Scientist 2 - Stability in Rockville, Maryland

Stability Scientist 2

Work Location:

Rockville, Maryland

Shift: No

Department: LS-AS-TGCAC US PC Ops Routine Analytical

Recruiter:
Genie Hooper

This information is for internals only. Please do not share outside of the organization.

Your Role:
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.

Purpose of the Position 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 Millipore Sigma 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.

Essential Job Functions:

• 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 versight 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

Minimum Qualifications:

• 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

AND

• 1+ years experience in a client facing role

Preferred Qualifications:

• Degree in Analytical Chemistry
• Strong experience working with clients
• Broad working knowledge of analytical chemistry, preferably applicable to Quality Control testing within Product Characterization lab. Looking for an 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

Pay Range for this position - $71,700 - $132,000 Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other…