Manager Formulation, Process Development

Shantha Biologics Pvt. Ltd.; Hyderabad; Sur place; INR 4 000 000 - 7 000 000; Plein temps

Résumé du poste

Shantha Biologics Private Limited in Hyderabad seeks a seasoned Formulation Development professional to lead vaccine formulation efforts. The role involves designing formulations for pediatric and adult vaccines, planning experiments, and ensuring cGMP compliance during development and technology transfer.

The candidate will mentor junior scientists, guide process development, and contribute to continuous improvement initiatives to enhance product quality and robustness.

Qualifications

• M.Pharm/B.Pharm/M.Sc in Life Sciences with relevant industry experience; PhD is an added advantage.
• 10–15 years of experience in formulation development, preferably vaccines or biologics.
• Experience with cGMP and regulatory considerations for technology transfer.

Responsabilités

• Design and optimize vaccine formulations (antigen, adjuvant, stabilizers, buffers).
• Plan, execute, and review lab experiments and development studies.
• Ensure adherence to cGMP during formulation development and tech transfer.
• Provide training and mentoring to junior scientists and staff.
• Contribute to investigations, risk assessments, and continuous improvement.

Connaissances

Vaccine Formulation

cGMP Compliance

Mentoring

Literature Search

Formation

M.Pharm / B.Pharm / M.Sc Life Sciences

PhD in related field (advantage)

Outils

Laboratory Techniques

Process Development

Description du poste

Roles & Responsibilities (with key Expertise)

• Expertise in formulation development activities for pediatric and adult combination vaccines (pentavalent, hexavalent, heptavalent and other antigen combinations).
• Design and optimize vaccine formulations (antigen, adjuvant, stabilizers, buffers) to ensure safety, efficacy, and stability.
• Expertise in formulation development of bacterial, viral and conjugate vaccines, including multivalent and adjuvanted formulations
• Plan, execute, and review laboratory experiments and developmental studies related to formulation and process parameters.
• Ensure adherence to cGMP and other applicable regulatory guidelines during formulation development and technology transfer.
• Provide technical guidance, training, and mentoring to junior scientists and formulation staff within the R&D department.
• Participate in investigations, risk assessments, and continuous improvement initiatives to enhance product quality and process robustness.
• Proficient in systematic online literature search and patent database searching using advanced search strategies to support process development activities.

Work Location

Qualifications & Experience

• M.Pharm/ B.Pharm / M.Sc. Biotechnology / Microbiology / Biochemistry / Life Sciences with relevant industry experience may be considered OR Ph.D. in Pharmaceutical Sciences, Biotechnology, Immunology, Microbiology, or related discipline will be an added advantage.

Experience

10–15 years of experience in formulation development, preferably in vaccines or biologics.