Job Description
Purpose
Senior Manager Formulation Development leads pharmaceutical product development from concept to technology transfer, ensuring timely execution using QbD and DoE principles. The role involves project planning, cross-functional coordination, resource management, GMP compliance, documentation oversight, scale-up activities, client communication, and team leadership to ensure successful and compliant product development.
Position / Job Title
Senior Manager
Department
Formulation Development
Reporting To
Sr. General Manager
Location
Thane
Years Of Experience
15 + years
Dosage Form
Solid & Liquid Oral, Pellets, MUPS
Job Responsibilities / Deliverables
To understand the project scope, define the activities and timelines and to ensure periodic monitoring and timely completion of the same.
To monitor the execution of the strategies as approved in the strategy document in the form of appropriate design of experiments and based on Qbd principles.
To identify the resource requirement for the projects such as materials, man-power, machine change parts.
To assimilate all the literature information collected by project teams and ensure appropriate usage throughout development.
To periodically review the progress of the project with the team for experimental planning & execution of laboratory experiments.
To effectively plan & coordinate execution of scale up/ optimization and pilot BE batches.
To ensure adherence to GMP & systems during day-to-day laboratory activities.
To coordinate and execute technology transfer/scale up activities with the team and proposed site.
To review and finalize the relevant documents such as MFC, BMR, STP, PDR, CPS, IDR etc. within the specified time.
To periodically review the laboratory notebooks & to ensure compliance.
To prepare/review minutes of the meetings/telecons & monthly status reports.
To liaison with the clients for sharing the progress of the project, seeking concurrences for the future course of action wherever required and keeping them updated.
To liaison with other departments such as Stores, QA, RA, BD, IP, CTS site etc.
To coordinate project meetings & ensure clear and transparent communication amongst all the team members.
To ensure proper functioning & maintenance of all equipments & instruments including necessary calibrations.
To ensure proper training of the subordinates, technicians and house-keeping personnel on various equipment, instruments, and systems in the department.
To ensure proper storage & destruction of raw materials & finished goods.
To participate in the departmental Audits and ensure compliance to the recommendations.
To read and update oneself/ team with the latest developments w.r.t. technology, conceptual thinking, presentation, and communication skills.
To monitor IQ, OQ and PQ activities of new machines.
To identify and coordinate with HR for departmental manpower requirement.
Qualifications & Pre-Requisites
Master in pharmacy/Ph.D (Pharmaceutics)
Must-Have Skills: Formulation development experience of Solid, Liquid Oral and Pellets project experience.
Additional Notes
Role is expected to work in extended hours/any of the shift based on the requirement.
Expected to visit manufacturing sites, whenever required.
