MS&T Manager

4 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Senior Scientist, Parenteral Drug Product MS&T, External Manufacturing:

My Biopharmaceutical client are looking to recruit a Senior Scientist, Parenteral Drug Product MS&T, External Manufacturing. The successful candidate will provide technical support for manufacturing of small molecule drug products at Contract Manufacturing Organizations (CMO's) in Europe. The individual will act as single point of contact for technical matters at the CMO and may perform Person in Plant duties (PIP) in support of commercial manufacturing activities.

This position will report into the Associate Director of Parenteral ExM MS&T and will be located in the Dublin office.

Key responsibilities include:


• Provide technical support and leadership to the External Manufacturing Organization (ExM) for manufacturing of Parenterals at Contract Manufacturing Organizations (CMO's).


• The individual will act as single point of contact for technical matters at the CMO and may perform Person in Plant duties (PIP) in support of commercial manufacturing activities.


• Ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX), etc to reduce supply risks.


• Employment of resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.


• Maintain current knowledge of technology to support successful operation of the ExM business unit.


• Execution of Process Owner Role at contract manufacturing site for a single or multiple products. This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO, identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews, and provide technical support to ensure compliance and security of supply - metrics review, investigation close-out, change control review, Annual Product Quality Review reviews and continuous improvement.


• Leadership or support of root cause analysis, impact assessment and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for DP manufacturing. Leads and coordinates change requests, sometimes across sites or functions.


• Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.


• Participation on various matrixed teams to drive technical process improvement strategies.


• Support operational management of CMO as per Virtual Plant Team (VPT) governance structure.


• Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.

Required Skills and Experience:


• Advanced knowledge in sterile drug product manufacturing (liquids, lyophilized products, suspensions).


• The role holder will have in depth understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP)), Environmental Health and Safety (EHS) aspects of drug product (DP) manufacturing, validation, quality systems, equipment innovations, upgrades, and instrumentation. Ability to work on own and as part of a team and to drive issues to resolution.


• Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.


• Experienced in statistical process analysis, including use of statistical software platforms (e.g. Minitab) to determine trends and variability across inter-batch data sets. Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.


• Highly proficient in strategic and analytical thinking, problem solving and rapid decision-making skills.


• Demonstrated capability in implementing challenging goals, objectives, and practices in a complex and ambiguous environment.


• Strong ability in negotiating and influencing without authority in complex, high impact situations.


• Strong presentation and communication skills, both oral and written. Recognizes own impact on others and positions messages by adapting communication or writing style as appropriate for the audience.


• Ability to work within and lead cross-functional technical teams, across multiple cultures.


• Demonstrated ability to build alignment with business partners including Procurement, Quality, and CMO stakeholders.

Qualifications:

· A bachelor's degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Advanced degree is preferred.

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