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MS&T Technical Manager

MS&T Technical Manager

NOVARTIS

5 - 10 years

30 - 35 Lacs

hyderabad

Posted:10 hours ago| Platform:

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Skills Required

product launch automation iso manufacturing process analytical manager technology continuous improvement project team lead monitoring process management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Leads a cross functional team for product transfers/launches to 3rd parties (process,
technology, analytics, capacity, resources).

Ensures appropriate project management to achieve milestones in time, with required quality
and in budget by leading the respective technical sub-team and liaising efficiently with related functions.

Provides technical expertise together with manufacturing experts.

Supports CMO site selection and ensure right technical fit for transfer/launch

Defines and monitors technical project scope, timing and progress in collaboration with Giving
Site or TRD

Writes Manufacturing Process Transfer Documents (protocol, report).

Coordinates feasibility, regulatory and validation batches at site.

Initiates monitoring and Continued Process Verification CPV phase.

Ensures that all activities are performed to current standards (current Good Manufacturing
Practices cGMP, Health Safety Environment HSE, Regulatory etc.).

Supports continuous process and quality improvements.

Supports QA to ensure inspection readiness (Pre Approval Inspection PAI).

Essential Requirements:

Technical transfer milestones achieved on time and in full, including schedule for registration and launches.
Robust manufacturing process at CMO, delivering critical quality attributes.
Analytical methods in place, meeting cGMP standards.
No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI).
Adheres to project / Capital Approval Request CAR costs.

Recognized as an excellent collaborator and partner by the CMOs, SRTs, QA and others partner functions (R&D)
When acting as Product Steward, meet related KPIs:
Product is maintained in constant state of validation.
Product history is documented and available and current since transfer from development/transfer to CMO to date.
Recurring Deviations.
Continuously improving CpK process capability.
Degree of standardization of product process
OoS, OoE Out of Specification, Out of Expectation.
Customer Complaints.
Recalls.
Success rate of Health Authorities inspections.
Completeness of Reg CMC dossier
Effective CAPA.
Continuously improving Yield.
Technical reports executed on time and with the right expectations

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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MS&T Technical Manager