Title: DGM/Sr. Manager - Development Quality Operations

Provide technical and scientific leadership to support upstream processes for early-stage development to ensure seamless handover to commercialization and life-cycle management of Sun’s Branded Portfolio products manufactured internally and by a third-party suppliers/vendors.

• Contribute quality input into CMC strategy and execution to ensure robust supply and advance the company’s portfolio.

• Represent and perform quality oversight duties in process development, characterization, scale-up, validation, tech transfer. Representation at Project Team and CMC meetings to plan for Clinical trial materials and collaborate with teams for handover to Commercial QA and manufacturing

• Provide scientific leadership in functional area to support process, product investigations (including excursions) and troubleshooting.

• Provide technical expertise and leadership to identify opportunities, oversee experimental planning and design, and analyze / trend, interpret, and document development results and review manufacturing data.

• Authoring and review of CMC documentation for regulatory filings. Responsible to support health agency and QP queries and inspections.

• Be an active engaged team member of the Development Quality team, support Management Review, represent Development QA in functional area meetings, as appropriate.

• Other tasks and audits to be performed as assigned by Management.

Qualifications / Educational Requirements

• MS or PhD in chemical/biochemical engineering, biochemistry, or related area with 10+ years of relevant experience.

Skills / Experience Requirements

• Proven record of quality – technical manufacturing experience; ability to influence and drive technical quality rigor; capability for strategic analysis and issue resolution
• Proven ability to work in a fast-paced environment with demonstrated capacity to manage multiple projects, tasks, timelines and demands
• Experience risk-based approaches in decision-making related to development, characterization, and manufacturing of drug products, devices and/or biologics.
• Demonstrate a collaborative teamwork and strong interpersonal skills
• Demonstrated ability to communicate appropriately and effectively
• Demonstrated organizational and project management skills working in a matrix environment.
• Experience performing audits in global regions is a preferred. VISA to travel to US and/or EU countries is a plus.