About the role
Title
Global EM Pharma Technology Associate India
Working Hours / Shift
General
Location
Mumbai
Contract Duration
1 Year
Key Words/objective of the role
- Pharma background
- Project Management skill
- Process Validation
- Knowledge in Good Manufacturing Practice (GMP)
- Open to travel
Day to day responsibilities
Mentioned in JD
Work Experience / Background
5+ Years
Education / Qualifications required
Mentioned in JD
Key Accountabilities
Provide technical support of commercial Pharma and Biotech drug product, as well as Pharma drug substance
manufacturing operations performed for partially outsourced products. This position is responsible for providing
pharmaceutical technical knowledge for all aspects of continuous improvements, support technology transfer, and take
over after transfer, process scale-up, monitoring (incl. CPV/OPV Annex 15 GMP requirements), troubleshooting and Life
Cycle Management (when required).
The Site Pharm Tech function that has been assigned to cover the technology expertise for a product or product category
has responsibility for providing technical support of commercial drug substance, drug product and finished product
manufacturing operations performed partially at third party manufacturers.
The position requires cross-functional collaboration with external contractors and internal partners including
Manufacturing, Quality, Regulatory, Process Development and Engineering and to provide technical consultancy in
support of product manufacturing and New Product Introduction.
· Primary site contact for technical topics towards the CMO
· Leading technology transfer activities in the region for local products upon assignment.
· To provide technical product and pharmaceutical expertise within the multi-disciplinary teams (e.g. CMC,
GPST, VPT) to define optimal activity plans, by challenging team's requests and defining the priorities
· Technical support activities/projects for manufacture of late-stage products at third party manufacturing
facilities.
· Support role out of global projects from CMC roadmaps to the relevant CMOs
· Identify technical risks / gaps in process robustness and propose technical solutions
· Accountable for the accumulated know how and experience related to assigned molecule/product and its
manufacturing process
· Provide significant technical depth to support troubleshooting efforts and provide support to high-level
deviation investigations in conjunction with third party contractors and internal partners (Process
Development, Manufacturing, and Quality).
· Propose checkpoints for the molecule/product related GHO activities to the stakeholders
· Collaborate with Quality, GPM Technical Operations, VPT and Regulatory to optimize Product flow and Life
Cycle Management.
Strategic Impact
· The current expansion of CMOs is taking their significant share of total Client Pharma production, making
CMOs a large, strategic part of the Client Healthcare Operations, and the external supply network and an
integral part of the approved agile supply strategy- the job holder is responsible for ensuring that the
Technology related knowledge applicable to the products manufactured partially externally is established and
increased internally in his/her function and providing science in order to secure quality and supply at attractive
conditions. Support identification of cooperation partners / CMO selection / Due diligence (if/as driven by
technology/technical aspects)
· Be the technical counterpart of PO (procurement) for review and approval of technical work-scopes and
investments at the CMOs.
Cooperation
Internally Externally
§ Procurement, for investment programs and work
scope
§ SNO- locally, regionally and globally, for product
supply related technical topics
§ Local QA/ESQ- to ensure that production at
CMOs is compliant with all Client requirements.
§ EM internal (VPLs)
§ Controlling, Pricing and compliance
§ Manufacturing sites & Affiliates
§ Engineering
§ GEM-PT team for best practice sharing and
exchange of knowledge
§ Liaise with GPM MST, GBM MSAT or GCD CMC
functions for knowledge sharing
§ External Suppliers / CMOs