Sr. Research Scientist, Formulation Development, R&D
Date: Oct 12, 2023
Location: Bangalore, KA, IN, 560099
About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
Responsible for developing solid oral dosage forms for assigned by leading development activities to support the product pipeline. This role will develop experimental approaches and will be responsible for analyzing scientific results fromexperiments. 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 drug product development. This position requires effective problem solving and resolution in designated day-to-day operations This role requires to collaborate 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.
- Responsible for development and design of formulations for products selected for development.
- Conducts relevant patent searches on formulations. Reviews scientific literature and makes recommendations for formulation development strategies.
- Responsible to carry out Preformulation studies, manufacturing prototype batches and do the formulation development based on QbD approach.
- Attends appropriate trainings, seminars and presentations to maintain expertise in formulations and related areas.
- Communicates with buyers and / or 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 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, process evaluation and process optimization documents that are required for execution are made available as and when required.
- Coordinates with lab for sample requirement and provides timelines for testing of those samples.
- Reviews and evaluates data (e.g. dissolution, assay, content uniformity) on trials, makes recommendations for bio/stability study batches, and communicates these recommendations with management / peers to get necessary clearance to proceed further.
- Liaises with the documentation groups to ensure that all master manufacturing and packaging documentation, batch documentation, and other related documents required for the project are made available as and when required.
- 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 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.
- Possesses a detailed understanding of the 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 the floor.
- Responsible for investigating issues with formulations & processes. Uses advanced techniques to identify the root cause of issues and plan a course of action for further investigation and corrective action as required.
- Provides scientific and technical expertise and performs consultations on issues regarding formulation to other members of Formulation and other departments within the company.
- 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: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance, Global Quality policies & procedures, Safety & Environment policies, and HR policies.
- All other relevant duties as assigned.
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 dosage forms, controlled release dosage forms, 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 Microsoft Office (Word, Excel, PowerPoint).
- 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.
5-7 years of working experience in a pharmaceutical development environment with related experience in formulation development of solid oral dosage forms, scale up and/or technology transfer.
Apply for this position here.
Keywords: Sr. Research Scientist, Formulation Development, R&D, pharmaceutical, dosage forms, formulation development, solid oral dosage forms, QbD, product development