Job Description

Job Title: Process Chemist

Department: Process R&D

Location: Onsite, Cranbury or South Plainfield Site (NJ)

Job Type: Full Time

Position Reports to: Director of Process Chemistry

Job Summary:

We are seeking a highly motivated and skilled Process Chemist to join our Process R&D Department at Porton J-STAR. In this role, you will be responsible for the development, optimization, and scaling of chemical processes for pharmaceutical production. You will collaborate with cross-functional teams to ensure that our processes are efficient, cost-effective, and compliant with regulatory standards. This job description applies to activities and responsibilities associated with the process chemistry development group and support of GMP Operations.

Responsibilities

Follow existing synthetic routes, making processing improvements where necessary, while conducting multi-step organic synthesis

Plan and organize routine operations to maximize production output.

Design novel synthetic routes and carry out multi-step organic synthesis.

Operate simple open access HPLC/UV, LC/MS, MS, NMR, GC/MS, and other analytical instruments required to monitor reaction processes.

Consult with management, the Analytical Department, the Director of GMP Operations and others on issues concerning experiments prior to and during GMP production.

Accurately make and check calculations, prepare raw materials, reagents and solutions in accordance with company SOP's.

Faithfully record procedures and results in Batch Records or Solution Preparation Forms, notebooks, or other appropriate forms in an organized manner as dictated by departmental SOP and GMP regulations.

Write reports on research as required.

Promote compliance with cGMP regulations. Attend GMP training sessions.

Support management and maintenance of the SOP and Document Control system.

Work with clients to develop material release tests and specifications for materials supplied by J‑STAR.

Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, GMP Operations and Quality Control.

• Conduct process chemistry R&D for clients as an individual contributor, which includes, but is not limited to, research on synthetic routes to active pharmaceutical ingredients and chemical intermediates by route discovery, process optimization, safety evaluation, enabling technologies, high throughput screening and chemo/biocatalytic reaction discovery and optimization. This will include R&D under c-GLP and potentially under c-GMP conditions.
• Develop safe, timely and efficient chemical processes by using established, new and/or novel chemical methodologies and processes.
• Coordinate analytical chemistry methodology to process and/or catalysis discovery, development optimization and problem solving.
• Maintain an uncompromising focus on quality, documentation, confidentiality and scientific execution.
• Participate in idea generation for selective quotes/proposals to clients as well as successfully execute against accepted quotes.
• Initiate cross-department communication and develop coordinated R&D, processing schedules and deliverables
• Lead and contribute to scientific and technical discussions with co-workers and clients to plan, execute, resolve issues and problem solve.
• Communicate candidly, clearly and timely with clients, management and peers.
• Participate in weekly client updates as needed, prepare weekly reports, contribute to and lead campaign reports and participate in process chemistry technology transfer.
• Coordinate and author professional campaign reports, research summaries, and tech packages.
• Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs. Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices.
• Maintain a clean and well-organized hood, bench, glove-box and common work area that is free of clutter, excess chemicals/samples. Advocate for these principals and positively influence others in this regard.

Qualifications

• Required MS, PhD degree in Organic Chemistry.
• Proven track record meeting aggressive targets as related to safe, timely and successful synthetic organic chemistry projects.
• Knowledge and experience base of working in a c-GMP environment is preferable, but not required
• Excellent written, verbal and presentation skills.
• Experience in small molecule drug development is preferable, but not required.
• Track record of scientific success as measured by publications and presentations.
• Ability to prioritize and manage numerous activities simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Experience in working on and positively contributing to scientific teams.
• Ability to perform the physical requirements of the position.

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