Process Safety Engineer
Ash Stevens, with over fifty years as a premier, full-service contract research/cGMP manufacturing organization in the life sciences industry, is seeking a bright, self-motivated, hands-on person of high integrity that will thrive in our growing company’s results driven environment. Overall responsibilities will include activities associated with the manufacture of pharmaceutical products and materials, including chemical process safety evaluations and chemical process scale-up / transfer.
The successful candidate for this position will have solid understanding of chemical processing and the handling chemicals in a manufacturing environment. Knowledge and experience in the pharmaceutical or chemical industries and especially with GMP regulations is desired.
- Responsible for all experiments performed to evaluate process hazards/safety, including the operation and maintenance of the RC-1 and TSU and the safety-specific operation of the DSC.
- Perform laboratory hazard evaluations to support the development and scale-up of safe chemical processes.
- Participate in project hazard evaluation meetings to evaluate process hazards and communicate and evaluate pertinent safety testing results.
- Interact with third-party vendors for the completion of safety testing using equipment (ARC) not available onsite
- Conduct experiments and engineering evaluations to facilitate the scale-up and transfer of processes from laboratory to plant equipment.
- This may include crystallization experiments (EasyMax® with FBRM/PVM) to control polymorph and particle size distribution (PSD), design of experiments (DoEs) to identify critical process parameters, and specific unit operation modeling
- As PD representative, actively participate in the formal transfer of processes from PD to the plant.
- Plant production of all development projects/approved projects until successful tech transfer to Operations.
- Perform evaluations on potential new projects to assess safety, scalability, cost, and timing to support the preparation of a project proposal.
- Coordinate efforts with EH&S to improve day-to-day operations and contribute to improvements in PPE and engineering controls with the goal of minimizing operator exposure.
- Manage and conduct the process development of current and new synthetic/process pathways.
- Ensure that adequate supplies of process materials (raw materials, solvents, reagents, etc.) and operation equipment (testing supplies, hoses, reactors, glassware, etc.) are available for assigned tasks.
- Write progress reports and provide technical support in meetings, regarding safety/engineering evaluations and also current API production/new API process development.
- BS Degree in Chemical Engineering
- Minimum 3 years’ experience in the Pharmaceutical Industry
- Expertise in laboratory hazard evaluations of chemicals and chemical processes
- Expertise in engineering evaluations to support process scale-up
- A good understanding of organic chemistry and chemical safety
- The ability to manage projects with associated timelines
- A familiarity with cGMP requirements, and with plant safety and EPA requirements
- The ability to interact effectively with ASI personnel
- Project Management (Estimate Project costs and Timelines)
- Evaluate current processes with respect to safety, efficiency and improvement
- Provide technical support for chemical development scientists, quality control, etc.
- Ensure that product / sample shipments meet customer and regulatory (FDA, EPA, OSHA, etc.) requirements
- Ensure that approved processes are carried out according to cGMP guidelines and are properly documented
- Ensure that quality control and quality assurance are informed and kept up-to-date with regards to project/clients requirements and schedules
- Provide accurate inventories of materials, as needed
Compensation commensurate with experience and ability. Excellent benefits package.
If interested, please send a MS Word version of your resume to email@example.com
Regulatory Affairs Associate
Primary function of the Regulatory Affairs Associate is to serve as a regulatory liaison to clients and internal functional departments.
Assists in the implementation, execution and maintenance of quality systems to ensure Ash Stevens complies with regulatory requirements as propagated by the United States Food and Drug Administration (FDA) and similar international regulatory bodies. Principal assignments related to compliance will include writing documents, review of records and data, review and implementation of new or revised documentation to ensure that ASI drug regulatory requirements are met.
Participate in outside meetings, forums, etc. to ensure the latest thinking is applied to Regulatory and Chemistry, Manufacturing and Controls (CMC) strategies.
As talents and experience dictate, the Associate will interact with auditors from regulatory bodies and clients.
KEY DUTIES AND RESPONSIBILITIES:
1). Document Preparation and Review - 60%
Assist in the writing, preparation and/or review of documents to ensure compliance with FDA requirements, quality agreements and regulations.
Accurately authors and assembles documentation for client regulatory submissions. Reviews proposed product changes for impact on regulatory status of the product and provides regulatory guidance and support for development and production activities.
Partner with internal and external customers to assemble and review data in support of annual regulatory filings and in support of the preparation of the CMC portions of INDs, DMFs and NDAs, amendments and supplements.
Support maintenance of regulatory reporting schedules.
Assist in document record maintenance and destruction in accordance with SOPs.
Provide other regulatory and quality assurance support as needed to colleagues within ASI.
2). Reports - 20%
The Associate will assist in the development and preparation of regulatory reports for the file or for submission to regulatory bodies. In addition, the Associate will participate in the preparation or review of associated documentation, such as, Cleaning Validation Reports and Process Performance Qualification Protocols and Reports.
3). Continuous Learning - 10%
Maintain current knowledge of FDA and other pertinent Health Authority regulations for effective regulatory submissions. Remain current on FDA updates including new policies and guidances.
4). Meetings with customers and investigators - 10%
Participate in discussions with customers and investigators.
Education and Experience:
- Minimum Bachelor’s degree in science, chemistry or chemical engineering degree is preferred.
- 2-4 years’ experience in regulatory affairs or related field in pharmaceutical manufacturing preferred
- Experience with the application of Design Of Experiment (DOE) and Quality by Design (QbD) a plus.
- Knowledge of GMP requirements (21 CFR Part 211 and/or ICH Q7a)
- Knowledge of Drug Regulatory requirements, specifically as relates to preparation of
- CMCs, DMFs or CTDs.
This position is intended as a mid-level position. As the individual develops an understanding of internal and external requirements, opportunities for growth are available.
Essential Skills and Abilities
- The successful candidate should have good organizational and planning skills
- The successful candidate should have strong written, verbal and interpersonal communication skills.
- The successful candidate should possess effective skills for developing, performing, evaluating, troubleshooting within a scientific/technical discipline.
- RAC and/or related professional certifications or willingness to obtain such certification is preferred.
Physical Requirements/Work Environment
- Must be able to lift/push/pull up to 30 pounds occasionally
- Ability to work on a computer the majority of the day
- Potential limited exposure to hazardous chemicals
- Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
Applicants must be authorized to work in the US for any employer without visa sponsorship.
Please send resumes to:
Ash Stevens Inc.
18655 Krause St.
Riverview, MI 48193