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Post : Manager - MPD Process - AMA PHC

Job Description
This is a B1 position for Material Process Delivery (MPD) Base Business (BB) department for Asia Middle East Africa (AMA) region.
The candidate will be responsible for various technical skills of pharmaceutical product development & technology transfers, from formulation development to the scale up & process validation at various manufacturing sites across India and to extend support for similar activities carried out across AMA region.
A sound knowledge of technical documentation is required in the role to be prepared pre & post Technology Transfer in line with ICH, WHO guidelines along with experience in dossier writing for quality module in CTD format.
The role includes tech transfer of new/existing products to contract manufacturing (CM) locations and support to multi-function teams (ESS, Production, QA, Procurement) during manufacturing of 1st three validation batches.
The role requires co-ordination with MPD- Process team members while performing stability study demonstration of the batches incubated at various conditions in line with ICH/WHO stability guidelines.
During technology transfers, travel across CM sites in India will be required.

Key Responsibilities :
• Coordination with MPD (process & ADL) and various cross functional departments (QA, Purchases, ESS Operations) to support in Technology Transfer (TT) of products at existing & new contract manufacturing locations.
• To review & approve various tech. documents like TTP/MFR/HTS/TTR prior & post TT and dossiers of prospective C&G products to be outsourced.
• To participate in periodic meetings with multi-functional teams and opine on technical matters (Ex: New RM supplier qualification), update MPD projects’ progress, and work on regional MPD Processes.
• To maintain equipment in PPI Lab, Goa (Calibration and preventive maintenance) and to liaison daily with PPI Lab Goa on progress of tasks.
• To take ownership of document management software (VEEVA) for change control, deviation & CAPA systems including create/review/approve technical standards for RM, Intermediate and FG and departmental SOPs.
• To carry out stability study - Initiation & maintenance of data of following products of
a) New Site Transferred products commercial PV batches,
b) AVD/ BCP – In scope products commercial PV batches/Small scale batches

Candidate Profile
• M. Pharm Pharmaceutics /Ph. D. in pharmaceutical science from Reputed colleges. + MBA would be treated as an add-on qualification.
• 11-15 years’ experience in Pharma consumer product's R&D + Technology Transfer function with skill sets mentioned above of pharma dosage forms viz Tablets, capsules (SG,HG), liquid Oral, Nasal, Liquid Orals, SVPs
• Should have excellent communication, interpersonal skills, power point presentation skills, both oral and written English.
• Should be agile, shall have good managerial skills, shall be a team leader and should have problem solving ability.
• Should be with positive attitude, result oriented, competent and a good team-player with a customer focus mindset
• Should have good digital/soft skills to work in the digitized space required for Technical documents generation.
• Should have Good Project Management, Planning & Organizing skills
• Should have knowledge of various ICH guidelines on stability, process validation and quality & risk Management, Pharmacopoeia like IP/BP/USP,EP etc.

Additional Information
Experience : 11-15 years
Qualification : M.Pharm Pharmaceutics / Ph.D
Location : Mumbai
Industry Type : Pharma
Job Number : R000068236
End Date : 10th March, 2023