Manager/Sr. Manager/AVP, R&D (Injectable Formulation)

Job Description

Title: Manager/Sr. Manager/AVP, R&D (Injectable Formulation)

Company Name: SQUARE Pharmaceuticals PLC.

Vacancy: 1

Location: Dhaka, Gazipur

Experience:
∎ 10 to 12 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies

Published: 3 Apr 2024

Education:
∎ M. Pharm including PhD(Pharmacy) having 10 to 12 years of experience
∎ M. Pharm including PhD(Pharmacy) having 10 to 12 years of experience

Requirements:

Responsibilities & Context:
∎ Provide guidance and scientific leadership to the team for development of complex Injectable formulation PFS, lyophilized injection, ophthalmic products, RTU injection & liquid injections etc. as per requirement of US, Europe, RoW, Domestic Markets.
∎ Assess the patents proposal of development strategy of non-infringing formulations including Para IV,505b2 filing.
∎ Conduct various studies, including delamination extractable & leachable study, filter compatibility, tubing compatibility, gas compatibility, selection of container and closure, freeze thaw studies etc.
∎ Ensure successful technology transfer of formulation and process from R&D to manufacturing site and handle troubleshooting of existing products related to product development and process development
∎ Support to regulatory teams for preparation of regulatory documents like QbD-based product development report, 3.2.P.2, packaging development report, QbR-QOS, etc.
∎ Ensure compliance of GDP/GLP, Safety, Health and Environment Policy of Organization
∎ SQUARE Pharmaceuticals PLC., the flagship company of SQUARE Group and certified by major international pharmaceutical regulatory authorities, is holding the 1st position in the pharmaceutical industry among all national and multinational companies of Bangladesh since 1985. SQUARE Pharmaceuticals PLC. has become a global player starting its operation in Kenya. Right now we are looking for smart, energetic and result oriented team members, who will share with us our pride and support our continuous growth.
∎ Major Duties and responsibilities:
∎ Provide guidance and scientific leadership to the team for development of complex Injectable formulation PFS, lyophilized injection, ophthalmic products, RTU injection & liquid injections etc. as per requirement of US, Europe, RoW, Domestic Markets.
∎ Assess the patents proposal of development strategy of non-infringing formulations including Para IV,505b2 filing.
∎ Conduct various studies, including delamination extractable & leachable study, filter compatibility, tubing compatibility, gas compatibility, selection of container and closure, freeze thaw studies etc.
∎ Ensure successful technology transfer of formulation and process from R&D to manufacturing site and handle troubleshooting of existing products related to product development and process development
∎ Support to regulatory teams for preparation of regulatory documents like QbD-based product development report, 3.2.P.2, packaging development report, QbR-QOS, etc.
∎ Ensure compliance of GDP/GLP, Safety, Health and Environment Policy of Organization

Skills & Expertise:

Compensation & Other Benefits:
∎ Competitive package will be offered
∎ Competitive package will be offered

Employment Status: Contractual

Job Location: Dhaka, Gazipur

Read Before Apply:

For Apply and job details: http://career.squarepharma.com.bd/?src=dtlsjob&jid=622

Only short-listed candidates will be called for further selection process. Hard copy of CV will not be entertained.

SQUARE NEVER ASKS FOR MONEY FROM ANY CANDIDATE AT ANY PHASE OF RECRUITMENT

SQUARE STRONGLY DISCOURAGES SMOKERS TO APPLY.