Assistant Manager - Formulation Development

Job Description

Job Summary

• Responsible for developing solid oral dosage forms for assigned projects or product categories by leading development activities to support the company product pipeline.
• This role will develop experimental approaches and will be responsible for analyzing scientific results from experiments. Generating accurate, reliable data by following established procedures and practices to support product development.
• Responsible for formula optimization experiments and process optimization trials by employing the concept of Quality by Design (QbD) and create the design space, Identification of Quality Target Product Profile (QTPP), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs) and its effect on drug product Critical Quality Attributes (CQAs) during the initial drug product development stage.
• This position requires effective problem solving and resolution in designated day-to-day operations This role requires to collaborate & participate meetings with multidisciplinary teams to resolve complex product development issues. The role will ensure compliance with current Good Manufacturing Practices (cGMP), Apotex policies and Quality Systems, and all applicable regulatory agencies.

Job Responsibilities

• Responsible for development and design of formulations for multiple products selected for development & conducting meeting with multidisciplinary teams.
• Conducts relevant patent searches on formulations. Reviews scientific literature and makes recommendations for formulation development strategies.
• Responsible to carryout Preformulation studies, manufacturing prototype batches and do formulation development based on QbD approach.
• Attends appropriate trainings, seminars, and presentations to maintain expertise in formulations and related areas.
• Communicates with buyers and peers to ensure that APIs, excipients, tooling etc. are available for the project in required quantities, as and when needed.
• Liaises with the plant operation supervisors and scheduler to ensure that experimental trials / registration batches are planned and executed in a timely manner.
• Liaises with the documentation groups to ensure that early development trial documents, process evaluation and process optimization documents required for execution.
• Coordinates with lab for sample requirement and provides timelines for testing of samples.
• Reviews and evaluates data analytical/ technical data on trials, and makes recommendations for bio/stability study batches, and communicates recommendations with management / peers to get necessary clearance to proceed further.
• Applies Quality-by-design (QbD) principles to product development and tests the ruggedness of the formula by conducting suitable trials to study the impact of variations in the excipients within SUPAC guidelines / variations in manufacturing process parameters to recommend control strategy for CMAs and CPPs.
• Liaises with the documentation group to ensure that all scale up master manufacturing and packaging documentation and other related documents required for submission to regulatory agencies are made available as and when required.
• To prepare Pharmaceutical Development Reports and other documents required for regulatory submissions and technology transfer.
• Responsible for responding to deficiency queries from regulatory agencies in timely manner.
• Provides scientific and technical expertise and performs consultations on issues regarding formulation to other members of Formulation Development and other departments.
• Works as a member of a team to achieve all outcomes.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values:
• Integrity – We do the right thing, every time.
  • Teamwork – We achieve more together.
  • Courage – We face challenges head on.
  • Innovation – We power progress with bold ideas.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

Education

• Master’s degree or Ph.D. in Pharmaceutics or Pharmaceutical Technology or related science.

Knowledge, Skills and Abilities

• Excellent working and theoretical knowledge of different pharmaceutical solid oral dosage forms such as immediate release, controlled release & delayed release dosage forms
• Detailed understanding of the theoretical principles for major manufacturing processes and equipment.
• Excellent knowledge of excipient properties and their use in formulation development.
• Strong verbal and written English communication skills.
• Excellent organization and report writing skills.
• Experience using computers, preferable in MS Office (Word, Excel, PowerPoint, Outlook).
• Well-developed interpersonal and team skills.
• Ability to work independently and make responsible and accountable decisions.
• Knowledge of GMP, GLP, GDP, Safety, FDA and TPD guidelines.
• Multi-tasking and project management skills.

Experience

• 10-15 years of working experience in a pharmaceutical development environment with related experience in formulation development of solid oral dosage forms for regulated market, scale up and/or technology transfer.