Principal Analytical Development Technical Specialist, API E
|Contact Name:||Larry O’Leary|
Our client, a blue-chip multinational Biopharma company based in Munster region, now seeks a Principal Analytical Development Technical Specialist for the API External Manufacturing QC Laboratory in the development of MABs. This technical position will ensure that the analytical testing of products at multiple contract manufacturing (CM) sites meets both company and external requirements and is executed consistently to predetermined standards. This position may require up to approx. 20% of international travel.
The successfully candidate will work in a fast-paced role, managing multiple competing project activities, at multiple CM sites. This hire represents the quality laboratories on cross-functional post-launch process optimization teams. Additionally, they will work closely with development to ensure robust analytical control strategies are established in QC for the molecules they support. Note: this hire may perform non-routine lab work in support of this.
Main Responsibilities: this hire will have responsibility for reviewing data released by the contract manufacturer to ensure it meets expectations, reviews deviations for trends, reviews and/or releases stability data and leads the resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results.
Responsibilities for Principal Analytical Development Technical Specialist:
Technical review, interpretation, and release of data including release data from CM, stability, process validation, and reference standard characterization.
Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Guides CMs to perform root cause analysis investigations and develop solutions to prevent reoccurrence.
Develop investigational testing protocols and perform testing as required.
Contribute to annual product review and process validation as required.
Communicate effectively in both written and oral formats within the lab as well as with CMs and business partners.
Participates in internal/external audits as needed
Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
Method assessments, deficiencies and areas for improvement noted within the assessments.
Method validations (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in laboratory practices).
Provide laboratory support (e.g., method development, validation and method development work and implementation of method improvements for marketed products (including: laboratory work, training/transfer of new method to CM labs, change controls, and regulatory submissions).
Method transfers between QC labs and to CMs.
Oversee transfer of analytical methods for marketed products to CMs or other QC Labs.
Monograph review and implementation
Ensure consistent practices between global laboratories.
Effective management of multiple projects.
Requirements for Principal Analytical Development Technical Specialist:
Honours Bachelor Degree in a Science field related to the lab (e.g. Chemistry, Biochemistry, Biology).
5+ years’ experience supporting analytical & clinical development of monoclonal antibodies and/or manufacturing
Demonstrate proficiency in complex laboratory analysis in a cGMP laboratory, including; chromatographic, spectroscopic, and/or microbiological assays
Strong skills in making risk-based decisions and prioritization
Deep understanding of cGMP compliance requirements and regulatory expectations
Demonstrated accuracy and proficiency in analytical skills
Strong oral and written communication skills and demonstrated through documentation and presentation skills
Demonstrated experience with method qualification and validation
Previous experience working with contract laboratories in a cGMP environment
Training and demonstrated proficiency in root cause analysis methodology
Demonstrated strong problem-solving skills
For further details, please contact Larry on +353 (0) 1-2302400 / email@example.com
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
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