Scientist 2 - Stability

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 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.

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

Who You Are

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 job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.