Cipla | Manager/Lead - Drug Product - Bengaluru

Accountability Cluster

Leading Drug Product activities

SME of DP for biologics and biosimilars for Process Design, Quality management, and Manufacturing,

Convincing experience in PFS operations

SPOC for service providers and collaborators.

Monitoring progress of the plan with high quality deliverables, provide technical expertise

Providing technical support in device development for biosimilars

Establish robust control strategy of process and its life cycle management

Process Characterization and Process Validation

Designing and execution of Process characterization studies

Overseeing Process Validation studies with manufacturing support

Managing the Product Life cycle management and Drive the external partnerships.

Apply risk management principles and methodologies throughout lifecycle management including FMEA, gap analysis, etc.

Suggest activities in improving the lead times in Product life cycle.

Lead and oversee partnership with DP manufacturing site(s), implementing Control Strategy, Commercial Manufacturing, and Continued Process Verification (CPV).

CMC Regulatory

Develop and refine DP strategies that incorporate best practices and regulatory expectations

Drafting reviewing regulatory sections for dossier submission to various agencies

Provides Documentation support

Draft and review all domain specific documents (protocol reports etc)

Draft and review CTD sections for BLA submission

Review GMP documents

Innovation, Quality

Supporting/overseeing establishment of PFS line at third party service provider

Identify innovative & novel technologies in co-ordination with the suppliers to build future capabilities.

Responsible for supporting and adhering to QMS at Aspergen

Responsible for reviewing GMP QMS elements (deviations, Change controls, OOS etc)

Educational qualifications:

Ph.D. with 6+ years or Masters with 10+ years of relevant industry experience in biologics/bisimilars development for drug product manufacturing

Relevant experience:

Experience in DP development for commercialization including risk assessments, process characterization and validation, experience in biosimilars a plus.

Experience in formulation will be a plus

Extensive knowledge on DP process development and drug delivery for biologics and biosimilars in, pre-filled syringes and devices.

Strong knowledge of regulatory guidelines and practices and experience authoring IND/BLA/MA sections.

Experience in the development of drug-device combination product is a plus

Candidate with experience in shipping validation will be preferred

Candidate requires good understanding of CMC section of BLA submission requirements and expectation from regulatory agency.

Experience in regulatory document writing for dossier submission.

Good communication, writing and technical negotiation skills is must.