Senior Formulation Scientist

Lupin; Florida; On-site; USD 120,000 - 180,000; Full time

Job summary

Lupin is seeking a senior formulation scientist in Florida to lead pre-formulation and formulation research for inhaled products. You will design studies, evaluate raw materials, and develop advanced formulations for MDIs, DPIs, and solutions, following cGMP guidelines.

The role requires a PhD or equivalent with extensive hands-on experience, strong data analysis and writing skills, and the ability to mentor junior staff while coordinating with cross-functional teams.

Qualifications

• PhD/MS/BS with extensive pre-formulation and formulation research experience in pharma.
• Hands-on experience with typical formulation and processing equipment.
• Knowledge of FDA cGMP requirements and USP/ICH guidelines.
• Strong English writing and verbal communication skills.

Responsibilities

• Independently conduct standard and advanced laboratory activities, including evaluation of raw materials.
• Prepare and maintain accurate lab records; analyze data and identify trends.
• Write protocols, SOPs, and contribute to submission documents with minimal supervision.
• Design studies and support project timelines; mentor junior staff.
• Support manufacturing activities for DPI/MDI/nebulaer products and troubleshoot issues.

Skills

Pre-formulation research

Formulation development

Data analysis

Technical writing

Education

PhD in Pharmaceutics/Pharmaceutical Chemistry/Analytical Chemistry

MS with 10+ years experience

BS with 15+ years experience

Job description

Independently conducts standard and advanced laboratory activities including evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material etc.); pre-formulation and formulation development studies for solutions, suspensions, bulk and formulated powder and propellant based formulations for orally inhaled products following cGMP, Lupin EH&S and other relevant guidelines. Develops and evaluates new formulation technologies where required.

Essential Duties and Responsibilities

• Independently set up and operate laboratory equipment, conduct instrument troubleshooting.
• Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform statistical analysis.
• Write protocols, methods, standard operation procedures, and contribute to submission documents independently. Design experimental studies and write reports with minimal supervision.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups. Lead broad project tasks effectively, with minimal supervision.
• Independently design studies and conduct evaluation and selection of raw material (APIs, excipients, primary and secondary packaging material, device component material etc.).
• Independently design studies and conduct pre-formulation and formulation development studies for solutions, suspensions, emulsions, bulk and formulated powders, propellant driven formulations for metered dose inhalers (MDIs).
• Support manufacturing activities including powder blending and troubleshoot technical issues during manufacture of Dry Powder Inhaler (DPI), Metered Dose Inhaler (MDI) and nebulizer drug products.
• Independently investigate and recommend corrective actions for deviations, out-of-specification and out-of-trend results.
• Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of process technologies and experimental design.
• Coach, train and support junior laboratory staff. Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; assure compliance to Lupin Quality procedures and follow Lupin safety rules and procedures. Comply with all Lupin Corporate guidelines and policies.

Qualification and Experience

• PhD in Pharmaceutics/Pharmaceutical Chemistry/Analytical Chemistry or related discipline with 5+ years, MS with 10+years, or BS with a minimum of 15+ years pre-formulation and formulation research experience in the pharmaceutical field.
• Must have hands-on experience with typical formulation and processing equipment. Experience with pre-formulation and formulation research would be preferred.
• Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Excellent understanding of USP methodologies and ICH guidelines.
• Strong English language skills including writing ability and oral communication.

Customer Centricity

Developing Talent

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

Connect With Us

Follow our social channels to get a
glimpse of life at Lupin