Scientist 2 - Stability

Merck • Rockville, MD

5d

About The Position

As a Stability Scientist 2, your activities will support stability programs for a wide set of clients spanning diverse types of drug substances, drug products, intermediates and critical raw materials. The Stability Scientist 2 will have oversight of active stability programs and is required to make scientific observations, maintain detailed workbooks/ documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of MilliporeSigma services, technical principles and applications. For GLP studies, perform all aspects of the role of Study Director with overall scientific responsibility for the study design, interpretation, and reporting of study results.

Requirements

• Ph.D. in scientific discipline (e.g., Chemistry, Biochemistry, Biology, etc.) with 1+ years of scientific/laboratory experience
• MA/MS in scientific discipline (e.g., Chemistry, Biochemistry, Biology, etc.) with 4+ years of scientific/laboratory experience
• BA/BS in scientific discipline (e.g., Chemistry, Biochemistry, Biology, etc.) with 6+ years of scientific/laboratory experience

Nice To Haves

• Degree in Analytical Chemistry
• Broad working knowledge of analytical chemistry, preferably applicable to Quality Control testing within Product Characterization lab.
• Expert in HPLC, CE-SDS and cIEF
• Previous experience managing stability programs
• Strong knowledge of GMP practices, compendial regulations, quality assurance, and compliance standards
• Proficient in using Minitab and Empower, and preferably 32 Karat and highly, technically competent
• 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 and highly collaborative as well as independent
• Demonstrates a high level of initiative and leadership capabilities
• Effective coaching and training skills for complex and highly technical work

Responsibilities

• Strong Biostatistics background for evaluating Stability data trending and generation of trending reports
• Oversight and generation of stability SOPs and protocols
• Revise stability protocols, reports, and SOPs as needed and oversight and management of current stability protocols
• Ensure accuracy of interim and final stability reports
• Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during stability study
• Liaise with labs to understand full assay offerings & provide knowledgeable suggestions to clients to expand their stability testing selections per their specified needs
• Excellent communicator with technical expertise to lead discussions with clients and regulators.
• Must have a strong scientific background to speak on a wide spectrum of assay offerings alongside Stability specific knowledge
• Maintains complete and comprehensive records for study integrity
• Makes detailed observations, documents results and performs data analysis
• Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, Minitab, etc.)
• Creates/ revises SOPs, laboratory records and other related documentation (General Change Controls, CAPAs, audit findings) as assigned
• Performs training of laboratory personnel as needed/ assigned
• Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment

Benefits

• medical, vision, and dental insurance
• life insurance
• disability insurance
• a 401(k) matching program
• paid time off
• paid holidays
• short-term or long-term incentive compensation, including, but not limited to, cash bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree