Officer

Purpose

Responsible for the development of new products and optimization of existing formulas; product lines including Oral dosage forms like Solutions, Suspensions, Tablets & Capsules for regulated markets like US, Europe and ROW. Perform duties in accordance with Rubicon policies and procedures.

Position / Job Title

Officer

Department

Formulation Development

Reporting To

Sr. Manager

Location

Thane

Years Of Experience

2+ years

Dosage Form

Solid Orals / Liquid Orals

Job Responsibilities / Deliverables

To understand project scope, define the activities and timelines and to ensure periodic monitoring and timely completion of the same.

To read and understand all the literature references such as strategy document, relevant patents, FOI, EPAR, DMF, Google references etc.

To plan and ensure execution of day-to-day laboratory experiments in timely manner.

To identify the resource requirement for the projects such as materials, manpower, machine change parts as well as to assimilate all the literature information collected by project teams and ensure appropriate usage throughout development.

To analyze the data, draw conclusions & plan further experiments in the form of appropriate design of experiments based on Qbd principles after consultation with superiors.

To effectively monitor/execute & document lab scale stability/scale up/optimization and pilot BE batches.

Timely complete the Lab experiment notebooks as well as preparation and review of technology transfer documents

To strictly ensure complete adherence to GMP & systems during day-to-day laboratory activities.

To coordinate the logistics related to materials, man power and machines.

Check stability protocols, monitor stability studies and evaluate/interpret the results to advance further for product development activity accordingly.

To generate and review the relevant documents such as MFC, BMR, PDR, etc. within the specified time as per the standard format.

To prepare new departmental SOPs, manuals and guidelines documents as on when required as well as to renew existing SOPs, manuals and guidelines documents.

To monitor IQ, OQ and PQ activities of new machines and to ensure proper functioning & maintenance of all equipment & instruments including necessary.

To ensure proper storage & destruction of raw materials & finished goods and to maintain up to date RLD samples inventory.

Qualifications & Pre-Requisites

Minimum Master's Degree in Pharmaceutical sciences educational background with 2+ years relevant experience.

Candidate should have hands on/practical experience on development, technology transfer and ANDA submissions for Oral dosage forms like Solutions, Suspensions, Tablets & Capsules for regulated markets like US, Europe and ROW. Experience on pellets would be considered as additional advantage.

Broad knowledge base of pharmaceutical sciences and processing in the Pharma industry.

Strong understanding of the product development process from concept ideation to launch.

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.