Job Description
Our client, a global pharmaceutical manufacturer with strong pipeline of products in drug development and commercial manufacturing, now seeks a Senior Analytical Development Scientist who will operate within their R&D function and reporting to Manager.
The successful candidate will lead development of analytical methods for characterisation of drug substance/drug product candidates from proprietary pipeline. Additionally, you will perform phase appropriate method qualifications and validations and execute transfer to other departments/sites.
This hire will lead specified project aspects, working cross-functionally and representing the department on such teams in a matrix environment. Ability to lead, effectively communicate and positively influence within such teams is required.
Responsibilities for Senior Analytical Development Scientist:
Plan, Investigate and troubleshoot complex technical problems and participate in laboratory investigations without supervision.
Preparation and testing of proprietary drug product samples in accordance with written procedures and best practice with a focus to deliver the RandD pipeline.
Thoroughly make detailed observations, analyse data, interpret results and exercise appropriate technical judgment in the design, execution and interpretation of experiments.
Author GMP and technical documents e.g. SOPs, Validation reports etc.
Accurate and timely recording of all information pertinent to the task being performed in the relevant electronic notebooks, equipment logbooks or laboratory worksheets.
Peer review routine and complex data.
Provide a degree of coaching to junior staff.
Ensures all instruments are maintained and calibrated in an operational state.
Plan day to day activities and meet project target goals.
Comply with all aspects of cGMP, Safety and Environmental regulations and Company policies, which impacts on doing the job and safety within the laboratory adhering to all safety/dress code procedures.
Requirements for Senior Analytical Development Scientist:
Bachelor's degree (Analytical Chemistry/Physical Organic Chemistry/Pharmaceutical sciences or related field).
10+ years of relevant experience. Typically decreasing level of experience required if Masters (7+ years) or PhD (5+ years) level qualification.
High practical and theoretical knowledge of pharmaceutical analysis particularly in chromatographic techniques that includes HPLC.
Proven experience with cGMP requirements and other FDA regulatory requirements associated with analytical testing of pharmaceutical products.
Excellent interpersonal, collaborative, communication (written and verbal) and time-management skills are essential.
Proven track record in current and previous roles, with demonstratable focus on results and performance driven.
Resilient, flexibility and adaptability to changing needs and work product requirements.
Proactive, innovative with good problem-solving skills.
For further details, contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter