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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RESPONSIBILITIES:

  • Independently performs all routine tests that occur in the lab as needed
  • Qualifies instruments in the lab with vendor and supervisor/Sr Chemist support and as needed
  • May develops methods with minimal supervisor/Sr Chemist support, as needed
  • Validates methods with minimal supervisor/Sr Chemist support, as needed
  • Writes documents with minimal supervisor/Sr Chemist support, as needed
  • Investigates OOS, OOT, and aberrant results
  • Performs all routine instrument maintenance and lab responsibilities as assigned
  • Independently reviews data, protocols, reports

DEMONSTRATED KNOWLEDGE, SKILLS and CHARACTERISTICS:

  • High level of confidence to complete tasks
  • High level understanding of cGMPs
  • Understanding of Analytical Chemistry including but not limited to the following techniques and how to utilize them for simple projects as assigned:
    • HPLC
    • Nasal Spray Testing
    • Andersen Compaction Testing
    • UV/Vis
    • FTIR
    • SPE
    • Sample Preparation Techniques
    • GC
    • MS
    • Titration/electrode chemistry
    • Others as appropriate
  • Strong oral and written communication skills. Can clearly and concisely articulate details in a professional manner.
  • Accountable and fair: maintain accountability to themselves and their team.
  • Maintains proper social etiquette and self-control when dealing with stressful situations.

SPHERE OF INFLUENCE

  • Participates in finding solutions to analytical problems
  • May participate in technical discussions with other departments
  • Mentor to coworker
  • No direct reports
  • Reports to supervisor

EDUCATION AND EXPERIENCE:

  • PhD in chemistry with at least 1 years of pharmaceutical industry experience
  • MS in chemistry with at least 2 years of pharmaceutical industry experience
  • BS in chemistry or related field with at least 6 years of pharmaceutical industry experience
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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
Apply Now

Responsible for performing maintenance and calibration activities in a pharmaceutical cGMP manufacturing facility. This includes following procedures to perform and document instrument calibrations, preventive maintenance, troubleshoot and repair process equipment, utility, and facility issues and proactively improve existing and new equipment, utilities, and facilities. Additionally, manage inventory of spare parts and provide technical input for new equipment purchases and plant expansion activities.

Essential Duties:

  • Operate, monitor, calibrate and maintain equipment and systems used to support manufacturing and laboratory operations.
  • Complete PM records, equipment logs and other forms to document work activities.
  • Maintain an adequate inventory of spare parts for all plant and manufacturing equipment.
  • Complete emergency repairs in a high quality, timely manner to minimize downtime.
  • Discover, evaluate and recommend mechanical, electrical, control system or equipment upgrades to continually improve quality, safety, and reliability and reduce costs.
  • Write and revise SOPs, PM cards and Forms to maintain up to date and accurately reflect the current procedures.
  • Keep all plant systems and manufacturing equipment well maintained and operating efficiently.
  • Maintain assigned areas neat and orderly and in compliance with SOPs and cGMPs.
  • Perform validation and equipment qualification activities.
  • Other duties as assigned.

Candidate Attributes:

  • Excellent organizational skills and attention to detail.
  • Motivated to perform work while maintaining a focus on long-term learning and self improvement.
  • Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.
  • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and with partners.
  • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
  • Strong listening, writing, reading, and verbal communication skills.

Qualifications:

  • High School Diploma or equivalent
  • Minimum of 2-5 years of previous work experience in maintenance, calibration or related trade.
  • HVAC certification, trade school or engineering education is preferred.
  • Experience maintaining or calibrating equipment and utilities such as sterilizers, ovens, USP water systems, HVAC systems, and precision manufacturing equipment is preferred.
  • Good written communication skills to read and write SOPs and complete cGMP documents.
  • Good interpersonal skills and the ability to work well in a team environment.
  • Qualified to work with controlled substances
Apply Now

Job Summary

The Manufacturing 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 collaboratively identifying/implementing process improvements, writing/executing validation protocols, summarizing results into reports, and supporting all production activities as needed. The ideal candidate will be able to assist in troubleshooting, equipment/facility design, and cost improvement projects. Training in project management, the TPS, or Six Sigma will be beneficial.

Responsibilities and Duties

  • Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing processes to manufacture and package multiple types of nasal spray drug products
  • Assist in the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports
  • 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
  • Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
  • Point person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
  • Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules.
  • Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA’s through participation on cross functional teams
  • Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, and support of out-of-tolerance investigations related to instrument calibrations
  • Participate in plant engineering, maintenance and calibration activities as needed
  • Other duties as assigned

Qualifications and Skills

  • BS in engineering or related life science
  • Minimum of 2-5 years of previous work experience in a related field
  • Working knowledge of cGMPs and regulatory requirements is preferred
  • Excellent communication skills, organizational skills, computer skills
  • Strong analytical and problem solving skills
  • Ability to work in/with cross-functional teams
  • Six Sigma Training is a plus
  • Ability to maintain focus on tasks until completion and think analytically to solve problems
  • Ability to apply statistics and process capability methodologies to evaluate processes and implement and monitor improvements
  • Strong work ethic; ability to excel in a fast paced, multiproduct environment
  • Good mechanical aptitude
  • Excellent technical writing and organizational skills; detail oriented
  • Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment

Job Type: Full-time

Required experience:

  • Manufacturing Engineering: 2 years

Required education:

  • Bachelor's
Apply Now

Responsible for performing and leading manufacturing and validation related activities in a cGMP environment. The scope of the position includes executing and reviewing SOPs, Production Batch Records (PBRs), Forms and validation documents. This individual will train Manufacturing Technicians to perform work in a safe, accurate and timely manner, assuring cGMP compliance. May also perform routine preventive maintenance activities.

Essential Duties:

  • Lead activities to manufacture sterile nasal spray products in a cGMP environment.
  • Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.
  • Understand daily priorities in order to organize daily activities and job assignments within designated process operation.
  • Ensure team compliance with Summit Biosciences, Inc. Employee Handbook lunch and rest policies.
  • Report daily progress to Manufacturing Management.
  • Set the pace of the process operation to ensure work is performed in a consistent manner while maintaining high safety and quality standards
  • Complete PBRs, Logbooks, Forms, and other documentation.
  • Train technicians on safety, PBRs, SOPs, and cGMPs.
  • Assist in compilation and review of lot records prior to submission to QA.
  • Review SOPs and Forms to ensure they accurately reflect the current procedures.
  • Maintain an inventory of supplies necessary for manufacturing.
  • Maintain the manufacturing area in a neat and clean manner.
  • Assist or conduct investigations to resolve deviations.
  • Coordinate manufacturing, calibration, and maintenance activities with other departments.
  • Execute and review validation protocols for manufacturing support equipment.
  • Independently champion manufacturing or facility related improvement projects.
  • Participate in the performance of routine preventive maintenance on facilities and equipment.
  • Help identify continuous improvement and cost savings opportunities.
  • 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 with 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.
  • 2 - 5 years of applicable experience working in a pharmaceutical manufacturing environment.
  • Experience with sterilization processes or aseptic technique preferred.
  • Qualified to work with controlled substances.
Apply Now

Responsible for performing manufacturing and validation related activities in a cGMP environment. The scope of the position includes executing and reviewing SOPs, Production Batch Records (PBRs), Forms and validation documents, This individual will train Manufacturing Technicians to perform work in a safe, accurate and timely manner, assuring cGMP compliance. May also perform routine preventive maintenance activities and participate in validation projects.

Essential Duties:

  • Participate in activities to manufacture sterile nasal spray products in a cGMP environment.
  • Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.
  • Complete or review PBRs, Logbooks, Forms, and other documentation.
  • Assist in compilation and review of lot records prior to submission to QA.
  • Train technicians on safety, PBRs, SOPs, and cGMPs.
  • Review SOPs and Forms to ensure they accurately reflect the current procedures.
  • Maintain an inventory of supplies necessary for manufacturing.
  • Maintain the manufacturing area in a neat and clean manner.
  • Assist or conduct investigations to resolve deviations.
  • Execute and review validation protocols for manufacturing support equipment.
  • Independently champion manufacturing or facility related improvement projects.
  • Participate in the performance of routine preventive maintenance on facilities and equipment.
  • Help identify continuous improvement and cost savings opportunities.
  • 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.
  • Good mechanical aptitude
  • Pharmaceutical experience is preferred.
  • Experienced with Microsoft Word and Excel.

Qualifications:

  • BS in a scientific discipline or equivalent experience
  • 3-7 years of experience in a cGMP manufacturing environment including hands-on manufacturing or validation experience
  • Experience with sterilization processes and aseptic technique preferred
  • Qualified to work with controlled substances
Apply Now

Job Summary

The ideal candidate is responsible for performing and managing equipment, cleaning and process validation activities. The job includes writing protocols, reports, compiling data and attachments into comprehensive validation packages. Additionally responsible for assisting with the development of procedures, specifications, validation master plans and other validation and engineering related documentation. May also participate in design, build activities, equipment procurement, optimization and troubleshooting of equipment and processes, hiring and development of staff.

Responsibilities and Duties

  • Work on multiple validation projects simultaneously and coordinate test work
  • Support coordination of all equipment qualification, cleaning and process validation activities and projects
  • Write protocols for manufacturing, utilities, lab equipment and processes
  • Execute validation work according to protocol instructions and procedures
  • Plan, coordinate and track the progress of validation projects
  • Compile validation packages and assure all required documentation is complete
  • Identify and champion process improvement projects and ensure equipment and systems remain in a qualified state
  • Assure compliance with quality policies and procedures related to validation activities
  • Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure
  • Work with QA and other groups to validate drug product manufacturing
  • Writing, review and approval of technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents
  • Train personnel to write, execute and summarize studies and oversees work
  • Perform qualification activities under ISPE, GAMP, and ICH guidelines
  • Support maintenance activities including review/approval of preventative maintenance tasks, calibration, drawing updates, related investigations
  • Lead risk assessment exercises related to equipment and processes (FMEA, VSM, etc)
  • Maintain strict deadlines to minimize impact to production and maximize equipment/process efficiency
  • Participate in equipment/process design, specification of use requirements and factory acceptance testing
  • Other duties as assigned

Qualifications and Skills

  • BS in Biology, Chemistry, Engineering or related science or equivalent experience
  • 2-5 years of validation experience in a cGMP manufacturing environment
  • Excellent working knowledge of cGMPs and regulatory requirements is preferred
  • Excellent technical writing and organizational skills
  • Self-starting and multitasking
  • Detail oriented
  • 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
  • Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements
  • Knowledge of calibration methodology, equipment, and instruments.
  • Knowledge of software including: CAD, Minitab, and Microsoft Office

Job Type: Full-time

Required experience:

  • Validation: 2 years

Required education:

  • Bachelor's
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Under general supervision, perform warehouse functions to support all internal and external customers in an accurate and timely manner. These functions include but are not limited to shipping and receiving, material stocking, material issuance, cycle counting, inventory reconciliation, facility waste handling, general housekeeping, and maintaining accurate clerical records in a GMP-regulated environment.

Essential Duties:

  • Maintain warehousing operations in a neat, clean, secure and orderly manner in compliance with SOPs, cGMPs and DEA requirements. Perform routine housekeeping duties in warehouse and work areas in compliance with SOPs. All logs pertaining to cleaning and pest control must be legible and kept up to date in accordance with procedures.
  • Perform cycle counts and physical inventories. Research, reconcile and correct inventory discrepancies.
  • Complete Log Books, Forms and other documentation. Sort and file inventory records.
  • Shipping, receiving and stocking. Duties may include loading/unloading trucks, sorting, sizing for materials, stacking and loading pallets, damage inspection, shipment packaging and data entry.
  • Perform stocking and issuing materials to appropriate internal locations, including various warehouse storage locations and Manufacturing areas.
  • Operate pallet jacks and lifts. General forklift maintenance and reporting maintenance necessities.
  • Manual dexterity to perform all clerical and warehouse related functions of the job.
  • Adhere to cGMPs, SOPs, and Safety policies.
  • Other assigned duties as required.

Qualifications:

  • High School diploma or equivalent with 2 - 5 years experience.
  • Experience in a production environment working with PC for data entry, inquiry and communication. Ability to keep neat, accurate and complete records and logs.
  • Experience with pharmaceutical related healthcare manufacturing clean environments is preferred. Basic understanding of cGMPs, FDA regulations and industry guidelines is preferred.
  • Good verbal and written communication.
  • Operation of pallet jacks and lifts. Forklift experience in a warehouse environment is preferred.
  • Must be proactive, dependable, results-oriented, with a strong attention to detail.
  • Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment.
  • Qualified to work with controlled substances.
  • Strong interpersonal skills and the ability to work well in a team environment.
Apply Now

Job Summary

The Accounting Manager functions as a business support person to the manufacturing, material procurement and financial management teams. The incumbent is responsible for plant level costs and controls including cost accounting, bill of material audits, and cost analysis. He or she will also oversee the activities of the Corporate Accounting Department which include accounts payable, accounts receivables, treasury functions and budgets and forecasts.

The incumbent will work closely with all department leaders to understand issues and how they impact the financial results as well as educate/inform department(s) on cost drivers and variances.

Responsibilities and Duties

  • Oversee the activities of the accounting department for the accurate and timely analysis and presentation of financial reports.
  • Develop and maintain financial and cost accounting processes and controls. Analyze existing procedures/policies and make recommendations/decisions to change.
  • Develop and adjust standardized costs for labor, materials and overhead.
  • Analyze actual labor, material, and overhead cost against standard/budget. Research and explain variances. Report this information monthly or as needed
  • Perform ad hoc product/plant cost analysis to support the operations.
  • Proactively assist or lead in developing projects to identify opportunities for cost savings and profit enhancement throughout the organization.
  • Provide accounting related advice and counsel to internal employees. Lead cross functional teams for accounting related projects.
  • Prepare corporate budgets and forecasts
  • Report on corporate actuals vs. budgets/forecasts
  • Provide work direction/support to accounting personnel as required
  • Assist in invoicing on a monthly basis as needed
  • Additional responsibilities per management

Qualifications and Skills

  • 3-5 years in a cost accounting position in a pharmaceutical manufacturing environment and 2–4 years experience in general accounting and financial reporting.
  • Bachelor’s degree in Accounting, Finance or related field is required. CPA certification is preferred.
  • Exposure to pharmaceutical manufacturing departments/staff/activities, cost accounting, reporting and variance analysis.
  • Experience in identifying, developing and creating systems and processes to support a rapidly growing company.
  • Strong technical skills in both general and cost accounting.
  • Strong managerial abilities with a commitment to leading by example.
  • Demonstrated ability to teach, train, and develop staff both from a technical perspective as well as in professionalism and professional skills such as time management, polished communication, etc.
  • Ability to promote and implement a culture of high achievement and continuous improvement through goal setting and measurement.
  • Ability to assemble and lead cross functional teams and coordinate with operations department.
  • Communicate with co-workers, management, clients, and others in a courteous and professional manner.
  • Very strong organizational skills, attention-to-detail, and commitment to accuracy.
  • Ability to multi-task and work in a fast-paced team environment efficiently and effectively. Strong time and project management skills a must, including experience creating, prioritizing, scheduling, tracking, reviewing, and ensuring completion of tasks by set deadlines.
  • Display follow-through on all tasks and a readiness to do what it takes and work overtime if necessary in order to complete assignments and meet deadlines.
  • Demonstrate initiative and drive, including a willingness to pitch in with projects and areas beyond Accounting and Finance.
  • Display intellectual curiosity and willingness to become a student of the business and the industries in which the Company operates.
  • Team player with a positive attitude, good sense of humor, and a desire to learn and grow with the Company.
  • Ability to drive projects through to completion by involving and persuading others
  • High level of proficiency with Microsoft Outlook, Word and Excel required, including strong Excel skills (v-lookup, pivot tables, complex formulas, advanced charting)
  • High level of proficiency using QuickBooks
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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
Apply Now

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
Apply Now