Has operational end-to-end responsibility within the Local Supply Center for material supply of the assigned projects. Represents the Supply Center in CHAD and PHAD project subteams. Influence process development by providing expertise in scaling up the chemical processes in order to develop mature and robust processes and prepares and execute launches at TechOps when appropriate.

Major accountabilities:

•Represent LSC in CHAD and PHAD project subteams and serve as the main contact between the CDU and LSC for the assigned projects.

•Operational end-to-end responsibility for material supply of the assigned projects within LSC.

•Work frequently on several projects simultaneously.

•Plan, prepare and execute assigned process steps/campaigns within the Supply Center according to iDevGuide and internal regulations (GMP and HSE) while meeting project team targets:

a. Prepare synchronization of synthesis & cost estimation for assigned campaigns

b. Determine suitability and availability of appropriate process equipment and suggest modifications as needed.

c. Early identification of processing hurdles and safety concerns and suggests alternatives.

d. Evaluate suppliers in collaboration with project team and place purchase orders for raw materials as appropriate.

e. Initiate and monitor progress at external suppliers in the case of outsourced material supplies.

f. Monitor the progress of process development in mitigating the identified processing and safety risks.

g. Write Plant Master Procedures.

h. Prepare required air emissions forms as appropriate.

i. Attend and evaluate safety assessment of lab and plant processes (DERA) for assigned steps.

j. Train manufacturing team on processes based on PMP.

k. Be available to provide guidance to the manufacturing team during their batch execution of your process.

l. Be present on the plant floor when critical process steps are performed.

m. Troubleshoot process as appropriate and assess potential impact of any process deviation and intended changes for future batches.

n. Perform internal BRR and get QA approval of the BR.

o. Establish appropriate campaign documentation (campaign experience report, cost estimation, production scenarios, registration documentation etc.).

•Actively contribute to process development by providing expertise in scaling up the chemical processes in order to develop mature and robust processes.

•Prepare and execute launches and validation campaigns at TechOps and give on-site support as assigned.

•Represents Supply Center in project specific approval audits by authorities (e.g. PAI)

•Participate in assigned non-project related activities within Supply Center, such as:

a. Lead and execute business process improvements initiatives within Supply Center

b. Collaborate in cross-functional working parties.

c. Implement new regulations, policies.

d. Write SOPs and EOP’s.

e. Collaborate on capital investment projects.

f. Train Operational Staff on EOP’s and SOP’s authored.

g. Mentor Flexible Work Force and inexperienced Process Chemists.

•Various responsibilities in accordance to GMP & HSE responsibility lists/Team Matrix List of the LSC.

.

Minimum Requirements:

•Advanced degree in science, engineering or equivalent.

•Fluent in English, local language desired.

•3 to 4 years of practical experience in chemical / pharmaceutical industry or > 4 years of experience in field of expertise.

•Recognized expertise in related field. Good (IT) application know how.

•Good knowledge about the Drug Development process.

•Comprehensive knowledge about project management.

•Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.

•Demonstrates cross-functional problem-solving and idea generation skills.

•Advanced presentation skills. Good leadership skills.

•Excellent organization and planning skills. Ability to work in interdisciplinary and cross-cultural teams

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Materials Science

Process Simulation

Sop (Standard Operating Procedure)

Manufacturing Process

Experiments Design

Environment

Laboratory Equipment

Coaching Skills

Health And Safety (Ehs)

Technical Writing

Data Science

Waterfall Model