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

Browse through our available positions

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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In this hands-on position, the primary responsibilities of the Scientist will be to develop liquid formulations suitable for nasal, buccal or sublingual administration. This position is also responsible for extensive technical writing, leading spray product development projects and for designing, executing and summarizing a wide range of studies using Quality by Design (QbD) principles and methodologies.

Essential Functions:

  • Formulate and design nasal spray drug products using QbD methodologies
  • Design and execute stability studies for prototype formulations
  • Assist with method development, validation and characterization for multiple products
  • Manage projects and participate on project teams
  • Perform data reviews, prepare reports and quality documents
  • Prepare analytical sections of regulatory filings
  • Author technical reports, SOPs, protocols, regulatory sections in CTD format and other development and cGMP related documents

Desired Skills & Experience

The individual must have experience in an FDA regulated cGMP laboratory environment. Additionally, the Scientist possesses:

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

Minimum Qualifications:

  • Bachelors degree in Chemistry or related field with not less than three years of relevant experience in an FDA regulated cGMP environment
  • Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules
  • Experience with nasal spray drug product development and characterization preferred

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

Required education:

  • Bachelor's

Required experience:

  • Pharmaceutical Development: 3 years
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The IT Associate will be responsible for various aspects of the start-up, operation, maintenance and hands-on administration of plant information systems. The IT Associate will also lead or assist in the installation, maintenance, upgrade and support of all company servers, website, specialty computer systems and network security.

The IT Associate is responsible for leading projects to upgrade or troubleshoot computer related systems, source and implement new equipment, increase efficiencies, and serve as a technical expert on information technology related issues.

Essential Duties:

  • Provide day to day support for all information management systems.
  • Install hardware, software and other technology.
  • Backup of information management systems per company procedure.
  • Design, install and upgrade information systems to meet company needs.
  • Design, install and upgrade network security devices to provide protection from current outside threats, such as viruses, trojans, hackers, etc.
  • Provide technical input to equipment design and upgrades.
  • Assist with troubleshooting and repair of information management systems and equipment.
  • Manage projects such as; new equipment design and procurement, technology transfer, and process optimization.
  • Manage and maintain building access control systems, security system and video surveillance system.
  • Work on computerized systems acceptance, installation, startup, optimization and validation activities.
  • Write and revise SOPs and Forms to maintain up to date and accurately reflect the current procedures for information management systems.
  • Other duties as assigned.

Candidate Attributes:

The IT Associate possesses these qualities:

  • Motivated self-starter with excellent organizational skills and attention to detail.
  • Strong interpersonal and communication skills and demonstrated ability to effectively communicate with all departments including coordination of activities with manufacturing and laboratory personnel.
  • Motivated to perform work while maintaining a focus on the long-term, continuous improvement of equipment, utility, and facility operation and the programs that support manufacturing.
  • 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 and the ability to and write SOPs and complete documents.

Qualifications:

  • BS in Computer Science, Information Systems or related field.
  • 3-5 years of hands-on experience, preferably in a FDA regulated cGMP environment.
  • CCNA, MCSA or MCSE Certification.
  • Experience with SQL and Oracle.
  • Experience with Linux.
  • Excellent technical writing and organizational skills.
  • Self-starting and multitasking.
  • Extremely detail oriented.
  • Ability to work with cross functional teams and meet performance requirements.
  • Good interpersonal skills and the ability to work well in a team environment.
  • Qualified to work with controlled substances.
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

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 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/review of lot records prior to submitting to QA
  • Maintain assigned manufacturing area neat, clean and well stocked with supplies
  • Assist with the training of other manufacturing team members
  • Coordinate manufacturing activities with other departments
  • Help identify continuous improvement and cost savings opportunities
  • Assist with equipment and facility maintenance activities as needed
  • Adhere to cGMPs, SOPs, and Safety policies
  • Other assigned duties as required

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

Minimum Qualifications:

  • High School diploma or equivalent and 1-2 years of previous manufacturing experience
  • Pharmaceutical experience a plus
  • Problem solving or troubleshooting skills
  • Demonstrated mechanical aptitude
  • Good oral and written communication skills
  • Strong interpersonal skills and the ability to work well in a team environment
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

Responsible for keeping manufacturing clean rooms and equipment in a clean and organized state. Expertise on all Manufacturing processes and documentation.

Essential Duties:

  • Clean and organize manufacturing areas as required by applicable SOPs
  • Document activities following current GDPs
  • Stay current on pharmaceutical industry documentation practices
  • Clean equipment as required by applicable SOPs and batch records
  • Monitor manufacturing area conditions to ensure they are operating within specifications
  • Assist with manufacturing activities as needed
  • Formulate cleaning solutions
  • Adhere to cGMP's, SOPs, and Safety policies
  • Other duties as required

Candidate Attributes:

  • Excellent organizational skills and attention to detail
  • Strong interpersonal and communication skills
  • Experience in a cGMP manufacturing environment
  • Self-starting and ability to multitask
  • Ability to change priorities in response to company demands while continuing to deliver results
  • Enthusiasm for building a company with outstanding work ethic; must be able to excel in a fast-paced, multiproduct environment
  • Enthusiasm for working in teams and collaborating with internal colleagues

Qualifications:

  • 1+ years of applicable experience working in a pharmaceutical manufacturing environment is required
  • Experience with documentation in a regulated industry
  • Strong interpersonal skills and the ability to work well in a team environment
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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
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Responsible for assisting with the operations of the QC laboratory including raw material and component sampling and testing, in-process and finished product release, stability testing, assisting in analytical methods transfers and validations, instrument maintenance, document generation and review, and other duties as assigned.

Essential Duties:

  • Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing.
  • Assist in maintaining the laboratory in accordance with SOPs, cGMPs, OSHA and FDA regulations. This may include performing daily, weekly, and monthly laboratory procedures.
  • Assist in the development and validation of analytical methods.
  • Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.
  • Write, revise and review Standard Operating Procedures, Material Specifications, Forms, and Protocols.
  • Assist in conducting and documenting laboratory investigations.
  • Maintain supplies inventory
  • Coordinate instrumentation maintenance and repair work.
  • Other duties as assigned.

Qualifications:

  • Bachelors degree in Chemistry, Biology, Microbiology or related field
  • Experience performing laboratory analyses is preferred
  • Good technical writing and organizational skills
  • Experience with Microsoft Office programs
  • Good interpersonal skills
  • Ability to work well in a team environment
  • Qualified to work with controlled substances
Apply Now

We are currently seeking a QA/Regulatory Specialist. This position is responsible for providing quality involvement and oversight during pharmaceutical development, manufacturing and testing. Also responsible for assisting in the management of regulatory correspondences related to the drug products manufactured at the site.

Responsibilities and Duties

  • Supports the development and maintenance of Quality Systems as appropriate.
  • Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
  • Advises senior management on findings and recommendations related to internal and external auditing.
  • Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents.
  • Develops and maintains metrics and trending reports for Compliance-related activities.
  • Reviews and approves product complaint investigations and assists with investigations.
  • Performs activities associated with various one-time or on-going projects (from participation level to project manager).
  • 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.
  • Author and review regulatory documents in CTD format.
  • Assist with tracking, compiling, and maintaining site regulatory files.
  • Provide regulatory advice and guidance to other departments to ensure compliance with FDA regulations and requirements.
  • Assist in managing with the product life cycle through post approval submissions
  • Assists Manager with daily and project activities as needed.
  • Other duties as assigned.

Qualifications and Skills

  • Bachelor degree in a scientific discipline
  • At least 3 years Pharmaceutical cGMP quality/regulatory experience
  • Direct knowledge and preparation of regulatory dossiers (IND, Annual Report, ANDA, NDA, etc.).
  • Working knowledge of US regulations and guidance documents.
  • Ability to work independently with minimal oversight as well as collaboratively with cross functional teams.
  • Excellent technical writing, communication and organizational skills.
  • Exceptional interpersonal skills and the proven ability to work well with cross functional teams to meet performance requirements.
  • Working knowledge of cGMPs, cleanrooms, and pharmaceutical processing and plant equipment.
  • Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment.
  • Qualified to work with controlled substances

Job Type: Full-time

Required education:

  • Bachelor's

Required experience:

  • pharmaceutical cGMP quality/regulatory: 3 years
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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

Summary: The Accounts Payable Associate must be a reliable and precise professional capable of maintaining accounts payable information. Accounts Payable Associate will maintain current accounts and assist with invoicing functions. We are seeking an experienced candidate who can analyze expense reports to assign payments to the proper cost centers, work with vendors to resolve past due invoices and reconcile monthly statements with vendors.

Responsibilities and Duties

Essential Duties:

  • Review all Purchase Requisitions for accuracy and completeness
  • Generate Purchase Orders as requested by departments
  • Maintain and log all outgoing disbursements*
  • Monitor all vendor payment agreements to find discounts that can be used to reduce invoice amounts* *
  • Record and pay all sales tax on appropriate invoices* *
  • Keep track of credits owed to the company and ensure all credits are properly applied to vendor payments* *
  • Monitor and record all credit card purchases* *
  • Open and process mail daily* *
  • Reconcile payable reports each month to confirm that all amounts paid were accurate* *
  • Resolve disputes with vendors and other departments as they relate to accounts payable management* *
  • Ensure that accounts payable reports are submitted to all managers and other staff on a regular basis or as requested* *
  • Establish or maintain credit policy of Company* *
  • Maintain appropriate documents and other information in the vendor files* *
  • Other projects and responsibilities as assigned*

Qualifications and Skills

Required Skills:

  • Effective listening, verbal and written communication skills
  • Judgment and decision-making ability
  • Accuracy and attention to detail
  • Demonstrated integrity and ethical standards
  • Problem-solving and analytical ability
  • Ability to perform business math (basic algebra, compute ratios, etc.)
  • Effective time management & quick adaptation to changing priorities
  • Teamwork and ability to work productively with diverse set of people
  • Superior organizational skills
  • Ability to maintain poise in a fast-paced environment
  • Strong multi-tasking skills
  • Ability to consistently meet all deadlines
  • Capable of following written instructions and documented procedures
  • Working knowledge of basic accounting principles

Qualifications:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • High school diploma or general education degree (GED) required
  • Minimum Associates degree in Accounting, Finance or related discipline preferred
  • Minimum 2 years experience working with Quickbooks
  • Minimum 2 years in similar position (4 years preferred)
  • Knowledge of Microsoft Office Suite, particularly Excel
  • Qualified to work with controlled substances (Must be able to pass drug screen.)

Job Type: Full-time

Required education:

  • High school or equivalent

Required experience:

  • Accounts Payable: 2 years
Apply Now

Job Summary

We are currently seeking a Microbiology Department Coordinator. In this hands-on position, the Coordinator is responsible for the operation of the Quality Control Microbiology laboratory. Coordinates raw material and component testing, method development and validation, contract testing, environmental monitoring, in-process and finished product microbiological testing. Methodologies include: Bioburden, Sterility, Particulate Matter, Container Closure Integrity, Antimicrobial Effectiveness, Microbial Identifications and others.

Responsibilities and Duties

  • Oversight of the environmental monitoring program and related trending.
  • Write SOPs, programs and specifications necessary for laboratory operations.
  • Validate microbiological laboratory equipment.
  • Develop and validate methods for raw material, in-process and finished product testing per appropriate GMP, USP, EP and ICH requirements or guidelines.
  • Participate in the validation of the manufacturing plant systems and processes.
  • Coordinate the laboratory in accordance with GMPs, OSHA, DEA and FDA regulations.
  • Develop quality systems for microbiology including specialized training programs.
  • Write technical reports and perform data trending analyses.
  • Supervise, perform and resolve out-of-specification investigations and implement corrective and preventive actions.
  • Train and supervise 1 or more direct reports.
  • Coordinate projects related to establishing new capabilities and/or drug development programs.
  • Participate in DEA licensing and reporting activities.
  • Interface with clients and partners as related to microbiological testing.

Qualifications and Skills

  • BS in Microbiology or related field
  • 5-10 years of applicable experience in a pharmaceutical microbiology laboratory
  • Knowledge and experience in an aseptic processing environment is preferred
  • Hands on experience using laboratory instrumentation
  • Experience performing microbiological testing and environmental monitoring
  • Experience in microbiological method development and method validations
  • In depth knowledge of cGMP regulatory requirements
  • Ability to supervise and develop staff
  • Excellent technical writing and organizational skills
  • Qualified to work with controlled substances
  • Good interpersonal skills and the ability to work well in a team environment

Job Type: Full-time

Required education:

  • Bachelor's

Required experience:

  • pharmaceutical microbiology laboratory: 5 years
Apply Now