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Company Name : Applied Materials
Location : Mumbai, Maharashtra
Position : Technologist
Job Description : JOB RESPONSIBILITIES
Provide scientific and technical leadership in developing new pharmaceutical products. Perform literature search, pre-formulation investigations, formulation design, prototype formulation manufacturing in R&D environments, process scale-up and optimization at manufacturing facilities, manufacture of exhibit batch and clinical supplies and conducting stability studies.
Develop product development strategies. Identify and evaluate technology platforms. Makes recommendations and implements.
Identify and work with external partners such as CDMOs, CROs and Analytical Laboratories to develop dosage forms.
Perform all project related scientific/technical activities such as interpretation of regulations and patents, design of experiments, troubleshooting formulation and processing problems, evaluation of physical and analytical data, and careful documentation of all work. The above activities may be performed independently or under the guidance of management.
Prepare regulatory submission documents including the Product Development Report and other relevant sections of the CMC portion of the filing. Assist regulatory affairs in responding to FDA deficiencies.
Organize and manage the logistics of formulation development to ensure timely completion of all formulation development tasks.
Observe all safety and GMP guidances and adhere to internal SOPs.
Collaborate with multidisciplinary internal teams as well as external partners.
Regularly update the team and management on project activities and results through informal conversations and formal presentations.
Train and supervise junior scientists and technician when necessary.
QUALIFICATIONS
Masters or a Ph.D. degree in Pharmaceutical Sciences, Chemical Engineering or related field with relevant experience in pharmaceutical product development in pharmaceutical industry. MS – 3-5 years; Ph.D.- 2-3 years.
Experience and successful track record in development and regulatory submission of 505B2 products is a desirable. Experience with complex dosage forms including amorphous solid dispersions, long acting injectables is desirable. Experience in sterile dosage form development is a plus. Experience with QbD for product/process development is essential.
Knowledge of physicochemical and biopharmaceutical properties of pharmaceuticals is required.
The candidate must be self-motivated and be able to execute independently. Good problem solving and project management skills are critical for this position.
Must have excellent written, verbal communication and interpersonal skills.
Qualifications
Education:
Bachelor’s Degree
Skills
Certifications:
Languages:
Years of Experience:
4 – 7 Years
Work Experience:
Additional Information
Travel:
Yes, 10% of the Time
Relocation Eligible:
Yes
Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law.
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