Key Role Specific Requirements:
- Works within the formulation team to assist with formulating new products, from development to commercialisation, within defined company, industry, and regulatory parameters to support new drug submissions
- Responsible for the testing of R&D products during formulation development, investigations and informal stability campaigns as required.
- Adheres to project timelines in accordance with marketing priorities, sets milestones/critical path and ensures on time project completion
- Assist in the establishment and justification of specifications for new and/or reformulated products based on available data and scientific judgement.
- Assists with the preparation of product registration documentation to meet regulatory requirements
- Documents analytical test results and in-process test data as they occur in log books or reports as required.
- Assists with the peer review of relevant data as requested.
- Communicates and collaborates effectively with the cross functional departments and CMOs to support tech transfer and process validation activities
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs)
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies for the Role:
- ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this
- CRITICAL THINKING – is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.
- INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
- DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
- FLEXIBILITY -The ability to be open to different and new ways of doing things; willingness to modify one’s preferred way of doing things. Is able to see the merits of perspectives of others than his/her own.
- Minimum of 1 year experience within an a formulation development environment
- BSc/MSc in Chemistry/Pharmacy or other related discipline
- Basic knowledge of formulation development of both sterile and non-sterile dosage forms including parenteral, gel/pastes, pour-ons and intramammary products
- Excellent attention to detail.
- Ability to organize and prioritise project work based on the company’s needs.
- Understanding of cGMP guidelines, FDA and EU regulations related to the pharmaceutical industry
- Ability to work as part of a team in a dynamic environment.
Understanding of QbD methodologies
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.