Career Opportunities

Manufacturing Operator

Summary

The role of the manufacturing operator is to perform production activities including Equipment preparation, Formulation, Filling, Inspection, and Packaging. Collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.

Qualifications

  • High school education or equivalent.
  • BS in Biology, Microbiology, Chemistry, Bio-Tech or Engineering preferred (current students may apply).
  • Experience in an aseptic manufacturing environment preferred.
  • Must be familiar with a variety of production equipment.

Primary Responsibilities

Line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
  • Operate and maintain production equipment.
  • Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.
  • Execute validation protocols for processes and equipment.
  • Maintain records and a clean environment to comply with regulatory requirements.
  • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
  • Review/update current SOPs as well as write new SOPs.
  • Lead troubleshooting and process improvement activities including corresponding documentation activities.
  • Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
  • Initiate appropriate action when process deviations occur.
  • Perform on job training for new and developing operators.

Other duties as assigned by leadership team.

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Analytical Quality Control Chemist II

Summary

The Chemist II of Analytical Quality Control has responsibility of performing complex testing of raw materials and finished products, maintenance and calibration of analytical instruments in compliance with cGMP. The position will provide assistance to analytical quality control manager to meet projects timelines and improve laboratory compliance.

Primary Responsibilities

  • Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc with minimum supervision.
  • Participate in analytical method validation for intermediate precision study.
  • Involve testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
  • Proficient at HPLC/GC analysis
  • Document laboratory work according to cGMPs and SOPs 
  • Troubleshoot, calibrate and maintain instruments as required.
  • Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
  • Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
  • Initiate and resolve laboratory investigations.
  • Train and provide guidance to entry level QC personnel and be a subject matter expert in laboratory practices.
  • Perform peer review of analytical documentation.
  • Follow safety procedures when working in laboratory.
  • Understand and comply with cGMPs and other regulations. 
  • Maintain the laboratory in an organized and neat manner.

 

Qualifications

  • BS degree required, preferred in science degree. Require minimum of 3 years quality control working experience.
  • Familiar with fast paced contract manufacturing environment and be able to work under pressure while maintain high quality.
  • Experience working with potent, or cytotoxic materials preferred. 
  • Working experience with parenteral drug products preferred.
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Analytical Scientist

Summary

The Analytical Scientist is responsible for the development and validation of analytical methodologies used in analytical laboratory.  In addition the Analytical Scientist performs analytical tasks using modern analytical pharmaceutical instrumentation (chromatographic, spectroscopic), or traditional physical and wet-chemical technique.  

Primary Responsibilities

  • Issue the New Product Assessment report to provide safety and cleaning information. 
  • Develop, establish, validate and transfer analytical methods as assigned.
  • Work with various analytical methods including cleaning verification, assay and impurities, dissolution, and residual solvents for API’s, in-process control, finished products, and excipients analysis.
  • Familiar with chromatographic (HPLC/GC) and spectroscopic technique
  • Perform physical and wet chemical methods verification if applicable.
  • Routinely discuss the status of assignments and potential problem with supervisor. 
  • Providing regular communication to internal and external customers via written reports and teleconferences.
  • Review, analyze data and information for technical correctness and accuracy, interpret and evaluate results properly.
  • Maintaining compliant documentation for all laboratory experimentation.
  • Submit complete experimental records for review.  Ensure data is filed and accessible for retrieve in accordance with applicable standard operating procedures.
  • Perform initial and stability testing for R&D lab batches and demonstration batches to support formulation development.
  • Perform laboratory instrumentation qualification, preventative maintenance, calibration and minor repair with proper documentation as needed.
  • Write and review Standard Operating Procedures, analytical deviations and laboratory investigations as needed.
  • Organize the workload and coordinate activities to carry out multiple projects concurrently and in accordance established objectives, timelines and deadlines.
  • Exhibit safety awareness and conduct laboratory operations and chemical disposal in a safe manner, maintain a clean and organized work environment.
  • Maintain familiar with current, relevant scientific literature and technologies.
  • Demonstrate a high level of professionalism, enthusiasm, dedication and productivity.

Qualifications

  • Bachelor’s degree, Master’s or PhD in chemistry, pharmaceutical sciences, or other related field.
  • At least 0-3 years of experience in pharmaceutical analytical development / quality control.  
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Senior Validation Specialist

Summary

The Senior Validation Specialist reports directly to the Validation Supervisor and will perform specific assigned duties and undertake project work within the Validation Department.  

Primary Responsibilities

  • Write, schedule, plan, manage and execute validation and qualification protocols
  • of manufacturing, packaging, laboratory, utility systems and other equipment in accordance with 
  • current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change 
  • control. 
  • Directly interact with Coldstream Clients and regulatory agencies
  • Responsible for managing validation department in the absence of the Validation Supervisor
  • Responsible for reviewing executed qualification protocols and drafted documents by other Validation staff
  • Author summary reports for qualification protocols.
  • Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities.
  • Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to assure successful project execution.
  • Lead qualification activities and timelines for equipment purchased for manufacturing purposes. Coordinate order timelines and equipment requirements with Technical Services group.
  • Represent validation at project team meetings and provide expert validation advice.
  • Perform routine duties as required in order to ensure the timely generation of accurate data and information.
  • Independently design, plan and manage own studies.
  • Maintain and develop state of the art knowledge applicable to existing and future validation processes and maintain up-to-date knowledge on regulatory expectations.
  • Lead investigations related to validation discrepancies and assure thoroughness of investigation, documentation and closure. Implement preventive/corrective actions as necessary.
  • Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
  • Author assigned Standard Operating Procedures (SOPs) for Validation department.

Qualifications

  • Bachelor’s degree in engineering or science required
  • Minimum of five years experience working in a GMP environment, with a minimum of three years of validation experience. 
  • Must have excellent technical writing skills and problem solving ability.
  • Sound knowledge, understanding, and application experience of quality management systems such as Deviations, CAPAs, Change Controls, etc.
  • Must be independent, detailed oriented, have the ability to manage own time, be flexible, tactful, and team oriented, balancing as appropriate.
  • Validation experience with manufacturing facilities/areas (e.g. multi-product facility, warehouse, cold rooms, autoclaves, depyrogenation ovens)
  • Strong computer and communications skills
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Microbiology Technician

Summary

The Microbiology Technician is responsible for performing and maintaining the environmental monitoring programs for the facilities and water systems used at CLI. The Microbiology Technician will aide Microbiology Staff in sample collection, operation of test equipment, and trend data entry to facilitate the compliance aspect of the microbiology laboratory.

Primary Responsibilities

    • Perform environmental monitoring throughout batch production.
    • Assist in the performance and documentation for environmental monitoring of the facilities and water systems in compliance with Standard Operating Procedures.
    • Adhere to all applicable regulations, policies, and procedures for health, safety and environmental compliance. 
    • Aide in completion of environmental monitoring related investigations through coordination and communications with other applicable departments.
    • Assist in Microbiology material inventory maintenance.
    • Assist in keeping all documentation current within the Microbiology Laboratory.
    • Assist in the coordination of batch manufacturing items with Operations and other applicable departments.
    • Assists in and drives achievements of departmental goals and commitments, regardless of obstacles.
    • Complete the appropriate training on cGMP, and demonstrate knowledge of the pharmaceutical industry expectations.
    • Assist in the performance and documentation for Cleaning Verification sample collection and analysis in compliance with Standard Operating Procedures and applicable Test Methods.
    • Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
    • Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions.
    • Maintain GMP documentation relevant to the duties and responsibilities assigned.
    • Maintain laboratory instrumentation required for testing.
    • Assist in the review of test data and report any deviations to management.
    • Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives.
    • Participate in projects involving the Quality Control and/or Microbiology departments.
    • Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
    • Perform other related duties as required and assigned by Microbiology Management.

Qualifications

  • BS or greater in Biology or related sciences preferred.
  • Working knowledge and practical experience with good laboratory practices and competency with microbiology techniques such as Gram staining, isolation plating, aseptic practice, and microorganism identification methods.
  • Experience with common microbiology lab instrumentation is ideal, especially with autoclaves, light microscopes, and biohazard safety cabinets. 
  • Practical hands on experience with basic lab equipment such as pH meters, balances, water baths and other equipment common to microbiology methods.
  • Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook).
  • Must understand basic lab safety, bio-hazard and chemical waste disposal practices
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Senior Quality Assurance Scientist

Summary

The Quality Assurance Senior Specialist ensures complicance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.  This position will help to further develop Coldstream's overall cGMP compliance and to support the day-to-day performance of cGMP compliance throughout the company.  The position will report directly to the Quality Assurance Manager.

Primary Responsibilities

  • Experience with conducting GMP investigations
  • Strong knowledge of GMP regulations, guidance, and general compliance expectations

Qualifications

  • Bachelor's degree in a scientifi discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment with at least 3 years in QA
  • Good understanding of sterile manufacturing is required
  • Knowledge of cGMP and applicable FDA regulations
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Project Management Associate

The Project Management Associate is responsible for assisting their assigned project manager(s) in the planning, execution, and client satisfaction of assigned projects.  

 

Primary Responsibilities

In collaboration with the project management team this role will assist with the following:

  • Coordinate project meetings
  • Coordinate client visits
  • Coordinate project timelines into global PM schedule
  • Prepare/edit project meeting minutes and presentations
  • Prepare project related shipment requests and controlled materials number requests
  • Ensures SharePoint BD and PM internal webpage is current with client visits, pertinent projects documents, etc.
  • Prepare/edit project scope changes
  • Monitor time tracking system for compliance
  • Assist in the roll=out of new department systems to harmonize Coldstream Project Management

Qualifications

  • Pharmaceutical industry experience (2 years preferred)
  • Project coordination/management experience (1-2 years preferred)
  • Experience with Microsoft Office required; Microsoft Project preferred
  • Bachelors degree
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