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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Process Engineer

Summary

The Process Engineer reports directly to the Director of Technical Services and is responsible for the development and execution of process engineering projects for pharmaceutical manufacturing and packaging equipment. The responsibility involves planning and organizing projects to meet company objectives for design, new process development, and improvement of existing equipment and systems. The position will coordinate with operations, facilities maintenance, laboratory, development, materials management and quality assurance groups.

Primary Responsibilities

  • Develop processes and implement improvements related to new and existing products.
  • Participate in and sometimes lead development activities, experiments, startups, etc.
  • Line coverage in support of manufacturing is common.
  • Daily interaction with the manufacturing group is the norm to understand issues and to communicate plans and instructions.
  • Take initiative to develop and improve procedures and setups through the change control process.
  • Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols, PV Summary Reports.
  • Leads investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
  • Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required. Proactively identify where gaps in SOPs and setups exist and assist and sometimes lead in closing gaps. Problem solving will be routine.
  • Maintains awareness of current developments in the functional discipline. Develops a network of outside contacts such as vendors, consultants, educators and appropriate continuing education courses.
  • Reviews current and new processes; applies state-of-the art technology to our processes.
  • Coordinate line activities with other functions such as maintenance and downstream manufacturing events.
  • Recommend, justify, demonstrates and implements new manufacturing technologies as they become available.
  • Maintains documentation on all projects and submit written reports in a timely fashion.
  • Interfaces with other operating units within and outside the department. Presents ideas and suggestions for product and/or process, equipment improvements, improved Laboratory and Manufacturing operations.
  • Train Manufacturing staff on new processes and/or equipment technologies.

Qualifications

  • B.S. or M.S. in Chemical or Mechanical Engineering
  • 3+ years related experience and/or training; or equivalent combination of education and experience.
  • Knowledge of pharmaceutical parenteral manufacturing and packaging equipment.
  • Good interpersonal and organizational skills.
  • Effective at collaborating with others to obtain the desired organizational objectives.
  • Good listening skills and good oral and written communication skills
  • Requires a high degree of initiative and ability to work with minimal supervision.
  • Able to handle multiple complex tasks and set priorities with multiple internal customers.
  • Supports Technical Services Group with data-based analysis, technical writing and conclusions.
  • Strong working knowledge of MS Excel, Word, and Visio, including formulas and graphing functions.
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Project Manager

Summary

Cross-functional responsibility for facilitating and managing completion of all required elements of the project strategy. This includes elements from Business Development, Research and Development, Manufacturing/Operations, Quality, and Finance. The Project Manager does not complete the tasks, but works in collaboration with the project team and is responsible for assuring that the team members from all disciplines are completing the identified tasks to successfully meet project objective. These responsibilities are carried through product/project lifecycle.

Primary Responsibilities

  • Manage project scope, critical path, timeline and budget of multiple complex projects simultaneously.
  • Manage and communicate client needs and expectations to project team.
  • Coordinate with business development and/or client to ensure appropriate information and materials are provided to facilitate kick-off of project.
  • Create WorkZone Project Tracker for projects and assist with maintenance.
  • Establish practical, achievable, realistic timelines/goals with internal and external project teams.
  • Influence/motivate team members to enact project plans and achieve goals.
  • Identify scope creep and create scope change document with input from appropriate functional groups including business development.
  • Negotiate acceptance of scope changes with client.
  • Effectively schedule, facilitate and manage team meetings and ensure that proper communication regarding the project is appropriately elevated and distributed. 
  • Coordinate with Finance to obtain project financials to hold project close-out meeting.
  • Mentor team members and encourage positive team atmosphere.
  • Develop project risk management plan.
  • Establish and report on essential project metrics (such as variance) and elevate issues/risks to senior and executive management. Manage revenue forecast for projects.
  • Participate in revenue notification process and complete invoice notifications as required.
  • Lead projects in alignment with Coldstream Laboratories Procedures/Policies and FDA guidelines. 
  • Assist in department standardization.
  • Assist in driving WorkZone utilization.
  • Provide WorkZone training to project team members as needed.
  • Other duties may be assigned to meet business needs.

Qualifications

  • Ability to work independently and make sound decisions.
    • Strong understanding of business strategy, finance, and operations management.
    • Good working knowledge of cGMP Guidelines and FDA regulations as well as an ability to understand company policies, SOPs, and Safety/OSHA policies.
    • Proficient in the use of common office software including MS Project (or equivalent alternate PM software), Excel, Word, and Power Point.
    • Sound understanding of project management practices; including project initiating, planning, execution, monitoring/controlling, and closeout.
  • Formal PM training required.
  • At least three years of previous pharmaceutical industry experience required, contract manufacturing or contract research organization experience preferred.
  • At least three years of Project Management experience required.
  • Bachelor’s Degree in applicable scientific field required, advanced degree preferred.
  • Master’s Degree in Business Administration preferred.
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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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