Scientist 2 - Product Characterization

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

About The Position

At MilliporeSigma, as a Scientist 2 - Analytical Development, you will be the primary scientific resource for a given study with the Product Characterization Laboratory in our Biologics department. The Scientist will act as subject matter expert in analytical method development/validation and feasibility/transfer for testing required to manufacture clinical and commercial products. 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.