DifGen Pharmaceuticals

Associate Director, Commercial Tech Lead

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  20 days ago
Apply
AI can make mistakes so check important info. Chat history is never stored.
46
AI Success™

Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
Job Shift: Day
- Lead Commercial batch manufacturing and technology Transfer activities to internal and external (CMO) manufacturing sites for solid orals, liquids, softgel, parenteral and semisolid dosage forms.
- Drive CMO selection based on technical capabilities, capacity, regulatory compliance, and project feasibility.
- Plan and execute site readiness, including audit preparation, gap assessment, and technical capability mapping.
- Review and finalize regulatory submission documents (Module 3 – CMC) and provide timely responses to agency queries in coordination with Regulatory Affairs.
- Define and oversee batch execution strategy, including scale-up, validation and commercial batches.
- Monitor and guide the preparation and review of key documents including CBMRs, validation protocols, and technical reports.
- Coordinate with cross-functional stakeholders –Project Management, R&D, QA, QC, Regulatory, SCM, and Manufacturing – for seamless knowledge transfer and project execution.
- Act as a single point of contact for technical discussions with internal teams and CMOs.
- Identify and resolve process challenges during scale-up and commercial execution, ensuring timely issue resolution and continuous supply as per market forecast.
- Support regulatory inspections, customer audits, and internal quality audits at CMO or in-house facilities.
- Mentor and supervise team members to build functional expertise and ensure high performance.
QualificationM. Pharma with around 15-17 years of expertise in execution of commercial batch manufacturing, with regulatory compliance
DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
Social Media