Job Description

Vacancy for Formulation Researcher at Teva 2023.

Organization	Teva
Post Name	Formulation Researcher II- Topical Formulations
Job Location	Ambernath
Official Website	https://www.tevapharm.com/

Job Title/Position:

Formulation Researcher II- Topical Formulations

Job Overview:

Job vacancy for Pharmacy

Job Location:

Ambernath, India

What are the Key Responsibilities?

Bench level scientist with good scientific accumen of Complex Topical Dosage Forms (Cream, Ointment, Gel, Lotions, solutions but not limited to) development, process development, Regulatory and Intellectual property for global markets.
Planning and conducting of experimentation in line with QbD paradigm, using OFATs/DOE
Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scale up principles.
Ability to articulate facts and data from literature reviewed and present the information effectively for decision making.
Understand IP scenario and able to make different strategies, search prior art, and experimentally establish the proof of concept.
Should have experience of end-to-end QBD based product development and consideration of scale up factors pertaining to Topical Formulations
Must be familiar with De-formulation/Reverse engineering for topical formulations with respect to Q1/Q2 establishment.
Working experience of physicochemical properties (Q3) of Topical formulation, Topical formulation characterization techniques, Crystallography/Crystal habit, Rheological similarity establishment methodologies
Able to extend support to group lead/senior for query response with respect to Topical formulations from different regulatory body.
Hands on experience of product transfer from bench scale to Shop floor accompanying with different scale up factors for product transfer in accordance with Topicals.
Ability to work in a team with risk anticipation and suggest mitigation plan/ proposals during development at various stages.
Co-ordinate with CFTs viz. MS&T, QA, QC and production at different geographies for technology transfer and timely execution of submission batch(es).
Prioritize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization.
Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues.
Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives.
Assist the domain leader in business process evaluation and identifying improvement areas.
Work on bench with the formulation development teams for the timely achievement of key milestones
Planning of experimentation in line with QbD paradigm, using OFATs and DOE
Preparing technical presentations during Products development at various stages as per requirements and discuss/interpret the data.
To conduct literature, patent review and executions of lab trials as per proposed plan
Conduct and interpret data from Preformulation studies viz. Compatibility studies, Solid state characterization study, API Solubility studies, polymorphic form phase transformation studies, selection of excipients grades and process as per strategy
Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering.
Review and interpretation of analytical data for further experimentation planning
Responsible for execution of Pilot BE batches and interpretation of bio results
Along with suitable work functions interpret data of In-Vitro Release Test (IVRT) bioequivalence study and In-vitro Permeation Test (IVPT) bioequivalence study.
Responsible for execution of scale-up and exhibit batches at identified manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results.
Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE)
Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report etc.
Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MS&T, DQA and clinical for smooth development of product
Conduct formulation, process optimization trials for preparation of product development report as per regulatory requirement
Handling of deviations, change control and OOS related to Exhibit batches.
Preparation, updation and upkeep of departmental SOPs
Maintaining of batch, calibration and other necessary records
Discuss and deliberate needful measures for timely execution of batches and ensure regulatory filing, approval and launch of generic drug products

What are the Educational Qualification(s) for Formulation Researcher II?

Ph.D. in Pharmaceutical Sciences with 3 Yrs. +/ M.Pharm in Pharmaceutical Sciences with 6yrs+ from reputed universities.

What is the Experience Required for this Job?

Experience in working in a high-performance team in known generic space/ organizations with known generic footprint in regulated markets. Viz. US/EU/Canada.
3+ Yrs

What are the Preferred Skills required for this Job/Position?

Formulation Development of diverse Topical Dosage forms, exposure end-to-end development and submission to regulatory agencies
Trouble shooting acumen for various formulation and process related problems.
Full understanding of scientific theories and principles pertaining to Topical Product Development
Good learning acumen in ANDA submission, deficiency addressal and Post submission Validation at TGO
Emerging level understanding on recent regulatory guidelines, IP requirements; understanding of Bioequivalence, GMP, Quality and SOP compliance, GLP etc.
Must be Confident, able to lead the team, Self-initiator and a good team player.
Stable and calm, supports functional colleagues Influences cross functionally.
Should have good communication skills , has the ability to comprehend facts and data to help the decision making
Positive mindset with aspiration approach
Identify and help mitigate conflict.
Shows respect, listens effectively, show caring & be compliant with the core values of TEVA.
Demonstrates timeliness.
Collaborates with intra and inter team within functional area.
Good in technical communication applied at function and known Key technical contributor to local project teams.
Ability to work with very little supervision, Train and supervise junior staff.
Ability to work independently on assigned projects.
Mentors and coaches’ functional colleagues
Able to Manages internal and external partners.

Related:

Detailed notice

https://careers.teva/job/Ambernath-Formulation-Researcher-II-Indi-421506/1083414900/

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