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CHEManager International · 18 hours ago

Scientist 2 - Product Characterization

Rockville, MD

Full-time

Onsite

Mid, Senior Level

$75K/yr - $131K/yr

3+ years exp

MilliporeSigma is a global leader in science and technology, seeking a Scientist 2 for their Product Characterization Laboratory in the Biologics department. The role involves acting as a subject matter expert in analytical method development and validation, ensuring compliance with GMP requirements, and leading the execution of studies related to clinical and commercial product testing.

Responsibilities

Understand GMP requirements for validation/transfer and documentation

Act as subject matter expert (SME) in analytical methods and provide guidance to analysts and study managers

Apply laboratory techniques and skills to complete experiments designed to address a variety of specific problems

Lead development/validation and feasibility/transfer of analytical methods and ensure timely initiation and completion of studies

Prepare/ review protocols, reports, SOPs, laboratory records, tech specifications, and other related documents

Execute analytical methods in the lab for assay development/validation, feasibility/transfer

Perform testing in accordance with SOPs and regulations (cGMP)

Transfer GMP assays to the routine team and provide training to the analysts, study managers, report writers and QA

Operates, maintains lab equipment as required by SOPs and testing procedures

Utilize applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc)

Lead general change control and resolve deviations by completing event records

Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment

Ensure current regulatory requirements and technical needs of internal and external clients are appropriately met

Maintain strong communication skills to effectively interact with internally and externally stakeholders

Engage directly with clients

Performs other duties as assigned

Qualification

Analytical method developmentGMP requirementsLiquid ChromatographyMass SpectrometryCapillary ElectrophoresisCompendial assaysMethod development experienceLeadership capabilitiesCoachingTrainingComputer skillsCommunicationTime management

Required

Ph.D. in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 3+ years relevant experience -OR-

Master's Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 5+ years relevant experience -OR-

Bachelor's Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 7+ years industry experience

Preferred

Experience with some or all of the following technical disciplines: Liquid Chromatography (SEC, RP, IEX, etc.), Mass Spectrometry (Intact Molecular weight, Peptide mapping, Disulfide mapping, Glycan Profiling, N-/C-Terminal Sequencing), Capillary Electrophoresis Methods (CE-SDS, cIEF), Compendial assays, etc

Broad working knowledge of filed and experience with relevant laboratory practices, techniques, equipment, materials and mathematical calculations

Intermediate skills in applicable computer programs

Experience of method development in a pharmaceutical laboratory or similar field

Excellent verbal and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc

Excellent time management skills

Demonstrates a high level of initiative and leadership capabilities

Effective coaching and training skills for complex and highly technical work