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Are you looking for Chemical Engineering Jobs in the biopharmaceutical industry with a leading innovation-driven organization? Explore exciting Syngene Careers with this Lead Formulation Development opportunity in Bangalore. If you have expertise in sterile injectable formulations and biologics development, this could be the perfect next step in your professional journey with Syngene Jobs.
About Syngene
Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.
JOB DESCRIPTION
- Job Title: Lead Formulation Development
- Job Location: Bangalore
- Department: Biopharmaceutical Development
Core Purpose of the Role:
- Develop and optimize sterile injectable formulations for biologics, including liquid and lyophilized dosage forms.
- Design and execute pre-formulation studies, excipient compatibility assessments, forced degradation, and stability studies.
- Drive early and late-stage formulation development and support transition from preclinical to clinical and commercial.
- Collaborate with clinical operations to design and execute in-use compatibility studies.
- Design and execute formulation characterization studies.
- Execute technology transfer to pilot-scale, clinical, and commercial manufacturing sites.
- Collaborate with CMC, process development, and manufacturing teams to develop commercial formulations.
- Prepare and review regulatory documents (IND, BLA, IMPD, etc) to support clinical and commercial filings.
- Ensure compliance with cGMP, ICH, FDA, and EMEA guidelines for formulation and process development.
- Work closely with analytical development, quality assurance, and regulatory teams to ensure successful formulation development.
- Mentor and provide scientific/technical guidance to junior scientists and external partners.
Role Accountabilities:
The ideal candidate should have experience in the biopharmaceutical industry, with expertise in early- and late-stage formulation development, process characterization, scale-up, and technology transfer. This role will focus on designing robust drug product formulations, scaling up manufacturing processes, executing process validation lots and authoring regulatory submissions. He/she will work in close collaboration with the Head of Biologics Development to drive the project milestones.
Leadership Capabilities:
- Innovation & Problem-Solving – Lead formulation design and troubleshoot challenges.
- Operational Excellence – Deliver projects on time, within cost, and with quality.
- Stakeholder Management – Coordinate with leadership, partners, and regulators.
Experience: We are seeking an experienced Drug Product Formulation to lead formulation development for sterile injectable products, including liquid and lyophilized formulations. The ideal candidate should have experience in the biopharmaceutical industry, with expertise in early- and late-stage formulation development, process characterization, scale-up, and technology transfer. This role will focus on designing robust drug product formulations, scaling up manufacturing processes, executing process validation lots, and authoring regulatory submissions. He/she will work in close collaboration with the Head of Biologics Development to drive the project milestones.
Skills and Capabilities:
Drug Product Formulation lead formulation development for sterile injectable products, including liquid and lyophilized formulations.
Education:
PhD or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
