Manufacturing Expert

Job description

Job Description

As part of the drug product development, represent the GMP manufacturing of clinical supplies and provide expert support for all GMP aspects in the development projects and in external and internal GMP audits. Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines.
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Basic Major Activities
1.Actively participate in PHAD sub-teams, CS projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own discipline. Responsible for the independent planning and supervision of clinical supply in adherence with GMP requirements and project timelines. Delivery GMP compliant documentation and support worldwide registration processes. Execute process improvements, scale-up.
Drive process related trouble shooting / investigations. Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
2.Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). Lead product and process related investigations and deviations including complaints actions. Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures
3.Design, plan, perform, monitor and report assigned activities, e.g. provide front line support to manufacturing, working with the operator, focusing on manufacturing process and executing each batch safely, on time, in compliance with the batch instructions and quality requirements.
4.Ensure quality, quantity and timelines in all assigned projects, networks and/or plat-forms.
5.Support associates in specific projects and/or networks. Coach on target dates and priorities
6.Proactively contribute to budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects, networks and/or platforms.
7.Work according to appropriate SOP’s, GLP, GMP, QM, QD, HSE, ISEC and Novartis guidelines. Maintain processes at inspection readiness level and to provide the necessary support in any internal or external audit
8.Interpret results, evaluate data, draw relevant conclusions and write reports. Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product.
9.Support quality of clinical supply products through generation of documentation that provides clear evidence of compliance with Novartis QM, QD and global regulations.
10.Optimize scientific/technical related activities in assigned projects, networks and/or platforms. Create and implement optimized processes and procedures for activities within the own area of responsibilities. Support the execution of process validations, re-validations and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution. Review and assure that validation protocols and report are technically correct.. Ensure protocols are executed as intended.
11.Actively contribute to investigations with critical evaluations of events and actions to drive towards the continuous improvement of clinical supply operations
12.Interact/collaborate with other functions in Development to facilitate transfer of knowledge and deliverables with the production of clinical supplies.
13.Identify need and opportunity for outsourcing. Provide input to contracts and QA-agreements with 3rd parties and lead outsourced tasks/projects with 3rd parties as appropriate.
14.Support the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Support cultural evolution and change management.
15.Coach/lead team members: support objectives setting, performance evaluations and development planning discussions with team members where appropriate. Participate in recruiting process if applicable.
16.Monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, continuous improvement objectives to be achieved or corrective action to be taken.
17.Lead risk analyses and/or peer review and process challenge meetings.
18.Actively support TRD as a technical expert on audits and inspections.
19.Actively stay abreast and share with leaders industry trends or technology development that would benefit clinical supply operations.

Operational Development Specific Activities –
1.Plan and resource activities required for batch production.
2.Drive the plan and contribute to project batch production by proactively considering potential issues associated with equipment, instruments, and processes to allow resolution prior to initiation.
3.Create and implement efficient and robust procedures/processes for the manufacture of clinical products
4.Plan, create and execute appropriate change control management according to SOP and QM requirements
5.Coordinate with team members to ensure all activities required to support batch are successfully completed to maintain scheduled batch activities
6.Proactively provide ideas to enhance efficiency and/or effectiveness of operations.
7.Report and present own work at internal meetings
8.Demonstrate compliant GDP in all GMP records
9.Support all, and lead multiple, activities related to assigned projects

Key Performance Indicators (Indicate how performance for this job is measured)
1.Accountability for costs, quality, quantity, and timelines for all assigned tasks.
2.Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
3.Feedback from other team members/leaders.
4.Refer to annual individual and team objective setting.
5.Outcome of risk analyses, process challenge meetings, audits and inspections.
6.Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.

Posting Title

Manufacturing Expert

Desired profile

Minimum requirements

Education : Minimum: MS or equivalent

Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).

Languages: Good knowledge of English (oral and written). Desirable knowledge of site language.

Experience:
1.Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as principal scientist or equivalent.
2.Recognized expertise in a specific area.
3.Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs.
4.Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications.
5.Thorough understanding of development processes in a specific function.
6.Profound literature search skills.
7.Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
8.Proven leadership skills.
9.Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
10.Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.
11.May require up to 15% travel
Job Type

Full Time
Country

USA
Work Location

Fort Worth, TX
Functional Area

Technical Operations
Division

Global Drug Development
Business Unit

TECHNICAL R & D GDD
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.