Job Description

Job Description

Essential Duties and Responsibilities

NOTE: The preferred academic qualification for this role is a PhD. We will consider H1B transfer for this role. Candidates MUST have at least 5-6 years of pharmaceutical industry experience to be considered.

• Conduct standard and advanced laboratory activities independently including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
• Execute approved method transfer protocols, develop and validate analytical methods
• 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 submission documents independently. Design experimental studies and write reports with minimal supervision.
• Independently conduct manufacturing activities for inhalation drug products.
• Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of experimental design.
• 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.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate Health & Safety rules and procedures.
• Comply with all Corporate guidelines and policies.

Qualification Requirements

• Sr. Scientist 1- PhD in Chemistry or Pharmacy or related fields with at least 6 years ; MSc with at least 8 years or BSc with at least 11 years of experience in pharmaceutical or related fields.
• Sr. Scientist 11- PhD in Chemistry or Pharmacy or related fields with at least 8 years ; MSc with at least 10 years or BSc with at least 14 years of experience in pharmaceutical or related fields.
• Experience in aerosol sciences preferred.
• Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or broad knowledge of development and manufacturing of inhalation drug products.
• Knowledge and broad understanding of FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH guidelines.
• Strong English language skills including writing ability and oral communication

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