Hybrid Formulation Researcher II (Ambernath, India, 421506) na Teva Pharmaceutical Industries
Teva Pharmaceutical Industries · Ambernath, Índia · Hybrid
- Senior
- Escritório em Ambernath
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
- Bench scientist with good analytical acumen in the area of formulation research and development, process development, Regulatory and Intellectual property for global markets.
- Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE.
- Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scaleup principles.
- Ability to comprehend facts and data from literature reviewed and present the information effectively for decision making.
- Understand IP scenario and work on various design around strategies, search prior art, and experimentaly establish the proof of concept.
- Help identify the challenges assocaited, bottle necks in development and suggest mitigation 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).
- Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues.
- Priortize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization.
- Align day to day activities in line with established milestones, execution of batches at global TGO operation site.
- Clear comminications with internal stakeholders, for identfying challenges/risk areas which would hamper the timely delivery of products.
- Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives.
- Assist the domain leader in business process evalaution and identifying improvement areas.
- Demonstrate personal accountability and effective work habits, viz. working productively & act responsibly, and learn from mistakes.
How you’ll spend your day
- Work on bench with the formulation development teams for the timely achievement of key milestones.
- Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE.
- Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data
- To conduct literature review, prior art experiment design of the product identified for development.
- Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering.
- Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic formphase transformation studies, selection of excipients and process as per strategy.
- Conducting and performing the development trial at bench level, problem identification & resolution.
- Review and interpretation of analytical data for further action plan.
- Responsible for execution of Pilot BE batches and interpretation of bio results.
- Responsible for execution of scale-up and exhibit batches at different 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).
- Establish the stability data for development batches in collaboration with the analytical team.
- Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report.
- Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product.
- Compilation and preparation of pharmaceutical development report with respect to current QbD format.
- Responsible for preparation of Product Developmental Report (PDR) for filling.
- Handling of deviations, change control and OOS related to Exhibit batches.
- Preparation, updation of SOPs.
- Maintaining of batch, calibration and other necessary records.
- Subjecting required batches to stability studies.
- Successful demonstration of proof of concept and ensure prospective documentation in line with QbD paradigm.
- Discuss and deliberate needful measures for timely execution of batches and ensure regulatory filing, approval and launch of generic drug products.
Your experience and qualifications
- Ph.D. in Pharmaceutical Sciences with 3 Yrs +/ M.Pharm in Pharmaceutical Sciences with 6 to 10 years from reputed universities
- Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada.
Skills and specific knowledge required
Technical skills
- Formulation Development of Solid Oral Dosage forms, exposure from development and submision to regulatory agencies.
- SME within team and Provides solutions to moderate problems within team.
- Frequent use of scientific theories and principles.
- Good learning acumen
- Basic level understanding on recent ICH, regulatory guidelines, IP requirements; understanding of Bioequivalence, GMP, Quality and SOP compliance, GLP etc.
People Skills
- Must be Confident, able to work in the team and a good team player
- Stable and calm, Supports functional colleagues
- Shows respect, listens effectively, show caring
- Strong technical communication skills, has the ability to take comprehend facts and data to help the decision making.
- Shows respect, listens effectively, show caring & be compliant with the core values of TEVA
- Demonstrates timeliness
Inter personal Skills
- Collaborates with team within functionional area and cross functional teams.
- Strong technical communication applied applied locally and contributor to local and/or global project teams.
- Delivers technical presentations & Recommends project strategy
- Ability to work with very little supervision, Train and supervise junior staff
- Ability to work independtly on individual products.
- Mentors functional colleagues.
- Manages internal and external partners.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
