Work Location: Rockville, Maryland Shift: Department: LS-LS-TGCADA US OPS IMMUNO Recruiter: Genie Hooper
This information is for internals only. Please do not share outside of the organization.
Your Role
At MilliporeSigma, as the Scientist 1, you will be the primary scientific resource for a given study with the Product Characterization Laboratory within the overall Biologics department. The Scientist will act as subject matter expert in bioassay development for studies performed in the Product Characterization Lab and will oversee a wide variety of safety testing required to manufacture clinical and commercial products. You will be responsible for ensuring current regulatory requirements are met and the technical & regulatory needs are appropriately met, effectively interpreted, and then communicated to the client and performing analysis of testing performed within the Product Characterization.
Performs testing in accordance with SOPs and regulations (cGMP and GLP)
Act as subject matter expert (SME) for specific defined area(s) of the business.
Applies laboratory techniques and skills to complete experiments designed to address a variety of specific problems.
Independently applies basic scientific principles in the design of experiments and the development of assays.
For GLP studies, acts as Study Director.
Maintains complete and comprehensive records for study integrity.
Makes detailed observations, documents result and performs data analysis.
Operates and maintains lab equipment as required by SOPs and testing procedures.
Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
Utilizes problem solving/ trouble shooting skills.
Communicates deviations/ events, progress and interim results to Study Management.
Leads the completion of event records.
Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
Maintains a working knowledge of lab procedures and assays.
Creates/ revises SOPs, laboratory records and other related documentation as assigned.
Writes technical reports for internal use and collaborates on papers for external use.
Performs training of laboratory personnel as needed/ assigned.
Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment.
Acts as key driver/ champion on project teams.
Complies with company health and safety regulations and procedures.
Who You Are
Minimum Qualifications:
Ph.D. in scientific discipline (i.e., Immunology, Biology, Biochemistry, etc.) with 1+ years of experience in a laboratory environment - OR -
Master's degree in scientific discipline (i.e., Immunology, Biology, Biochemistry, etc ) with 3+ years of experience in a laboratory environment - OR -
Bachelor's degree in scientific discipline (i.e., Immunology, Biology, Biochemistry, etc ) with 5+ years of experience in a laboratory environment
6+ months experience with Flow Cytometry (potency, titer, viability or identity) -OR- 6+ months experience with Elisa
Preferred Qualifications:
Experience with some or all of the following technical disciplines
Molecular qPCR and/or ddPCR
Cell-based bioassays
Experience with industry GxP compliance
Intermediate skills in applicable computer programs (Softmax, PLA, or FACSDiva)
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
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
Highly, technically competent
Pay Range for this position - $49,500 - $148,900
Our ranges incorporate all levels and career types available within this specific role, and are derived from 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.