Research Executive - Formulation Development

Unichem Laboratories; North Goa; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Unichem Laboratories in Goa invites an experienced formulation development professional to lead scale-up, QbD/DOE based parameter finalization, and tech transfer for tablets, capsules and other dosage forms.

You will review batch manufacturing records, support regulatory submissions for US/EU markets, provide technical input for process qualification, and train cross-functional teams on new products and exhibit batches.

Qualifications

• Must have experience of formulation development in reputed pharma organizations.
• Exposure to tablets, capsules, pellets dosage forms for regulatory markets (US/EU).
• Knowledge of exhibit and validation philosophy and scientific evaluation methods.
• Process development skills with safe handling of equipment and exhibit batch planning.

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 recommendations if any.
• Review process qualification report and provide relevant recommendations if any.
• Perform gap analysis 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

Tablet & capsule handling

Regulatory market exposure (US/EU)

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.
• HandleOOS/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 equipments ensuring safety principles.
• Hands on experience on equipments 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.