Specialist II, Quality Assurance
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 Associate will perform a variety of analytical methods in support of product characterization and method development. The Senior Associate will design and executes laboratory experiments with a high degree of independence and troubleshoot unexpected experimental outcomes. He/she will also perform GMP testing as required in support of release and stability of API and finished drug product and contribute to maintaining a clean and safe laboratory environment.
Reasonable accommodations will be made to enable individuals with disabilities to
perform the essential functions.
- Participate in development, qualification, and validation of protein characterization assays, such as RP-HPLC, SEC-HPLC, AEX-HPLC, SDS-PAGE, Western blot, BCA, etc.
- Perform compendial methods such as pH, conductivity, osmolarity, etc.
- Routine analysis of in-process and release samples
- Perform routine maintenance, calibration and qualification of laboratory equipment and
- Write, revise, and maintain assay SOPs and worksheets, protocols, reports, instrument SOPs, and other documentation as needed
- Assist in maintaining inventories of chemicals, reagents, and reference materials
- Close attention to detail and the ability to multitask
- Analysis and interpretation of test results, identify deviations, and make appropriate recommendations
- Present data within the Analytical Development group
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 Chemistry or closely related scientific discipline with at least 5 years of relevant experience.
- Knowledge of and hands-on experience with HPLC methods; familiar with either Waters or Thermo HPLC system and their HPLC data process software such as Empower and/or Chromeleon; some Mass Spec experience is a plus.
- Ability to follow SOPs and comply with cGMPs; generate SOPs
- Possess a strong work ethic along with a solid organizational, time management, problem-solving, and interpersonal skills
- Demonstrated experience analyzing critical data and proactively solving problems
- Excellent written and verbal communication skills
- Good understanding of regulatory requirements, including FDA/EMA, GMP, ICH, USP/EP
- Ability to work with a high level of independence to design, troubleshoot, and execute experiments
- Experience working independently and thriving in a fast-paced environment
- Basic computer skills, including MS Word, Excel, PowerPoint
- Able to learn new skills quickly
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.
Job Type: Full-time
Pay: $110,000.00 - $130,000.00 per year
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Referral program
- Relocation assistance
- Tuition reimbursement
- Vision insurance
Supplemental pay types:
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment.
- Manufacturing: 5 years (Preferred)
Work Location: In person