Senior Associate Scientist - Product Characterization

Job description

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Senior Associate Scientist - Product Characterization

Your Role:

 

The Senior Associate 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 Senior Associate Scientist is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations. Perform analysis of testing performed within the Product Characterization Laboratory.  May act as subject matter expert in bioassay development for studies performed in the Product Characterization laboratory.  Will develop/validate and perform GMP methods.

 

·  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:

Minimum Requirements:

·  Ph.D. in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 1+ years working laboratory experience – OR –
·  Master’s degree in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 2+ years working laboratory experience – OR –
·  Bachelor’s degree in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 5+ years working laboratory experience

 

Preferred Requirements:

·  Relevant working knowledge and Experience with development of assays with some or all the following technical disciplines;
·  Flow Cytometry
·  Host Cell Protein ELISA
·  ELISA
·  Cell based assay experience
·  SPR Platforms
·  Developing and validating assays in GMP environment
·  Usage of following software/equipment:
·  SoftMax Pro
·  BD Facs Diva
·  Cytiva/GE Biacore (T200/8K system)
·  Usage of automated cell counter

 

RSRMS

Job Requisition ID: 210688

Location: Rockville

Career Level: C - Professional (1-3 years)

Working time model: full-time .buttontextf748fab0b60d052d a{ border: 1px solid transparent; } .buttontextf748fab0b60d052d a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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