Scientist, Product Characterization
A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Perform analysis of testing performed within the Product Characterization Laboratory. May act as subject matter expert in Analytical Chemistry for studies performed in the Product Characterization laboratory. Will develop/validate and perform GMP methods.
PURPOSE OF THE POSITION
The Scientist will oversee a wide variety of safety testing required to manufacture clinical and commercial products. The Scientist will be the primary scientific resource for a given study with the Product Characterization lab within the overall Biologics department. The Scientist is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations.
ESSENTIAL JOB FUNCTIONS
- Provides day to day technical support to the laboratory.
- Performs analysis and interpretation of data.
- Prepares/ reviews protocols and final reports.
- May serve as study director and ensures timely initiation and completion of all studies.
- Ensures testing is performed in accordance with SOPs and regulations (cGMP and GLP) for custom/non routine and new services.
- Participate and/or drive assay development/ assay transfer and/or assay validation activities.
- Justify business needs and drive implementation of new services.
- Operates and maintains lab equipment as required by SOPs and testing procedures.
- Responsible for resolving deviations/ completing 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 high level knowledge of lab procedures and assays.
- Responsible for creating revising SOPs, laboratory records and other related documentation.
- Coaches/ trains others on developing and enhancing day to day laboratory techniques.
- Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.
- Regarded as a subject matter expert (SME)
- Provide technical advice and support for internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences.
- Promote a culture of continuous improvement within Biologics; act as champion on initiatives and/or projects to drive improvement in quality and / or client service.
- Contributes/ authors scientific publications and presents at conferences/ seminars.
- Leads projects that cross multiple disciplines.
- Complies with company health and safety regulations and procedures.
- Performs other duties as assigned
Who You Are:
• Ph.D. in scientific discipline with 2 or more years of relevant experience
• MA/MS in scientific discipline with 4 or more years relevant experience
• BA/BS in scientific discipline with 6 or more years relevant experience
- Relevant working knowledge and experience in Analytical Chemistry executing and overseeing technical projects and/or related studies
- Experience leading and/or supervising staff in a laboratory setting
- Experience with some or all of the following technical disciplines;
- Liquid Chromatography
- Mass Spectrophotmetetry – performing the following tests;
- Molecular weight
- Peptide mapping
- Glycan Profiling
- N-Terminal Sequencing
- UHPLC methods
- Capillary Electrophoresis Methods (CE, cIEF)
What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.