Careers

Join Our Team

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

Browse through our available positions

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

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: 

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

Summary:

The Manager is responsible for the overall operation of the Information Technology department including implementation of electronic systems to help streamline work, reduce costs and maintain quality.  This position is responsible for leading a team to identify, implement and manage computer systems for all functional areas in an FDA regulated pharmaceutical manufacturing organization.

Essential Duties: 

  • Manage the day-to-day operations of the Information Systems department in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA, EU, and DEA regulations
  • Lead the evaluation of new electronic systems to identify total cost of ownership and benefits
  • Write SOPs, programs, and protocols necessary for operations
  • Lead validation activities related to computerized systems and contribute as a member to the manufacturing plant validation team
  • Ensure security and data integrity of the IT infrastructure and operations
  • Develop and implement disaster recovery programs
  • Lead or assist in troubleshooting of networks and computer driven laboratory instruments and automated manufacturing equipment and systems
  • Manage all stages of IS projects with minimal direction including planning, implementing, reporting progress and solving challenges
  • Maintain and evaluate hardware and software needs
  • Develop training programs for new and existing systems
  • Manage changes and change control documentation related to IS related projects
  • Manage relationships with external resources and vendors
  • Recruit, train and manage direct reports
  • Assist with DEA security and control activities
  • Develop budgets for the Information Systems department

 Preferred Knowledge, Skills and Abilities: 

  • Ability to plan and manage well in order to deliver high quality results on time
  • Extensive technical experience managing the IS function for an organization
  • Demonstrated knowledge of modern Information Systems and new technology, preferably in a regulated manufacturing environment
  • Understanding of current Good Manufacturing Practices (cGMPs)
  • Proven team player with well-developed interpersonal, organizational and communication skills, including written documentation and presentation skills
  • Interested in learning and applying new technologies
  • Ability to change priorities in response to company demands while continuing to deliver results
  • Experience in computerized system validation in the pharmaceutical industry is a plus

 Desired Skills and Experience

  • BS in Computer Science, Information Systems or related field
  • 7 years of applicable experience with at least 4 years in a leadership role
  • Excellent technical writing, project management and exceptional organizational skills
  • Good interpersonal skills and the ability to work well in a team environment
  • Enthusiasm for building a company with outstanding work ethic; must be able to perform in a fast paced multiproduct environment
  • Able to shift the priorities of the team quickly while continuing to deliver exceptional work quality
  • Enthusiasm for working in teams and collaborating with both internal and external colleagues
  • Proven ability to train staff on complex analytical equipment and processes