Scientist II Analytical

Summary:

Join this innovative team and fast growing Biotech dedicated to advancing pharmaceutical research and development. Seeking a motivated and skilled Scientist with experience developing analytical methods for small molecule drug products to contribute to 2025 milestones.

Key Responsibilities:

• Conduct laboratory activities & lead projects with minimal supervision, including analyzing raw materials, in-process materials, and finished pharmaceutical products for quality, safety, purity, strength, and identity.
• Independently set up and operate lab equipment, prepare reagents, solvents, and solutions for analytical and formulation activities.
• Maintain accurate records in lab notebooks and process analytical data using lab equipment such as HPLC/UPLC.
• Support the manufacture of small molecule drug products and prepare samples for blend uniformity.
• Perform equipment qualification and calibrations as directed.
• Execute approved method transfer protocols.
• Assist in training other scientists and perform additional tasks as assigned.
• Participate in project activities, support project timelines, and contribute to team objectives.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs, following corporate safety rules and procedures.
• Comply with all corporate guidelines and policies.

Qualifications:

• Masters in Chemistry, Pharmacy, or related fields with at least 6-8 years of industry experience, or Ph.D. with 2-3 years of experience in the Pharmaceutical industry.
• Proven ability and/or experience with compendial test methods or pharmaceutical manufacturing equipment.
• Understanding of pharmaceutical equipment and computerized systems for operation and troubleshooting.
• Specific experience with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender, etc.
• Experience with Empower software
• Knowledge and understanding of FDA cGMP requirements as they apply to the pharmaceutical industry.
• Effective English written and oral communication skills, with the ability to write short technical documents such as memos, laboratory investigations, protocols, and reports.