Job Description Summary
The Formulation Development Deputy Manager is deft in development of formulation (Complex Injectables, Branded products-NDA & BLA), scale up and demonstration of scientific capability and accessibility to current portfolio and pipeline products. The incumbent will also be jointly responsible for achieving targeted formulation development by providing necessary scientific support to team members. This role is responsible for literature search, formulation development trials, Tech transfer & scale-up, and documentation.
Job Description
- To perform Formulation development assigned by HOD/Manager/Designee.
- To carry out the Literature search on APIs, Reviewing DMF, patents, excipients, technologies for the development of formulation. SBOA review Innovator Product Characterization & planning formulation strategies along with assessment of QTPP & CQA.
- To Plan and execute the predevelopment/ pre-formulation study. Development lab trials and stability batches and optimization of formula & manufacturing process, performing the QbD /DoE based trials.
- To prepare documents related to product development and scale up documents, drafting tentative specification for API, RM and finished product based on scientific rationale.
- To compile and interpretation of product development results, drawing conclusions. To compile the product development strategy along with HOD/ Manager/ designee. To work out a project plan specifying timelines and target completion dates.
- To coordinate with cross functional teams for the timely completion of assigned activities.
- To support the formulation technology transfer from PD lab to respective manufacturing unit/ pilot plant with required documentation.
- To assist Regulatory Department in Post development activity by preparing appropriate response to queries from regulatory bodies.
Qualification & Experience
M. Pharm/PhD in Pharmaceutics with 7-9 years of Complex Injectable formulation development experience.
Commitment To Diversity, Equity, And Inclusion
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
