Manager, Formulation Development (Injectable)

Par Pharmaceuticals

Par Pharmaceuticals

Posted on Thursday, July 11, 2024

Job Description Summary

The Manager, Formulation Development is deft in development of formulation, 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 trails, scale, and documentation for both generic as well as branded products.

Job Description

Formulation development manager shall be responsible for-

  • Formulation development activities assigned related to NDA/ANDA by HOD/Manager/Designee Formulation development activities assigned related to NDA/ANDA by HOD/Manager/Designee
  • To carry out the literature search on APIs, reviewing DMF, patents, excipients database, technologies for the development of formulation. SBOA review Innovator Product Characterization & planning formulation strategies along with assessment of QTPP & CQA
  • To coordinate with cross functional teams (ARD, RA, DQA, Compliance, PM, Plant TT, SCM etc.) for the timely completion of assigned activities.
  • Development of stable prototype formulations & technology transfer of generic as well as Branded Project assigned. To provide support to preclinical/clinical team wrt stable formulation/placebo batch fabrication, studies like F/T, reconstitution stability, hold time, syringe functionality tests, etc. required prior to animal/clinical studies.
  • To perform the formulation technology transfer from PD lab to respective manufacturing unit/ pilot plant with required documentation e.g. PDR.

Education & Experience:

  • M. Pharma with min 11 years experience in complex injectables.

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.