Technical Reviewer

Cambrex • Niwot, CO

236d • $84,200 - $97,620

About The Position

The Technical Reviewer will work independently to provide a technical review for small and large molecule development and testing data in compliance with cGMP/cGLP standards and FDA / EU regulations. This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine laboratory tasks. This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed within the specified timeframes. Ability to work within a dynamic and fast paced environment.

Requirements

• BA/BS in Life sciences field is required.
• 4+ years of relevant experience in a CDMO and/or pharmaceutical environment.
• Experience in laboratory testing, preferably in the pharmaceutical or biotechnology industries.
• Strong knowledge and understanding of LIMS and Empower.
• Skilled in MasterControl, Trackwise and/or other QMS software applications, preferred.
• Strong knowledge and experience with a wide variety of analytical techniques such as ICP-MS, Particle Size, XRD, DSC/TGA, NMR.
• Good understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.
• Understanding of microbes (e.g., bacteria, viruses, and fungi) and molecular assays, preferred.
• Knowledge of Environmental Monitoring and Clean Utility Monitoring, preferred.

Nice To Haves

• Good analytical and problem-solving skills with proven ability to think critically and to focus on details of execution.
• Experience in trending analytical data (method data and product data) is preferred.
• Experience in trending environmental monitoring/clean room services data is preferred.
• Experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is preferred.
• Good technical writing skills.
• Experience authoring and reviewing technical documents such as reports and protocols.

Responsibilities

• Perform an independent technical review of all analytical GxP testing performed on starting materials, raw materials, intermediates, drug substance, drug product, packaging components, customer samples, stability study samples, in-process testing/checks, etc. for completeness, accuracy and compliance.
• Good understanding of analytical laboratory practices and able to apply quality assurance principles to the review process to ensure data is scientifically sound and compliant with all regulatory body requirements and local procedures.
• Review technical documents such as protocols and technical reports for qualification/validation and stability activities, as required.
• Work with analyst and laboratory management to conduct and document laboratory investigations.
• Provide accurate and timely delivery of data review and report any findings to the appropriate departments to support overall project due dates.
• Escalate issues which may impact timeline to laboratory and quality management.
• Ensure all issues/documentation is complete prior to approval.
• Participate in department/client meetings, collaborate, and cooperate to achieve cross-functional improvements and business goals.
• Participate in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site's needs.
• Effectively resolve quality issues and concerns in a timely manner.
• Effectively coordinate and organize tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy and competency.
• Create strong and effective working relationships with Quality team, colleagues, and clients.

Benefits

• Healthcare
• Life insurance
• Planning for retirement
• Competitive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree