The R&D Technical Writer position will report to the Senior Director of Downstream R&D. The successful candidate will serve as a technical team member and will support the drafting technical documents and development reports consistent with the project schedule.

• Prepares written project documents, including reports, memoranda, and SOPs.
• Author and create submission content from source documentation for registrations and provide writing support for technical reports.
• Use experience in Process Development to identify technical inconsistencies and participate in resolution.
• Strong written and oral communication skills to summarize studies from reports, presentations, and notebooks and a demonstrated ability to document information in a clear and concise manner.

• Bachelor degree in chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field required.
• 3 or more years of relevant experience required.
• Demonstrated knowledge of pharmaceutical manufacturing and process development
• Knowledge of product lifecycle - Product and process development, validation, regulatory submissions, and commercial GMP manufacturing.
• Demonstrated experience working with Microsoft Office programs (Excel, Word, Power Point, Visio, etc.).
• Behavioral requirements for success in this position include self-starter, strong work ethic, excellent written and verbal communication skills.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.