Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
At Thermo Fisher Scientific Inc., we provide an outstanding opportunity for a passionate Staff Scientist in Process Development. You will be at the forefront of crafting and implementing innovative scientific methodologies to manufacture and control raw materials, production intermediates, and final products. Engage in ambitious projects across development, pre-clinical, and early clinical stages of drug development. Your role will involve developing flawless processes and equipment designs for various demonstration and production batches, including technology transfers. Collaborate and innovate with a multidisciplinary team to successfully implement strategies that fulfill client needs and expectations.
Crucial Requirements:
Develop feasible chemical processes to synthesize drug intermediates and APIs that meet or exceed client quality requirements.
Collect and detail reliable process data through crafted laboratory experiments.
Analyze scientific data and summarize findings to draw logical conclusions; write technical reports and participate in technical discussions.
Proficient in analytical techniques such as NMR, IR, UV, HPLC, GC, and MS for compound identification and structure elucidation.
Prepare detailed process development reports to support manufacturing and regulatory needs.
Draft and review Operating Instructions, Deviations, Change Controls, and Investigative documentation.
Complete laboratory scale production following SOP/cGMP guidelines.
Lead process technology transfers and provide technical support for scale-up production.
Manage process development timelines and activities with minimal direction.
Exhibit excellent interpersonal skills and fit within a multidisciplinary team.
Education:
PhD in Chemistry or equivalent experience required, with a preference for Organic Chemistry.
Experience:
3+ years of relevant scientific experience, with pharmaceutical industry experience and/or post-doctoral experience preferred.
Strong project management and process development experience is highly desirable.
Physical Requirements:
Ability to stand, walk, stoop, kneel, crouch periodically, and manipulate light to medium weights (10-35 pounds).
Dexterity for prolonged keyboard use; visual acuity for computer monitor use.
Ability to sit, reach, talk, and hear for prolonged periods.
Required to use safety glasses, shoes, lab coat, gloves, apron, and organic respirator when necessary.
Disclaimer Statement: "The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an extensive list of all responsibilities, duties, and skills required of personnel so classified."
