Sr Executive, Form Dev-ARPL-FD AR

Job Summary

• 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 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.
• Responsible for assisting in execution of early development, scale-up, stability, submission, placebo batches to develop new and modified product formulations, and for packaging – filling and/or sealing – quality pharmaceutical products in a variety of finished goods formats. The Technician works and ensures that all operations are performed in accordance with applicable procedures.  The person is an expert at basic skills in Formulation Development.

Job Responsibilities

1. Executes process evaluation, experimental, optimization, Bio / Submission batches and scale-up trials and batches as per instructions.
2. Weighs, mixes, screens and blends raw materials to produce experimental trials, pilot and small-scale batches for compressed, enteric coated, and film coated tablets, capsules, pellets, powders, liquids and others as required.
3. Dismantles, cleans, sanitizes and assembles, as required, formulation development rooms and equipment according to established SOPs and Technical Manuals to ensure GMP compliance and meet schedule requirements.
4. Performs in-process quality tests on trials and production batches for weight, hardness, thickness, friability, disintegration, etc. as required.
5. Delivers in-process samples to the designated area. Maintains in-process testing lab.
6. Completes and signs off all process documentation required during the execution of a batch.
7. Recognizes out of normal situations and uses conventional problem-solving skills to identify the root cause and troubleshoot problems, provides feedback to the supervisor, and seeks assistance as required.
8. Recommends modifications to methodology used in trials and optimization where there are opportunities to improve processes / procedures.
9. Reviews trial and batch documentation for correctness and completeness before forwarding to Supervisor.
10. Deducts raw materials from inventory where required.
11. Participates in operating the current Packaging equipment within specifications.
12. Conducts basic troubleshooting of the entire Packaging operations.
13. Works as a member of a team to achieve all outcome.
14. Works in a safe manner collaborating as a team member to achieve all outcomes.
15. Responsible for development and design of formulations for multiple products selected for development & conducting meeting with multidisciplinary teams.
16. Conducts relevant patent searches on formulations. Reviews scientific literature and makes recommendations for formulation development strategies.
17. Attends appropriate trainings, seminars, and presentations to maintain expertise in formulations and related areas.
18. Communicates with buyers and peers to ensure that APIs, excipients, tooling etc. are available for the project in required quantities, as and when needed.
19. Liaises with the plant operation supervisors and scheduler to ensure that experimental trials / registration batches are planned and executed in a timely manner.
20. Liaises with the documentation groups to ensure that early development trial documents, process evaluation and process optimization documents required for execution.
21. Coordinates with lab for sample requirement and provides timelines for testing of samples.
22. Coordinates with documentation teams for timely manufacturing and packaging document availability.
23. Coordinates with documentation for timely regulatory submission documents.
24. Possesses a detailed understanding of the theoretical principles for major manufacturing and a working knowledge of the equipment used in the manufacturing processes and ensures successful execution of experimental trials / registration batches on floor.
25. Responsible for investigating issues with formulations & processes. Uses advanced techniques to identify root cause of issues and plan a course of action for further investigation and corrective action as required.
26. Works as a member of a team to achieve all outcomes.
27. Works in a safe manner collaborating as a team member to achieve all outcomes.
28. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion.
29. Ensure personal adherence to all company policies and programs.
30. All other relevant duties as assigned.

Job Requirements

• Education
  • Diploma or in Chemistry, Pharmaceutical Technology, Engineering, or related science would be an asset.
    
    
• 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.
  • Strong verbal and written English communication skills.
  • Experience using computers, preferable in MS Office (Word, Excel, PowerPoint, Outlook).
  • Well-developed interpersonal and team skills.
  • Knowledge of GMP, GLP, GDP, Safety, FDA and TPD guidelines.
  • Multi-tasking and project management skills.

• Experience
  • 6-8 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.