Senior Process Engineer

The Senior Process Engineer develops, configures and optimizes industrial processes from inception through to start up and certification. Assesses processes, takes measures and interprets data. Designing, running, testing and upgrading systems and processes.

RESPONSIBILITIES  

• Create and execute protocols for Scale up, Optimization Studies, Process Validation and Cleaning Validation. Develop all documentation for process validations including IQ, OQ, and PQ protocols as well as risk assessments.
• Create Manufacturing Batch Records for developmental, clinical, registration and commercial products.
• Create/revise existing/new SOP’s for equipment and processes.
• Lead/support technology transfer projects.  This includes working directly with R&D teams/personnel for the transfer of data, processes and technical specifications for implementation into large scale manufacturing operations.
• Analyze data, present/write technical reports and develop design of experiments for new product implementation.
• Investigate opportunities for improvement within departments looking specifically to increase accuracy and efficiency.  This will encompass workflow evaluations as well as equipment evaluations.
• Provide technical assistance/expertise to maintenance and operations personnel on equipment troubleshooting and repairs.
• Assist in training Manufacturing personnel.
• Author manufacturing deviations and CAPA.
• Assist in creation of technical risk assessments.
• Perform process capability analysis on production processes.
• Implement Lean Manufacturing Principles in Production area.
• Assist in gap analysis, FMEA and/or risk assessments to ensure evaluation of critical systems and equipment comply with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Interacts with the regulatory officials to convey the compliance level of the equipment and facility during regulatory inspections.
• Strong problem solving, technical writing and statistical analysis skills.
• Exhibits strong process and equipment design skills.
• Manages projects to deliver results on time and on budget.
• Proficient in Process Safety concepts and methodology.
• Proficient in Commissioning and Validation strategies and execution.
• Focused on Meeting Customer Needs.
• Ability to communicate clearly with colleagues and clients in both written and verbal form.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• Must have 10+ years Pharmaceutical experience, preferably in a process engineering role.
• Must have experience in solid dose formulations.
• cGMP and validation experience preferred.

EDUCATION REQUIREMENT

• BS degree in Engineering or Sciences.

Buyer/Planner

Job Type: Full-time

• Work closely with project managers and clients to establish required specifications for manufacturing materials from approved vendors and ensure sourced materials are available when required
• Ensure materials are sampled by Quality Control and tested per the approved specifications
• Work closely with the Quality Unit to ensure results for material testing are completed and submitted for approval in order to release for use in manufacturing
• Support projects by locating sources and completing purchase orders as per the established internal processes and procedures.
• Assist Purchasing with vendor management; factoring in costs, customer service, availability of materials and assessing the reliability
• Ensure requirements for operations and the partners/clients are met
• Support DEA controlled substance handling; work closely with Quality Unit to issue inventory control numbers, manage controlled substance ARCOS reporting and controlled substance inventory maintenance
• Maintain inventory database for materials for manufacturing
• Familiarity with sourcing and vendor management
• Exhibit an ability for negotiation and establishing good business relationships with vendors
• Partner with stakeholders to ensure clear requirements documentation
• Assess, manage and mitigate risks
• Determine the quantity and timing of deliveries
• Assist in monitoring and forecasting upcoming levels of demand vs inventory
• Other duties as assigned by Management

MINIMUM REQUIREMENTS

• 1-2 years’ experience in customer service / technical support (preferably in the pharmaceutical industry)
• 1-2 years of procurement experience required.
• The Projects Logistics Associate should demonstrate competence in all of the following:
• Behave Ethically: Understand ethical behavior and business practices, and ensure that their own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
• Communicate Effectively: Speak, listen, and write in a clear, thorough, and timely manner using appropriate and effective communication tools and techniques.
• Creativity/Innovation: Develop new and unique ways to improve operations of the organization and to create new opportunities.

EDUCATION REQUIREMENTS

• Bachelor’s Degree

PHYSICAL DEMANDS

• None (other than normal office environment requirements)

Project Manager

Job Type: Full-time

Accomplishes project objectives by planning and evaluating project activities.

RESPONSIBILITIES

• Create a detailed work plan which identifies and sequences the activities needed to successfully complete the project.
• Determine the resources (time, money, equipment, etc.) required to complete the project
• Develop a schedule for project completion.
• Review the project schedule with senior management and all other staff that will be affected by the project activities; revise the schedule as required.
• Determine the objectives and measures upon which the project will be evaluated at its completion.
• Execute the project according to the project plan.
• Develop forms and records to document project activities.
• Set up files to ensure that all project information is appropriately documented and secured.
• Monitor the progress of the project and adjust as necessary to ensure the successful completion of the project.
• Establish a communication schedule to update stakeholders including appropriate staff in the organization on the progress of the project.

The Project Manager should demonstrate competence in some or all of the following:

• Behave Ethically: Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
• Communicate Effectively: Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.
• Creativity/Innovation: Develop new and unique ways to improve operations of the organization and to create new opportunities.
• Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve problem, and make decisions that enhance organizational effectiveness.
• Lead: Positively influence others to achieve results that are in the best interest of the organization.
• Make Decisions: Assess situations to determine the importance, urgency and risks, and make clear decisions which are timely and in the best interests of the organization.
• Organize: Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
• Plan: Determine strategies to move the organization forward, set goals, create and implement actions plans, and evaluate the process and results.
• Solve Problems: Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem.

WORK EXPERIENCE REQUIREMENTS

• 3 years’ experience in Project Management role or similar (preferably in the pharmaceutical or technical industry).

EDUCATION REQUIREMENTS

• Bachelor’s Degree (Preferably in a Science or Technical Field)

Notification to Agencies:

Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.

Senior R&D Scientist

Job Type: Full-time

The Senior Scientist will be responsible for performing all essential functions of Analytical Chemist III, as well as:

• Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences; ability to make autonomous decisions regarding day to day activities.
• Demonstrates ability to independently manage design/development, optimization, validation and transfer of analytical methods in support of Drug Substances and Drug products.
• Provides analytical services to manufacturing, process development, validation, new material and critical reagent qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, and regulatory requirements.
• Analysis of finished products, in-process materials, raw materials, and cleaning verification/validation samples according to the assigned specifications, methods and protocols. Analytical instrumentation may include, but is not limited to HPLC, GC, TOC Analyzer and Spectrophotometer.
• Demonstrates ability to prioritize assignments; time management and multitasking in a dynamic environment.
• Documents all experiments and results thoroughly with detailed observations.
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies and goals.
• Critically assesses experimental data and provides interpretation of results, including statistical analysis.
• Prepares technical reports, summaries and protocols.
• Utilizes independent action and decision making with follow-up reporting to supervision.
• Directs and executes experiments of a scientifically complex nature.
• Demonstrates ability to interact effectively within department team, mentoring and training unit personnel as needed.
• Appreciates and values different perspectives. By example, often motivates co-workers and peers to perform their best work.
• Evidence of effective communication, both verbally and written, highly organized, analytical, accurate, and detail-oriented.
• Demonstrates ability to work successfully in a highly collaborative, team oriented, customer focused environment.
• Responsible for the preparation of robust processes that lead to the development of new technologies that support specific client platforms.
• Provide support for operations and other process support teams by providing scientifically sound recommendations, improving efficiency, meeting of timelines, and the development of successful processes while operating in compliance with cGMP regulations, and company SOPs.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• Minimum of 5 years’ experience with identification or separation techniques such as HPLC, UPLC, GC, and experience with method development and/or validation

EDUCATION REQUIREMENTS

• Doctorate in scientific field with 3-years’ experience, or
• MS in scientific field with 5-years’ experience, or
• BS in scientific field with 10-years’ experience in an analytical environment

PHYSICAL DEMANDS

• Able to stand, sit for long periods of time.
• Able to read, write, speak and comprehend the English language.

Notification to Agencies:

Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.

Analytical R&D Chemist III

Job Type: Full-time

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people, team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus and ethical Behavior.

The Analytical Chemist III also performs all essential job functions of Analytical Chemist I and II.

Job description:

• Designs, executes, and interprets complex procedures and protocols within a project or goal, subject to approval of supervisor.
• Trains and directs lower level personnel.
• Writes SOP’s and protocols.
• Reduces literature references to practice.
• Works independently on execution of complex procedures and methods
• Demonstrates ability to accurately record and review laboratory documentation generated from developmental as well as established procedures.
• Influences purchase of laboratory supplies as well as capital equipment.
• Suggests alterations to procedures and protocols and studies. Compliant with safety and hazardous waste procedures.
• Participates in moderate to extensive problem solving which requires original thought. Prepares reports with interpretation and can interpret the results of complex experiments.
• Non-routine assignments. Designs experiments when requested. Handles major portion of project activity with supervision.
• Performs routine as well as more complex assays and preparations.
• Troubleshoots equipment, laboratory protocols and procedures.
• Participates in audits for regulatory requirements.
• Treats data with a high level of integrity and ethics.
• Conscientious with safety procedures and knowledgeable of hazardous waste procedures.
• Performs other related duties as assigned by management.

WORK EXPERIENCE

• 4 years’ experience in a professional GMP pharmaceutical lab setting.
• HPLC and wet chemistry experience required.
• Must be fluent in English. (speaking, reading and writing)

EDUCATION

• Minimum BS/BA with a science or chemistry and biology background.

PHYSICAL DEMANDS:

Able to stand and/or sit for long periods of time.

Notification to Agencies:

Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.