Research Scientist - Formulation Development

Unichem Laboratories; North Goa; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Unichem Laboratories is seeking a seasoned formulation development professional in India to lead process development and support regulatory submissions for US/EU markets. You will drive QbD/DOE projects, oversee tech transfers, and guide scale-up activities across tablet and capsule dosage forms.

Strong presentation and communication skills are essential, along with hands-on equipment experience and a proactive, self-driven mindset.

Qualifications

• Must have experience of formulation development in reputed pharma organizations.
• Must have exposure to tablets, capsules, pellets dosage forms for regulatory markets (US/EU).
• Thorough knowledge on exhibit and validation philosophy and should have scientific evaluation methodology.
• Process development skills and handling of equipment's ensuring safety principles.
• Hands on experience on equipment's and planning of exhibit batches.
• Strong technical presentations skills.
• Good Communication and problem solving skills.
• Should be assertive, proactive and self-driven.
• Sound knowledge on quality management systems.

Responsibilities

• Participate in development phase to understand the process / technology.
• Ensure process optimization and finalization of critical process parameters with QbD / DOE concept.
• Provide technical inputs for preparation of batch manufacturing documents (BMR/Protocol/Sampling plan).
• Prepare scale up report and provide relevant recommendation if any.
• Review process qualification report and provide relevant recommendation if any.
• Perform gap analysis (technical) and provide technical support for site transfers/new launch products.
• Technical support for process improvement projects and trouble shooting.
• Handle OOS/OOT/Deviation during execution /new launch products.
• Impart training on new products through tech transfer presentations to cross functional departments.
• Identify and support the introduction of new technologies and equipment (e.g. manufacturing equipment)

Skills

Formulation development

Dosage forms (tablet/capsule)

Regulatory exposure (US/EU)

Process development

Tech transfer presentations

Job description

RESPONSIBILITIES

• Participate in development phase to understand the process / technology.
• Ensure process optimization and finalization of critical process parameters with QbD / DOE concept.
• Provide technical inputs for preparation of batch manufacturing documents (BMR/Protocol/Sampling plan).
• Prepare scale up report and provide relevant recommendation if any.
• Review process qualification report and provide relevant recommendation if any.
• Perform gap analysis (technical) and provide technical support for site transfers/new launch products.
• Technical support for process improvement projects and trouble shooting.
• Handle OOS/OOT/Deviation during execution /new launch products.
• Impart training on new products through tech transfer presentations to cross functional departments.
• Identify and support the introduction of new technologies and equipment (e.g. manufacturing equipment)

DESIRED SKILLS

• Must have experience of formulation development in reputed pharma organizations.
• Must have exposure to tablets, capsules, pellets dosage forms for regulatory markets (US/EU).
• Thorough knowledge on exhibit and validation philosophy and should have scientific evaluation methodology.
• Process development skills and handling of equipment's ensuring safety principles.
• Hands on experience on equipment's and planning of exhibit batches.
• Strong technical presentations skills.
• Good Communication and problem solving skills.
• Should be assertive, proactive and self-driven.
• Sound knowledge on quality management systems.