Opening For Research Scientist-
Analytical / Formulation Development
1) Research Scientist – Formulation Development
Functional
Area: Formulation Development
Education:
M.Pharm – Pharmaceutics/Pharmaceuticals Technology
Experience:
5 to 10 Years
Location:
Indore
Technical Competencies:
1)
Candidate with minimum 5 years of experience in the area of development of
complex injectable formulations (Generic & 505 (b) (2)) for North America,
EU and other regulated markets.
2) The
candidate should have experience of working on sterile dosage forms, preferably
on in-situ depot formulations, injectable suspensions, nanoparticles and
lyophilized products, etc.
3)
Knowledge of different medical devices like pens, PFS and auto injector is
desirable.
Job
Responsibilities:
1)
Responsible for generic and NDA formulation development of sterile dosage forms
for regulated and non – regulated markets.
2)
Conduct Literature search, patent evaluation and preparation of literature
report.
3)
Preparation and/or review of documents such as formulation development approach
paper, stability protocol and report, drug – excipient study protocol and
report, bill of material, master formula card, batch manufacturing record,
product development report, SOP, format, CoA, etc.
4)
Pre-Formulation studies including API and innovator product characterization
etc.
5)
Manufacturing of lab scale batches and evaluation of in-process, finished
products and stability samples.
6)
Execution of technology transfer and monitoring of scale-up, pilot,
trail/engineering, exhibit/registration batches and validation activities at
plant.
7) Must
have knowledge and expertise in aseptic area and handling of
machinery/equipments related to sterile dosage forms.
8)
Issuance, Maintenance, Writing, Review of raw data, Completeness checks and
archival of laboratory notebook.
9)
Review and/or approve documents and provide technical support to production
team during technology transfer and/or validation whenever applicable.
10)
Routine calibration and qualification of laboratory instruments and equipments.
11)
Support GDP, GLP, Internal and External audit and compliance related activities
within department to be in-line with QMS and USFDA requirement.
12)
Follow strict adherence to Good Documentation Practices and Good Laboratory
Practices.
13)
Candidates with hands-on experience in QbD and DoE preferred.
14) Must
have good communication, writing and inter-personal skills.
15)
Effective Planning, Quality execution and organization of work is a must.
16) Any
other duties as per organizational requirements.
2) Research Scientist – Analytical Development
Functional
Area: Analytical Development
Education:
M.Pharm & M.Sc
Experience:
5 to 10 years relevant experience
Technical Competencies
1)
Candidate with minimum 5 years of experience in the area of complex injectable
formulations (Generic & 505(b) (2)) for North America, EU and other
regulated markets.
2) The
Candidates should have experience of working on sterile dosage forms,
preferably on in-situ depot formulations, injectable suspension, nanoparticles
and lyophilized products etc.
3)
Knowledge/experience on different dissolution techniques, reverse engineering
for Q1/Q2/Q3 and sameness study is desirable.
Job Responsibilities:
1)
Independent handling of assigned projects of sterile dosage forms for regulated
and non –regulated market.
2) Close
monitoring and review of analytical raw data generated for developmental, routine,
stability analysis of lab scale batches, method validation and verification
activities.
3)
Technical evaluation of assigned projects including all kinds of development
and validation activities as per project requirements, trouble shooting and
helping team for timely execution of project as per committed target completion
date.
4)
Preparation and/or review of documents such as development approach paper,
method development report, product specification and test procedures, method
validation protocols and reports, SOP, formats, CoA preparation etc.
5)
Review and/or approve Formulation Development documents including stability
protocols, compatibility study protocols, QTPP and other as per project
requirements.
6)
Review and/or approve documents and provide technical support tQC team during
method transfer and/or validation whenever applicable.
7)
Execute installation and qualification procedures for instruments and equipment
and monitor calibration of all instruments and equipment as required.
8)
Co-ordination with service engineers for instrument and equipment maintenance
and trouble shooting.
9)
Monitor audit trail of HPLC and other instrument software with periodic review
of soft data and keep control on all required parameters.
10)
Close interaction with Formulation Development department for Project
management, technical discussion and work management of assigned projects.
11)
Monitor and support GDP, GLP, Internal and External audit and compliance
related activities within department to be in-line with QMS and USFDA
requirement.
12)
Impart Project specific and/or other related training to department and within
team as necessary.
13)
Assess outside CRO for any analysis and monitor project related activities.
14) Must
have strong communication, technical writing and presentation skills.
15)
Effective Planning, Quality execution and organization of work is a must.
16)
Prior exposure to audits like USFDA, EU, TGA preferred.
17) Any
Other duties as per organizational requirements.
Interested
candidates please share your cv on hrd.sez@symbiotec.in or
can contact on 07292-667-605
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