Chemist - Analytical Development

Overview

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world‑class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world.

Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much‑needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, and our responsibility, to make our success and our customers’ success more certain.

Provides analytical and technical support to CDMO product development and technology transfer in a high‑pace flexible environment. Completes method development, validations, USP/NF method verification, method transfers, and various laboratory support functions. Provides essential analytical support to various projects, ensuring revenue growth, lab capability enhancement, and quality compliance. Provides effective communication to the analytical team and applicable cross‑functional groups to ensure proper coordination of program management.

Provides coaching and mentoring to junior chemists.

• Responsible for development and validation of assigned analytical methods such as assay and impurities/degradation products, residual solvents, content/blend uniformity and dissolutions.
• Author method development reports, method validation protocols/reports, and method transfer protocols/reports.
• Execute method validation/transfer testing.
• Develop robust methods that are time‑tested in a routine quality control environment.
• Lead method troubleshooting and rectifies challenges effectively using a variety of techniques including advanced principles and concepts.
• Assess incoming methods from clients and ensure compliance with current applicable guidance’s and BPI internal practice/procedures.
• Ensure robust method transfer strategy to ensure adequate method performance at BPI (or receiving lab).
• Read, understand, and follow the current USP/NF, laboratory SOPs, analytical methods and study protocols.
• Apply applicable ICH and FDA guidelines to analytical method development, validations, and transfers.
• Assist with establishing specifications for APIs and drug products and assist with justification of these specifications to be included in regulatory submissions.
• Document equipment usages and analytical results in a manner that is consistent with cGMP, in‑house SOPs, and can be readily followed by reviewers.
• Proactively identify, communicate, and escalate risks or issues to laboratory management and cross‑functional teams to minimize project impact.
• Review raw data timely and ensure it meets cGMPs and in‑house SOPs, is scientifically sound and can be readily followed by auditors.
• Show expertise with analytical instruments such as HPLCs, GCs, dissolution apparatus, and other analytical equipment.
• Actively solve instrumentation issues and assist others with instrumentation startup and troubleshooting.
• Maintain personal and shared workspace in an organized manner; clean laboratory glassware and participate in lab‑wide routine clean‑up and inspection activities.
• Identify potential training, efficiency, compliance and/or safety concerns and bring solutions to management.
• Actively participate in and lead the implementation of continuous improvement efforts associated with laboratory operation.
• Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide coaching and mentoring to junior chemists.

• A Bachelor's Degree in Chemistry or related field with 12 credits of college chemistry and 6 years analytical experience, preferably in the pharmaceutical industry.
• OR, a MS degree with a minimum of 4 years’ experience.
• OR, a Ph.D. with a minimum of 1 year experience in analytical method development in a drug product pharmaceutical industry.
• Knowledge of analytical chemistry, strong verbal…