Job Summary:

• Develop and implement new analytical methods for bio-materials including synthetic and natural polymers.
• Develop, optimize and qualify characterization methods for products in-process and release test methods.
• Conduct diverse analytical methods, including colorimetric assays (chemical/biochemical).
• HPLC/GC and physical assays.
• Transform R&D methods into qualified QC tests.
• Analytical method validation (Protocols/Reports writing and executing).
• Write work instructions and other technical documents.
• Document all work according to GLP/ISO.
• Work in close collaboration with both R&D and QC departments.
• Report to VP R&D.

Skills on Resume:

• Analytical Method Development (Hard Skills)
• Characterization Methods (Hard Skills)
• Analytical Techniques (Hard Skills)
• Quality Control (QC) Transformation (Hard Skills)
• Method Validation (Hard Skills)
• Documentation Skills (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Collaboration (Soft Skills)

Job Summary:

• Participate in Sales Meetings and in the negotiation phase with the Prospect or Customer.
• Support Sales Team in preparing Proposals (e.g. interpretation of needs, choosing the right Tests, adjustment Test Parameters, etc.).
• Help Sales Team to identify new business for existing Customers and identify a retention strategy.
• Provide his/her expertise for Quotation Technical Validation (QTV).
• Configure the Account and Order preferences.
• Interpret and make sure Results are correctly reported.
• Validate Analytical Reports.
• Answer technical and regulatory questions.
• Validate the Invoices.
• Coordinate internally all technical services for Customers.

Skills on Resume:

• Sales and Negotiation Skills (Soft Skills)
• Proposal Preparation (Hard Skills)
• Business Development (Soft Skills)
• Technical Validation (Hard Skills)
• Account and Order Configuration (Hard Skills)
• Data Interpretation (Hard Skills)
• Report Validation (Hard Skills)
• Technical Support and Coordination (Soft Skills)

Job Summary:

• Instrumental in developing a culture of quality and critical review across QC, Stability and Validation in compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Responsibility for the dissemination of information relating to quality to the wider business.
• Overall management of all laboratory staff, ensuring they are properly trained, with proper guidance provided where necessary, including preparation of budgets.
• Ensure change is managed appropriately and reported, trended, and reviewed.
• Ensure that data integrity principles are embedded in the culture of laboratory operations.
• Manage and review non-conformities including user complaints and internal non-conforming events.
• Responsible for the oversight of a document control system for all laboratory SOPs.
• Develop and produce regular reports for laboratory meetings and on an ad-hoc basis.
• Ensure that the laboratories are safe working environments for all laboratory employees.
• Generate metrics to track and support laboratory performance.
• Have strong, working knowledge of the pharmaceutical industry, including GMP, GDP and GLP.
• Have people Management experience.
• Extremely capable in metric generation, data trending and document control processes.

Skills on Resume:

• Quality Management (Hard Skills)
• Communication Skills (Soft Skills)
• Leadership and Management (Hard Skills)
• Change Management (Hard Skills)
• Data Integrity (Hard Skills)
• Problem Solving (Hard Skills)
• Document Control (Hard Skills)
• Safety Management (Hard Skills)

Job Summary:

• Supervises the day to day operations for assigned area.
• Ensures all staff members are fully trained.
• Participates in and supports client visits, audits and inquiries to ensure complete fulfillment of requests and interests.
• Recruits, trains, develops and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to moderately complex issues in area of expertise.
• Ensure that the analytical chemistry laboratory is maintained in an audit ready state
• Review data for accuracy and completeness, oversee training of team members, write technical documents (e.g. reports, protocols, test procedures, SOPs, etc.)
• Supervise compendial method verifications and method transfers, and manage quality events.
• Include training, BMRAM, Master Control, Quality Event follow up and other tasks in team member schedules.
• Create daily schedules with prioritized tasks for each team member.
• Hold daily team huddles to assess resources, workload and finalize plans.
• Regularly inspect work to ensure quality and pace of work.
• Delegate work to team members and follow up to ensure accuracy and on time completion.

Skills on Resume:

• Supervisory Skills (Hard Skills)
• Training and Development (Hard Skills)
• Client Interaction (Soft Skills)
• Technical Expertise (Hard Skills)
• Documentation and Compliance (Hard Skills)
• Quality Management (Hard Skills)
• Organizational Skills (Soft Skills)
• Analytical and Reporting Skills (Hard Skills)

Job Summary:

• Develop and continuously improve processes of analytical services including sample tracking, test delegation, data review, report drafting, data storage, instrument maintenance and calibration, etc.
• Manage general lab operations including purchasing supplies, maintaining and calibrating equipment, establishing and organizing instrument footprints in the lab, etc.
• Represent the Analytical Services group in meetings with collaborators to help on interpretation of data, selection of test methods, resource allocation and priority setting, etc.
• Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release and stability testing of drug substance and drug products
• Ensure high-quality and compliant documentations of tests in a timely manner
• Draft and review SOPs, test records/forms, various analytical protocols and reports
• Train new analysts of test methods
• Enforces all laboratory safety, security and housekeeping policies and procedures.
• Supporting compendial testing (USP, EP, JP, ACS, FCC, etc.) for wet chemistry, chromatographic, and spectrophotometric analyses.
• Performing root cause analysis for quality events.
• Review, compile, and analyze information to prepare reports.

Skills on Resume:

• Process Improvement (Hard Skills)
• Lab Operations Management (Hard Skills)
• Collaboration and Communication (Soft Skills)
• Analytical Testing (Hard Skills)
• Documentation Management (Hard Skills)
• SOP and Protocol Development (Hard Skills)
• Training and Development (Soft Skills)
• Regulatory Compliance (Hard Skills)