Senior Associate, AD
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Senior Research Associate performs GMP testing in support of manufacturing which includes environmental monitoring testing, utilities monitoring testing, inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods and standard test methods. The Senior Research Associate also performs GMP testing as required to support of release and stability of API and finished drug product. He/She maintains laboratory cleanliness and performs preventative maintenance on laboratory equipment per established procedures.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
· Perform general laboratory duties including, but not limited to:
• Clean laboratory areas/glassware
• Monthly equipment calibration/qualification
• Transfer and dispose of biohazard waste and expired chemicals
• Receipt and documentation of samples
• Monitoring of Controlled Temperature Units
• Review and file completed raw data
• Ship samples and monitor test results produced by contract testing laboratories
• Procure lab supplies/service and enter service receipt in SAP
· Proficient in performing laboratory testing including, but not limited to:
• Examination of viable plates for microbial growth
• Total Microbial Count Testing
• Sterility Testing
• Conductivity Testing
• Growth Promotion
• Microbial Identification
• Sample and inspect raw materials in compliance with GMP/ANSI standards
• pH Testing
• Osmolality Testing
· Proficient in collection of aseptic environmental samples:
• Sampling of utilities systems (Water systems, and gas delivery systems)
• Aseptic sampling of the manufacturing suites
· Perform staff training at the Qualified Trainer level
• Perform peer review (calculations, logs, etc.)
• Administer Gowning Certification
• Capable of understanding, interpreting, and implementing regulatory requirements / guidelines for environmental monitoring and contamination control, including but not limited to:
• ISO, USP/EP, Eudralex Annex 1, FDA Guidance for Industry ·
• Prepare and review presentations, reports, and standard operating procedures (SOPs) ·
• Lead or present at project meetings or cross functional team meetings as needed ·
• Identify and implement continuous improvement opportunities to reduce non-value added work or complexity ·
• Ensure compliance with cGMP and Good Documentation Practices ·
• Analyze results and prepare trend data to support routine review of operations and identify adverse events ·
• Contribute to maintaining regular laboratory and system functions for the group, including maintenance of paper, electronic, and hybrid data supporting QC Environmental Monitoring functions ·
• Initiate and support Quality Systems work such as Deviation, Change Control and CAPA activities ·
• Use sound judgment to resolve problems and make routine and advanced decisions independently ·
• Provide logistical support and technical knowledge during internal and external inspections
• Participate on response teams to address observations and recommendations made during inspections
Behavioral / Cultural Responsibilities: ·
• Acts independently to determine strategy for completing projects and complex assignments ·
• May provide guidance to lower-level personnel · Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought
• Effectively build and maintain working relationships between QC Environmental Monitoring and support departments
• Actively participates in self-development
• Follows through on commitments
• Detail oriented – Able to complete required tasks and associated documentation with minimal error
• Exercises good decision quality by utilizing available resources to evaluate requirements, risks, and benefits
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s Degree in a scientific discipline preferred or equivalent related experience in cGMP biologics/pharmaceutical Quality Control with at least 5 years of relevant experience or Master’s Degree with a minimum of 3 years of relevant experience
• Ability to follow SOPs and comply with cGMPs; generate SOPs
• Familiarity with global pharmacopeias and monograph testing
• Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics
• Requires experience with executing raw material sampling and testing
• Experience working in a pharmaceutical testing environment
• Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.