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Senior Analytical Science & Technology (AS&T) Manager


Paso Robles, CA 93446
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Job Details


The incumbent is the overall site lead for all activities required to complete the Analytical Method Transfer Exercise (AMTE) for the introduction of new Active Pharmaceutical Products (APIs) to the site and for the development of current API product methods; including the qualification of laboratory instruments, validation of new analytical methods, harmonization of analytical methods as required, improvement to robustness of current analytical methods as required and responsible for method verification/validation resulting from compendial reviews. Responsibilities will also include support for the AMTE when transferring API products to other Pfizer and/or Contract Manufacturing facilities.

Through collaboration with supporting Quality Control (QC) Laboratory and Manufacturing teams, the incumbent is responsible for providing oversight on analytical technology transfer activities (both into and out of the site), including but not limited to equipment qualification, process qualification, cleaning validation and associated site regulatory filing activities as well as providing subject matter expert (SME) technical guidance to the site and direction on laboratory investigations, manufacturing deviations, and where required customer complaint investigations requiring analytical support.

The incumbent will work with the QC Lead (Senior QC Laboratory Manager) to build the capabilities and systems to run a more robust Laboratory operation including the organization of long range manpower forecast and finite planning around the AMTE and routine QC Laboratory operations.

The incumbent will ensure that the quality systems in the Laboratory are continually audited and new requirements implemented, and Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs) and all related operations observe consistent compliance with current Good Manufacturing Practices (cGMPs), Pfizer Quality Standards (PQS) policies, site Standard Operating Procedures (SOPs) and regulatory guidance.



+ Develop and publish the annual Analytical Science & Technology (AS&T) project plan for all AMTE activities, method development and method validation activities taking into account resource capacity availability and budget requirements.

+ Plan and track the AS&T objectives, timelines, priorities, and resources.

+ Lead the AMTE process for new products coming from transferring sites, ensuring compliance with site SOPs, PQS policies and ICH guidance. Ensure the methods transferred are robust and rugged. Look to continually improve the AMTE process, including site Standard Work Plans (SWP's) and the capability and competence of AS&T team members.

+ Lead the development of new analytical methods and analytical method troubleshooting for existing raw materials, process intermediates, APIs and manufacturing plant cleaning samples to ensure method robustness. Develop expertise through analytical method literature, interaction with Pfizer Pharmaceutical Sciences (PharmSi) and Pfizer Global Technology Services (GTS) groups.

+ Develop analytical methods as required to support current and new product introductions, including the creation and validation of analytical methods for cleaning validation activities.

+ Mentor the AS&T team and QC Laboratory colleagues on analytical method troubleshooting, method development and validation activities. Also through the leadership of the site AS&T team, responsible for (but not limited to) process and equipment comparisons, raw material introductions, process development studies, cleaning processes development and validation gap analysis where required.

+ Expected to have the in-depth expert knowledge of the Pfizer PQS Systems as they relate to analytical method transfers and validations in relation to the development and transfer of APIs. Expected to also stay abreast of recent developments in major regulatory guidance's issued by the FDA, EMA etc, and proactively assess impact and changes required for the current operations.

+ Supports routine API manufacturing and supply by providing on going technical support on analytical methods to the Value Stream manufacturing Teams (VSTs) during manufacturing and cleaning operations.

+ Maintain a strong relationship with QC Lead (Senior QC Laboratory Manager) to ensure alignment on analytical capital expenditure.

+ Support and conduct training of the QC Laboratory team in new analytical methodology where required.

+ Support and conduct training of the QC Laboratory team in newly transferred and/or developed and/or validated analytical methods ahead of the commencement of mainstream manufacturing activities.

+ Maintain a contemporary understanding of the regulatory environment relating to analytical methodology and specifications.

+ Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.

+ Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and Continuous Improvement Projects (CIP). Using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.

+ Ensure laboratory automation is functional at all times and supports laboratory efficiency.

+ Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.

+ Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.

Job Relate Requirements:

+ Excellent knowledge of analytical chemistry, analytical method development and validation processes as they relate to the Pharmaceutical industry; including a strong and thorough knowledge and understanding of GMP, GLP relating to analytical method development and validation principles.

+ Good knowledge of analytical instrumentation, laboratory automation and production processes.

+ Excellent verbal, written and interpersonal communication and presentation skills.

+ Demonstrated ability to interact effectively with senior management, auditors and regulators.

+ Demonstrated leadership, management and customer service skills.

+ Effective problem solving skills.

+ Comprehensive knowledge of cGMPs and appropriate regulations.

+ Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.

+ Knowledge of six sigma, lean labs and standard work practices.

+ Experience in Empower software.

+ Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control and R&D Laboratories.


+ Planning and scheduling of AMTE activities.

+ Conducting AMTE activities.

+ Equipment Qualification related to AMTE and method development/validation activities where required.

+ Analytical Method development and validation activities for raw materials, process intermediates, APIs, manufacturing plant cleaning samples and API stability samples.

+ QC Laboratory operating budget and Capital expenditure; in conjunction with QC Lead (Senior QC Laboratory Manager).

+ Laboratory safety programs.

+ Regulatory and compliance requirements with respect to the AMTE activities and any analytical method development / validation activities.

+ Operational efficiencies and CIP promotion.

+ Overseeing stability programs.

+ Standard Operating Procedure (SOPs) development and review.

+ Annual Product Review Reports (APRR) with respect to analytical method development and validation.

+ Staff Development and Performance Review. Key Performance Indicators (KPIs) :

+ Safety Performance.

+ AMTE Project Milestones per schedule.

+ Compliance to cGMP for all AMTE transfer packages.

+ Safety performance, number of accidents/incidents, safety suggestions.

+ Compliance to cGMP/GLP standards, audit performance.

+ Budget performance.

+ AMTE and Laboratory testing cycle/standard testing lead times

+ Timely execution of laboratory projects within allocated budget and specifications. ORGANIZATIONAL RELATIONSHIPS: The incumbent will interact with the following site departments for AMTE product transfer activities (into and out of the site) and GMP laboratory operations and activities related to the development and validation of current analytical methods i.e. Manufacturing Operations Process Teams, Quality Control Teams, Quality Assurance Teams, and Tank Farm TeamsInteraction with Pfizer Pharmaceutical Sciences (PharmSi) and Pfizer Global Technology Services (GTS) groups for AMTE and method development and validation activity support. EDUCATION: Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy or Pharmaceutical Sciences.Familiar with the self-directed team concept; manufacturing operations applications; six sigma and lean principles and process improvement tools. EXPERIENCE :

+ Minimum 5-10 years of technical experience in Quality Control and/ or Research & Development laboratories within the pharmaceutical, food, chemical or process industries.

+ Minimum 3-5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead teams of professional staff.

+ Excellent knowledge of analytical chemistry, analytical method development and validation processes as they relate to the Pharmaceutical industry; including a strong and thorough knowledge and understanding of GMP, GLP relating to analytical method development and validation principles

The incumbent will have the following core competencies:

+ Excellent Contemporary Knowledge of Analytical Techniques both theoretical and practical

+ Project Management skills

+ Team Leadership skills

+ Communication skills

+ Strong Analytical skills

+ Organizational Skills

+ Report writing

+ Operational Excellence (Lean) skills

Flexi Work - Tuas (Singapore)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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