Analytical R&D Scientist
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
- 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.
Experience, Education and Licensure
- 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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The role of the manufacturign 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.
- 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.
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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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.
- 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.
- 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.
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Instrumentation and Controls Technician
The role of the Instrumentation and Controls Technician is to provide the necessary knowledge and skill sets needed to properly and efficiently calibrate, maintain, troubleshoot and repair Coldstream Laboratories, Inc. GMP process, facility, and laboratory equipment and instrumentation. This position is also responsible for working across departments to coordinate the timely completion of routine and non-routine calibration and the maintenance, documentation of all activities per the required procedures and processes.
- Under guidance of the Facilities Engineering Manager, primarily responsible for performing routine and non-routine calibration of CLI's critical, non-critical, and safety related instruments used to support GMP process manufacturing, packaging, facility and other material testing processes.
- CLI's GMP process manufacturing equipment includes but is not limited to an autoclave, depyrogenation oven, lyophilizer, parts washer, vial washer, Water for Injection and Purified Water System, and other misc process support equipment. CLI's laboratory equipment includes but is not limited to temperature and humidity controlled stability chambers and chart recorders, timers, and temperature indicators.
- Must maintain a high level of instrumentation and controls knowledge, skills and experience in order to thoroughly assess any problems with the equipment and systems, identify the problems, make the necessary repairs and then complete all associated GMP documentation needed to appropriately document the work performed (e.g. work orders, change controls, etc).
- A high level of knowledge and skill utilizing tools such as multimeters, temperature measuring standards, humidity measuring standards, pressure standards, etc. is required.
- Possess personnel skills needed to work across CLI's departments (and associated department management) to coordinate routine and non-routine activities within the master production schedule, work closely with Operations personnel to obtain information needed to assess equipment problems in a courteous / professional demeanor, as well as coordinate and oversee the work of vendor technical personnel.
- Assist in establishing and maintaining any necessary procedures and processes required to perform routine calibration equipment and systems throughout the plant. This includes but is not limited to establishing calibration procedures / tasks, establishing and maintaining appropriate calibration schedules and intervals, reviewing / enhancing calibration procedures when required and identifying improvements to existing calibration processes in order to ensure peak performance of the process equipment.
- Will also be required to participate in cross functional teams that may be required to identify assignable root causes for any product or equipment related deviations or anomalies, and then establish and implement the necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future.
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