintain existing approvals including submission of renewal paperwork.
• Work with Engineering on new product releases and changes to develop Regulatory Plans including required testing, approvals, labeling and post market reporting.
• Work with Engineering to develop and maintain MDD, TPED and PED technical files.
• Work with Design and Development Project teams to ensure compliance with Design Control Requirements.
• Assist with training in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding regulatory and associated reporting requirements.

Education & Experience
• Experience with various Codes and Standards (ISO 13485, FDA, QSR, MDD, CMDCAS, etc.) required.
• Working knowledge of ISO 13485:2016 and MDSAP a plus.
• Experience with U.S. FDA 510K submittals.
• Experience and working knowledge with international product approvals.
• Good communication skills at all levels (written and verbal)
• Proven ability to work with cross-functional teams and in a project management environment
• Demonstrated ability to plan and manage multiple tasks/projects
BS degree required, preferably an engineering or technical degree.

Location  Southeast
Consultant  Phil Ellis

Sales, Marketing, Finance, and IT
Associate Director, Process Automation
This position provides leadership to the Process Automation team in the IT Department engaged in the development and maintenance of the Automation Systems used in the production of drug products. The position collaborates with global business and IT colleagues to ensure long-term plans are established and implemented to ensure a robust and sustainable Process Automation program that is aligned with the strategic goals of the company.

o Set direction for the design, implementation and support for Plant-Wide Process Automation (PA) and Supervisory Control and Data Acquisition (SCADA) solutions within the facility used to support pharmaceutical development and manufacturing.
o Interpret business requirements, anticipate opportunities and influence cross-functional decisions. Create and align strategic direction for Process Automation both on site and globally where practical.
o Leads, directs and motivates the Process Automation Team in the IT Department, ensuring that the structure, skills and competencies required adapt with business needs. Creates and maintains an environment where team members are clear on expectations, developed to reach higher potential, given the right tools and support, feel empowered for delivery and held accountable.
o Align and prioritize IT Process Automation projects, resources and support activities with other site organizations and projects including Engineering, Maintenance, Operations, Quality Assurance, Validation, and QA Ops.
o Ensure procedures, processes and SOP’s are established and maintained for the design, development, validation and support of solutions. Develop and maintain lean and efficient ways of working, policies/guidelines and procedures for the team ensuring consistency and quality.
o Ensure that the systems and solutions supported are fit for purpose and seek opportunities to improve.
o Ensure solutions are compliant with regulatory requirements.
o Drive innovation by engaging ideas from the industry, academia and business peers. Share knowledge with Business and IT colleagues to develop long-term solutions.
o Fosters collaborative relationships within and across groups and uses effective influencing and negotiation skills with senior level management and key stakeholders.
o Lead by example and encourage followership. Promote continuous improvement and act as a change agent to drive business improvements.

o Degree in Computer Science, Information Systems, Automation or other related field or equivalent work experience.
o 10+ years process automation and/or engineering experience including extensive knowledge and expertise in project/program management, Process Automation applications and lifecycle management.
o 5+ year Management experience.
o Previous experience in the biotechnology / pharmaceutical industries and GXP Computerised Systems
o Strong communication and presentation skills.
o Effective risk analysis and stakeholder facilitation to reach timely decisions.
o Strong conflict management and prioritization skills.

Location  US
Consultant  Phil Ellis