- Leads, coordinate, manage and execute NPI transfer projects. Acts as a subject matter expert in method transfer and validation and for complex analysis using various wet chemistry and instrumentation techniques.
- Prepare transfer plans, conduct required testing, analyze data, trouble shooting and work closely with R&D and QC analysts and new product development team to keep track of the method transfer process and act as facilitator if necessary to meet all the quality requirements and deadlines.
- Leads the validation of test methods for pharmaceutical raw materials, in process samples and finished products.
- Track the progress of analytical method validation and transfer projects, openly communicate updates, risks and mitigation strategies to stakeholders and management.
- Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
- Assess analytical methods and perform gap analysis on analytical method validations for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from team to ensure compliance.
- Author, review or approve analytical method validation and transfer protocol and reports ensuring sound scientific design, compliance with ICH, pharmacopeia and regulatory guidelines, industry best practices, and Bimeda’ s internal procedures.
- Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments and conducts complex analytical testing for NPI and investigate when required.
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Coordinate transfer of information and materials related to analytical method validation and transfer
- Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
- Evaluate global documents against site specific procedures and update the site procedure accordingly.
- Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
- Generates change requests and all required analytical documentation, and routes documents for review and approvals.
- Strong collaboration, communication and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across site and functions.
- Collaborates with colleagues and external partners to achieve individual and department goals.
- Other duties as assigned.
- 5-7 years of work experience in an Analytical testing lab in pharmaceutical
- BSc / MSc degree in Chemistry or related science
- Subject Matter expert in Analytical chemistry with experience utilizing the following equipment: auto-titrator, pH, conductivity meter, TOC, UV, IR, GC, HPLC / UPLC required
- Excellent project management skills and the ability to track multiple programs and projects simultaneously.
- Excellent communication skills with stakeholders, external partners and management.
- Knowledge of ICH and regulatory guidelines, pharmacopeia, and industry best practices for analytical method validation and transfer.
- Understanding of GMPs and requirements for working in GMP laboratories.
- Good investigational skills, including design of experiments and establishing appropriate criteria. Experience with statistical data analysis and software.
Core Behaviours, Skills & Abilities:
- High integrity. The right candidate ensures adherence to procedural guidance and raises any identified issues to the QC Supervisor.
- Excellent attention to detail – able to thoroughly document and review work, while consistently identifying discrepancies or errors.
- Committed to teamwork, and to achieving team targets.
- Motivated and challenges self by setting and achieving goals.
- Ability to organize and prioritize work.
- Excellent communication skills both verbally and written - expresses own views clearly and constructively & confirms understanding.
- Acts with purpose, urgency, reliability and professionalism.
- Engages in good change initiative (CI) behaviour - open to new ideas & identifies areas for improvement.
- Versatility to perform a wide variety of tasks, showing flexibility in work assignments and organization.
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
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com