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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