Teva Associate Director Site Engagement 

United States, Pennsylvania, East Bradford Township 

765008696

• 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.

• 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.

• 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.

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.