Careers

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At Summit Biosciences, we aim to provide and promote an environment of continuous learning and improvement, which leads to and harnesses innovation. We aspire to lead our industry in the quality of work that we perform and in our compliance with regulations while at the same time finding and applying innovative ways to manage risk in all areas.

If you're a motivated and passionate professional looking to make a difference in the field of pharmaceuticals, we would like to learn more about you.

Mail

Human Resources
Summit Biosciences, Inc.
1513 Bull Lea Rd
Lexington, KY 40511

Fax

859-254-0137
Attention: Recruiting Manager
Human Resources

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Summary:

This individual is responsible for performing routine tasks in the QC laboratory under direct supervision.

Essential Duties:

  • Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing.
  • Maintain the laboratory in accordance with SOPs.
  • Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.
  • Revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.
  • Develop Understanding of basic analytical techniques such as:
  • HPLC
  • UV/Vis
  • FTIR
  • GC
  • Nasal Spray testing
  • Develop understanding of cGMPs.
  • Develop oral and written communication skills.
  • Recommend and implement as required, innovative approaches to problem solving.
  • Other duties as assigned.

Knowledge, skills & abilities:

  • Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
  • Team player with well-developed interpersonal, organizational, and communication skills.
  • Maintains proper social etiquette and self-control when dealing with stressful situations.

Qualifications:

  • Bachelor’s/Masters degree in Chemistry, Biology, or related field
  • 0-3 years of relevant experience in an FDA regulated cGMP environment
  • Qualified to work with controlled substances

Summary:

Summit Biosciences Inc. is currently looking for a Technical Recruiter to join our close-knit, energetic team in Lexington, KY. If you are highly motivated with previous experience in recruiting and/or pharmaceuticals this could be the position for you!

Essential Functions:

  • Full Life-Cycle recruiting of Clinical, Scientific, and Pharmaceutical professionals.
  • Partners with HR and/or hiring managers to determine staffing needs.
  • Build a network of candidates utilizing various resources.
  • Come up with creative strategies to recruit active and passive candidates.
  • Establishing, building and maintaining relationships with both clients and candidates to ensure achievement of staffing goals.

Qualifications:

  • BA/BS Degree
  • At least 3 years of prior recruiting or relevant experience
  • Excellent communication and presentation skills
  • Proven success working in a fast paced
  • Understanding of current Good Manufacturing Practices (cGMPs)
  • SHRM or HRCI certification credentials preferred

Summary:

The ideal candidate will partner with the engineering team to develop executable projects for key capital expenditures, equipment or facilities.  The job requirements will include the development of project plans, schedules, action items, budgets and tracking completion of activities.  The role will support the development and execution of the Summit Capital Plan.

Essential Duties:

  • Responsible for Scope, Schedule, and Budget on multiple concurrent capital projects
  • Develops scopes for project funding
  • Maintains Capital Expenditure list and on-going Capital Planning
  • Leads design reviews on capital projects
  • Leads project teams in partnership with engineering and ensures timely project action items and planning is executed
  • Sets validation strategy in coordination with Validation Engineering team
  • Develops/coordinates RFQ documentation for equipment, services, and facilities
  • Assure compliance with quality policies and procedures related to project execution activities
  • Review and approval of technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents
  • Lead risk assessment exercises related to equipment and processes (FMEA, VSM, etc)
  • Basic understanding of controls technology and related regulations
  • Other duties as assigned

Qualifications:

  • BS in Engineering or related science or equivalent experience
  • 5+ years in a cGMP manufacturing environment. Project management experience is a plus.
  • Excellent working knowledge of cGMPs and regulatory requirements is preferred
  • Excellent technical writing and organizational skills
  • Excellent organization and planning skills
  • Strong communication and interpersonal skills
  • Ability to change priorities in response to company demands while continuing to deliver results
  • Strong work ethic; ability to excel in a fast paced, multiproduct environment
  • Demonstrated ability to work/collaborate within teams while interfacing with both internal and external colleagues
  • Knowledge of software including:  Microsoft Office including MS Project

Job Summary

The Maintenance and Reliability Engineer position is responsible for establishing new and improving existing systems as they relate to Production Maintenance. The position will help Summit Biosciences to continue along the maintenance maturity continuum to achieve excellence as defined by best industry practices. The position will be responsible for establishing optimum work processes, administrative controls and deployment to the key functions.

The Maintenance and Reliability Engineer will work with the Project Engineers, Process Engineers, Process/Facilities Mechanics and Operations personnel to make sure that all equipment is designed and managed for maximum utility and Total Cost of Ownership.

The Maintenance and Reliability Engineer is a "hands on" role. This position will support the Director of Engineering function and serves as the key technical resource for the manufacturing operation focusing on preventative maintenance, troubleshooting and problem resolution for electronic/mechanical equipment issues. This position also plays a key role in continuous improvement and performance excellence. This position will work alongside and support Process/Facilities Mechanics as needed.

Responsibilities and Duties

  • Provides maintenance support to all aspects of the manufacturing process in accordance with cGMP guidelines, current Good Manufacturing Practices (cGMP), and all internal operating procedures.
  • Improves the performance of production lines by using effective preventative maintenance, timely problem solving, equipment improvements, and training of production/maintenance personnel as needed.
  • Develop and/or improve current methodologies and work practices as they relate to Preventative and Predictive Maintenance.
  • Review data and information using basic statistical tools to transition time-based maintenance into frequency-based maintenance and/or Reliability Centered Maintenance
  • Implements measures to baseline maintenance performance and then improvement targets as they relate to cost, quality, downtime, etc.
  • Utilize and improve the equipment risk assessment techniques so that prioritization can be given to all resources and how they are managed
  • Focus on safe, efficient, reliable maintenance and operation of equipment to ensure the production of quality products.
  • Use metrics to help drive business decisions on asset replacement versus useful life extension evaluations.
  • Provide electronics troubleshooting and repair: AC and DC Drives; PLC Troubleshooting supporting Automation & Instrumentation department.
  • Support and coordinates outside services when needed to support the efforts of the mechanics.
  • Provides support to the maintenance department to maintain a culture of collaboration, continuous improvement, safety, and strives to develop a high-performing maintenance team.
  • Work with Project Engineers, Process Engineers, Process/Facilities Mechanics to establish a spare parts inventory that optimizes the business needs of the plant with cost outlay.
  • Helps support evaluation of ongoing service contracts.
  • Supports or Leads projects as needed.
  • Actively participates in all Environmental, Health, and Safety aspects of the plant and ensures all safety procedures and programs are effectively being followed.
  • Promotes knowledge and implementation of 5S, TPM, SMED, and other lean/six sigma/continuous improvement tools.
  • Work with Process/Project Engineers to implement standard methods for work instructions, return to service protocols and equipment risk profiles.
  • Add engineering knowledge and experience on equipment during the design phase.
  • Work with vendors to source parts and to substitute OEM parts with more economical options, designing and testing improved parts, updating older electronics that are no longer supported by manufacturers to improve equipment functionality.
  • Meets local, state, and federal regulatory requirements relevant to Production lines and Engineering areas of responsibilities.
  • Other duties as assigned

Qualifications and Skills

  • BS in an Engineering Field (preferably Mechanical, Electrical, or Chemical)
  • 5 to 7 years of experience working with electrical, electronic and mechanical maintenance
  • Pharmaceutical maintenance/reliability experience in a Manufacturing Plant environment and TPM experience.
  • Excellent working knowledge of cGMPs and regulatory requirements is preferred
  • Excellent communication skills, organizational skills, computer skills.
  • Excellent communication skills, organizational skills, computer skills.
  • Must be a change agent.
  • Strong analytical and problem solving skills.
  • Ability to work in/with cross-functional teams.
  • Strong coaching, facilitation, and presentation skills.
  • Ability to collaborate with other support groups.
  • Experience in understanding and troubleshooting mechanical systems, process controls, PLC infrastructure (Allen-Bradley preferred), and calibration systems a plus.
  • Six Sigma Training is a plus.
  • Statistical training and demonstrated usage is a plus.
  • Ability to solve problems via advanced technical knowledge, complex analysis and theory testing.
  • A record of success in implementing lean manufacturing concepts for continuous improvement.
  • Strong attention to detail and skillful in handling small parts.
  • Experience with spending most of the time on the manufacturing floor. This is not a coordinate from the office position.
  • Ability to change priorities in response to company demands while continuing to deliver results
  • Strong work ethic; ability to excel in a fast paced, multiproduct environment

Job Type: Full-time

Required experience:

  • electrical, electronic and mechanical maintenance: 5 years

Required education:

  • Bachelor's

Summary:

The Process Development Engineer is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment. These activities include designing and leading studies to support process development. Writing/executing/summarizing protocols for testing equipment, product and processes. Also assists in troubleshooting, equipment and facility design, and managing commissioning, validation and revalidation projects.

Essential Duties:

  • Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing processes for the manufacture of nasal spray drug products
  • Engage with the Pharmaceutical Development Group in all stages of product/process development to facilitate successful transfer of activities to the commercial manufacturing environment
  • Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements
  • Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments
  • Participate in the development and implementation of procedural or automation improvement changes
  • Write procedures, protocols and reports for manufacturing, utility, lab equipment, cleaning and process validation
  • Compile validation packages and assure all required documentation is accurate and complete
  • Champion process improvement projects and ensure equipment and systems remain in a qualified state
  • Lead investigations and assure thoroughness of investigation, identification of root cause, documentation and closure
  • Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
  • Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA’s through participation on cross functional teams
  • Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).
  • Train technicians on Production Batch Records.
  • Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA).
  • Other duties as assigned

Qualifications:

  • BS in Chemical Engineering or related life science
  • Minimum of 2-5 years of previous work experience in a related or unrelated field.
  • Experience providing technical support in a cGMP manufacturing environment including hands-on product development, optimization and troubleshooting of equipment and processes is preferred
  • Excellent working knowledge of cGMPs and regulatory requirements is preferred
  • Excellent technical writing and organizational skills; extremely detail oriented
  • Good mechanical aptitude
  • Good interpersonal skills and the ability to work well in a team environment
  • Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment
  • Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.
  • Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements
  • Strong listening, writing, reading, and verbal communication skills

Summary:

Responsible for developing new procedures, executing microbiological method validations, conducting investigations, finding root causes, writing technical reports, assisting on environmental monitoring (EM), and performing microbiological tests of components, raw materials, in-process, stability and finished product samples.

Person Attributes:

  • Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
  • Team player with well-developed interpersonal, organizational, and communication skills.
  • Maintains proper social etiquette and self-control when dealing with stressful situations.
  • Three or more years of hands-on experience developing and validating microbiological methods per USP and EP to include MET/TSM, Bile Tolerant Gram-Negative Bacteria, BCC, Antimicrobial Effectiveness Tests and Particulate Matter Analysis via

Responsibilities and Essential Skills:

  • Review and approve laboratory data.
  • Develop microbiological methods.
  • Write protocols and execute microbiological method validations.
  • Conduct investigations, determine root cause and applicable CAPAs.
  • Lead microbiological related projects to implement new methodologies.
  • Participate in the validation of plant systems and manufacturing processes.
  • Participate on drug product development teams.
  • Train personnel in microbiological methods.
  • Demonstrated knowledge of pharmaceutical microbiology techniques.
  • Perform trend analysis of EM results.
  • Working knowledge of current Good Manufacturing Practices (cGMPs)
  • Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.
  • Perform routine and batch EM.
  • Perform incoming raw material and component testing, in-process analyses, finished product release testing and stability testing.
  • Maintain the laboratory in accordance with SOPs.
  • Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.
  • Other duties as assigned.

Qualifications:

  • Bachelors degree in Microbiology, Biology or related field with at five years of relevant experience in an FDA regulated cGMP environment
  • Masters degree with at least three years of relevant experience; or Ph.D.

Summary:

Responsible for assisting with the operations of the QC Microbiology Laboratory including environmental monitoring, raw material, component, in-process and finished product release, stability testing, assisting in method validations, instrument maintenance, document generation and review, and other duties as assigned.

Essential Duties:

  • Perform environmental monitoring of cleanrooms, purified water, and other systems.
  • Perform incoming raw material, component, in-process, finished product release and stability testing.
  • Assist in maintaining the laboratory in accordance with SOPs, cGMPs, OSHA and FDA regulations.
  • Assist in the trending of environmental monitoring data.
  • Calibrate, operate and maintain laboratory instrumentation for product testing, including routine preventive maintenance and troubleshooting.
  • Write, revise and review Standard Operating Procedures and Forms.
  • Review and approve laboratory data.
  • Assist in conducting and documenting laboratory investigations.
  • Maintain supplies inventory
  • Coordinate instrumentation maintenance and repair work.
  • Other duties as assigned.

Qualifications:

  • Bachelors degree in Microbiology, Biology or related field
  • Experience performing laboratory analyses is preferred
  • Good technical writing and organizational skills
  • Capable of adjusting priorities in response to changing conditions and schedule
  • Experience with Microsoft Office programs
  • Good interpersonal skills
  • Ability to work well in a team environment

Summary:

Responsible for providing quality involvement and oversight during pharmaceutical development and manufacturing, particularly related to the design and qualification of new equipment. Observe critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.

Essential Duties:

  • Supports the development and maintenance of Quality Systems as appropriate.
  • Leads continuous improvement objectives to assure compliance with DEA, FDA, and EMA regulations.
  • Advises senior management on findings and recommendations related to quality issues.
  • Assists with the CAPA and Change Control Systems.
  • Reviews, and approves cGMP documentation including procedures, validation protocols, development reports, and other related documents.
  • Develops and maintains metrics and trending reports for Compliance-related activities.
  • Assists in product complaint investigations.
  • Performs activities associated with various one-time or on-going projects.
  • Collaborates with departments and external suppliers regarding quality concerns.
  • Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
  • Supports regulatory inspections and customer audits.
  • Assists Manager with daily and project activities as needed.
  • Other duties as assigned.

Qualifications:

  • Bachelor degree in a scientific discipline
  • At least 5 years cGMP experience, with at least 2 years in an engineering or quality assurance role.
  • Ability to assess problems, to identify solutions, to plan and implement necessary changes
  • Knowledge of cGMP regulations and validation principles
  • Ability to work well in a team oriented environment
  • Well-developed communication and technical writing skills
  • Qualified to work with controlled substances

Summary: 

In this hands-on position, the Scientist will develop analytical methods for quality control and characterization of products, perform drug product formulation development projects, participate or lead drug product development programs or projects and provide analytical and technical support for process development and manufacturing.

Responsibilities include developing appropriate quality measures for Summit Biosciences’ products; developing, validating, transferring or verifying analytical methods, characterizing products and processes, training and creation of documentation.

Essential Functions:

  • Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development
  • Responsible for multi-department and multi-site communications required to facilitate new product development
  • Lead or participate on product development teams
  • Prioritizes workload to ensure that key objectives are met on time and to budget
  • Perform method development, assay validation and characterization for multiple projects
  • Conducts experiments including design of experiments (DoE)
  • Conducts technical projects with the appropriate use of company resources in mind
  • Makes recommendations for continuous improvement projects that improve effectiveness
  • Perform nasal spray drug product formulation development projects
  • Perform data reviews, prepare reports and quality documents
  • Identify and implement new techniques and instrumentation to expand internal capabilities
  • Author technical reports, regulatory submissions, SOPs, validation protocols, batch records and other cGMP documents
  • May supervise the work of, and train, junior staff

 Knowledge, Skills and Abilities:

  • Extensive technical experience in analysis and development of pharmaceuticals
  • Comprehensive understanding of small molecule chemistry
  • Demonstrated knowledge of modern analytical techniques, including HPLC. Knowledge of nasal spray characterization a plus.
  • Experience in development and validation of methods destined for QC in the pharmaceutical industry
  • Understanding of current Good Manufacturing Practices (cGMPs)
  • Proven team player with well-developed interpersonal and mentoring skills, excellent organizational skills, communication skills, including written documentation skills and presentation skills

 Minimum Qualifications:

  • Degree in Chemistry or related field; advanced degree preferred
  • 5 years experience in analytical and drug product development activities regulated by FDA
  • Outstanding capabilities for adjusting priorities in response to changing conditions and schedules
  • Experience with nasal spray drug product development and characterization is a plus

 Success Factors:

  • Enthusiasm for building a company
  • Enthusiasm for working in teams and collaborating with both internal and external colleagues
  • Substantial expertise in small molecule chemistry
  • Interest in applying new technologies
  • Ability to use resources to tenaciously resolve problems and close projects

In this hands-on position, the Sr. Scientist will develop analytical methods for quality control and characterization of products, lead drug product formulation development projects, lead drug product development programs and provide analytical and technical support for process development and manufacturing.

Responsibilities include developing appropriate quality measures for Summit Biosciences’ products; developing, validating, transferring or verifying analytical methods, characterizing products and processes, training and creation of documentation.

Essential Functions:

  • Provide expertise in chemistry and analytics related to Summits’ products
  • Perform method development, assay validation and characterization for multiple projects
  • Manage and participate on project teams
  • Lead nasal spray drug product formulation development projects
  • Perform data reviews, prepare reports and quality documents
  • Prepare analytical sections of regulatory filings
  • Identify and implement new techniques and instrumentation to expand internal capabilities
  • Author technical reports, regulatory submissions, SOPs, validation protocols, batch records and other cGMP documents

Knowledge, Skills and Abilities:

  • Extensive technical experience in analysis and development of pharmaceuticals
  • Comprehensive understanding of small molecule chemistry
  • Demonstrated knowledge of modern analytical techniques, including HPLC. Knowledge of nasal spray characterization a plus.
  • Experience in development and validation of methods destined for QC in the pharmaceutical industry
  • Understanding of current Good Manufacturing Practices (cGMPs)
  • Proven team player with well-developed interpersonal and mentoring skills, excellent organizational skills, communication skills, including written documentation skills and presentation skills

 Minimum Qualifications:

  • Degree in Chemistry or related field; advanced degree preferred
  • 7 years experience in analytical and drug product development activities regulated by FDA
  • Outstanding capabilities for adjusting priorities in response to changing conditions and schedules
  • Experience with nasal spray drug product development and characterization is a plus

Job Description

Summary:

Responsible for cleaning, sanitizing, operating and maintaining process equipment used during the manufacture of sterile nasal spray drug products and for completing the associated documentation. Duties also include cleaning, organizing and monitoring manufacturing cleanrooms.

Essential Duties:

  • Follow Production Batch Records (PBRs) to operate, monitor and control equipment and process parameters during manufacture.
  • Follow SOPs to clean, sanitize and prepare process equipment for manufacturing. Follow SOPs to clean and sanitize rooms as required.
  • Complete PBRs, Log Books, Forms and other documentation. Assist in compilation and review of lot records prior to submitting to QA.
  • Write and revise SOPs and Forms to accurately reflect the current procedures.
  • Maintain assigned manufacturing area neat, clean and well stocked with supplies
  • Assist with the training of other manufacturing team members.
  • Coordinate manufacturing, calibration and maintenance activities with other departments.
  • Assist with the writing, execution, and review of validation protocols for manufacturing/support equipment.
  • Independently champion manufacturing or facility related improvement projects.
  • Participate in the performance routine preventive maintenance on facilities and equipment.
  • Help identify continuous improvement and cost savings opportunities.
  • Adhere to cGMPs, SOPs, and Safety policies.
  • Other duties as assigned.

Candidate Attributes:

  • Excellent organizational skills and attention to detail.
  • Strong interpersonal and communication skills.
  • Motivated to perform work while maintaining a focus on the long-term learning and self improvement.
  • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
  • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
  • Good written communication skills to read and write SOPs and complete documents.
  • Pharmaceutical experience is preferred.
  • Experienced with Microsoft Word and Excel.

Qualifications:

  • BS in a scientific discipline or equivalent experience.
  • 0 - 5 years of applicable experience working in a pharmaceutical manufacturing environment.
  • Experience with sterilization processes or aseptic technique preferred.
  • Good written communication skills to write SOPs and other cGMP documents.
  • Qualified to work with controlled substances.
  • Strong interpersonal skills and the ability to work well in a team environment.
  • Qualified to work with controlled substances.

Summary:

The IT Manager will be responsible for maintaining and expanding our computer networks in a cost-effective way to meet future needs. He/She will be responsible for developing network maintenance and growth plans, creating annual and project budgets, managing the IT staff and keeping the executive team up to date on the latest networking technologies that could help the company to succeed. .

Essential Duties:

  • Manage IT’s operations and projects, such as:
  • Oversee network architecture, including wireless management, switches, firewalls, routers and virtual servers.
  • Ensure the security of the IT infrastructure.
  • Develop and implement policies and procedures related to data acquisition, support, security, and backup.
  • Coordinate with other departments to develop solutions consistent with the company’s objectives.
  • Develop and implement disaster recover procedures.
  • Directs and sets departmental priorities for IT staff. * Manage all stages of the IT projects assigned with minimal support, including planning, implementing and monitoring activities.
  • Provide appropriate business analysis by working closely with business and IT areas to understand the need and work with IT to identify alternative technical, architectural and design solutions to meet that need. Identify future business needs, especially from a strategic perspective.
  • Manage and participate in IT’s response to issues and alerts.
  • Maintain and evaluate hardware needs and supplies.
  • Manage the development and acquisition of new technologies and tools to improve the organization’s internal operations and data delivery.
  • Monitor and track project progress and performance against project plans. Report status to project stakeholders through structured communication (written status reports, steering committee meetings, documents, etc.) as well as informal approaches (ad hoc requests and emails).
  • Conduct user training and other change management activities to achieve system adoption within areas impacted by new features and complete solutions.
  • Oversee the database systems to optimize their use and functionality while ensuring the integrity of systems and data.
  • Manage relationships and coordinate with external consultants and vendors regarding hardware, software, implementation and system expertise.
  • Manages GMP and internal documentation of SOP’s, forms, and other related IT documents.

Knowledge, skills and abilities:

The individual must have “hands on” experience in an enterprise “start-up” corporate environment. Specific qualifications desired include:

  • Strong experience with supporting a primarily Windows Environment (Windows Server 2003/2008/2012 and Windows XP/7/10 workstations)
  • Some experience with Linux (Ubuntu/CentOS)
  • Strong experience with Database systems (MSSQL, MYSQL, Oracle, etc.)
  • Strong experience with virtualization (VMware ESXi)
  • Strong experience with enterprise grade firewalls, switches, and access points
  • Strong experience with security audited environments
  • High level of confidentiality
  • Strong organizational skills to help maintain current IT projects and progress
  • Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
  • Ability to work with minimal supervision
  • Strong work ethic and an ability to excel within a rapidly changing and growing environment
  • Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
  • Capable of multi-tasking on multiple IT requests and business priorities at the same time.
  • Pharmaceutical and scientific knowledge is desired.

Minimum Qualifications:

  • Bachelor’s degree in computer science, information systems or related field.
  • 4+ years in an IT leadership role
  • 5-7 years IT experience in enterprise and server environments, preferably in a FDA regulated cGMP facility
  • Network +, Security +, CCNA, MCSA or MCSE Certification
  • Experience with ERP implementation, such as SageX3

Summary:

Responsible for assisting in the management of the facility cGMP documentation systems including FDA/EU regulatory documentation. This includes all activities related to the development, approval, distribution, archiving and revision of Standard Operating Procedures (SOPs), Production Lot Records, Validation Protocols, Forms, FDA submissions and correspondence, logbooks and other cGMP documents. Also responsible for assisting in the management of the documentation related to change control, personnel training and for providing general administrative support to all functional groups.

Essential Duties:

  • Maintain all cGMP documents in a controlled, up-to-date, secure manner in compliance with all established procedures and FDA regulations.
  • Write and revise SOPs, forms and other documents to continually improve cGMP compliance.
  • Provide general administrative support as required.
  • Assist in developing and managing documentation related to the change control and change tracking system.
  • Assist in developing and managing the plant-wide training system and training database.
  • Other duties as assigned.

Qualifications:

  • Bachelor’s degree preferred
  • 2 years administrative/office work experience
  • Excellent organizational and interpersonal skills
  • Excellent writing skills
  • Detail oriented
  • Computer literate in MS Word
  • Pharmaceutical or cGMP documentation experience preferred
  • Ability to work well in a team environment
  • Qualified to work with controlled substances

Summary:

Assist with the day to day operations of the QC laboratory.

Essential Duties:

  • Maintain the laboratory in accordance with SOPs, cGMPs, OSHA and FDA regulations. This may include, but is not limited to washing laboratory glassware, performing safety inspections, cleaning hoods, and disinfecting benches.
  • Receive ordered materials, label and store appropriately.
  • Prepare supplies for autoclaving.
  • Perform bi-weekly sweeping and mopping of the laboratory floors.
  • Account for lab coats and arrange cleaning as required.
  • Maintain supplies inventory and generate purchase requisitions for replacement materials as needed.
  • Perform daily checking and weekly changing of charts.
  • Data package pagination and filing.
  • Other duties as assigned.

Qualifications:

  • High school diploma or GED
  • Good organizational skills
  • Experience with Microsoft Office programs is preferred
  • Good interpersonal skills
  • Ability to work well in a team environment