Analytical Development

Essential Duties and Responsibilities

- Design, develop, and implement analytical methods for the characterization.
- Establish robust control strategies through identification and characterization of Critical Quality Attributes (CQAs), development of analytical methods through assay validation, design and execution of stability studies
- Supervise and mentor other analytical scientists driving qualified growth of group members
- Contribute to authoring of regulatory submissions, including pre-submission briefing books, clinical trial applications, and responses to agency questions
- Provide technical oversight of method development/transfer and QC testing at external vendors
- Effectively interface with other functions including Quality, Regulatory, Research, Nonclinical and Clinical Development and other CMC functions (Process Development)
- Participate in quality events (OOS, OOT, laboratory investigations, CAPA, CC) as needed
- Implement technical solutions using strong problem-solving skills across multiple projects
- Demonstrate strong written and verbal communication skillsQualifications

Required:

- PhD in Analytical Chemistry, Biochemistry, Chemistry,



or related field and 6+ years of experience working in Pharma or biotech, or equivalent combination of education and experience
- Experience with regulatory submissions including pre-submission meeting briefs, Common Technology Document (CTD) authoring and Response to Questions (RtQ) Preferred:
- Experience with analytical control strategy development from pre-FHD to commercial launch
- Experience with the development of gene therapies, cell therapies, or biologics
- Knowledge of multiple analytical techniques applicable to gene therapy products, such as ddPCR, next generation sequencing (NGS), capillary electrophoresis, UPLC, cell-based potency and ELISAs
- Ability to adapt to evolving project needs and prioritize multiple activities
- Demonstrated proficiency with the implementation of analytical Quality by Design (QbD) principles

Job Types: Full-time, Permanent

Perks:

- Paid sick time
- Paid time off

Ability to commute/relocate:

- Gota, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Experience:

- pharmaceutical quality control (OSD): 7 years (Required)

Work Location: In person

📌 Analytical development Manager (India)
🏢 BKM Health
📍 India