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 Manager position has a critical role on the Analytical Chemistry testing team supporting various stability programs, release testing, and leading and managing 2-6 individuals. This unique position requires extensive knowledge of GMP compliance, ICH guidelines and CFR regulations which govern our laboratory processes. The individual is responsible for overseeing the quality control and other lab managerial duties in support of laboratory testing activities in a highly regulated laboratory environment. The main responsibilities include management of laboratory quality systems, including oversight of data review, equipment and materials, samples and reagents, and documentation.
The Manager will lead a group of enthusiastic scientists and provide scientific expertise and leadership for various activities in the Analytical Chemistry team. Must be able to multi-task, adapt, and be flexible in a fast-paced work environment. GMP-compliant documentation, organization, and accountability are key to this position.
The Manager will be responsible for providing strategy, planning, and execution of assays to support CMC manufacturing activities including release and stability testing of early to late phase vaccine products, raw material testing, and oversight of Environmental Monitoring. Manager will work closely and interact with other functions such as Analytical Development, Product & Process Development, Project Management, and Quality Assurance groups to ensure timely delivery of stability data, provide project updates, as well as scientific direction and oversight to ensure that project and team needs are met.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Lead a team , train staff, coach, determine responsibilities, and actively manage performance and individual development of direct reports.
• Manage and coordinate day-to-day analytical activities of team.
• Performs reviews of laboratory data and documentation with emphasis on good manufacturing processes (GMP) and good documentation practice (GDP).
• Manages, supports, and monitors equipment maintenance, calibration, and qualification
• Supervises research scientists and associates engaged in stability and release testing.
• Writes and reviews SOPs, worksheets, and checklists related to QC compliance.
• Proactively assess capabilities and processes, takes initiative in promoting best practices, identifying gaps in operation, drives for continuous improvements of processes and procedures, and implements process efficiency tools (e.g., Smartsheet, ELN).
• Works collaboratively with cross-functional teams to proactively communicate analytical outcomes that may impact other areas and solicits input from partners to drive analytical activities to timely and quality finish in support of overall project timelines.
• Prepares and reviews standard operating procedures, method development reports, qualification/validation protocols and reports, presentations, change control documents, deviation, and investigation reports.
• Critically reviews data, thoroughly analyzes results and methods, solves analytical problems, troubleshoot assays, provides timely feedback to secure prompt resolution of technical and quality findings, and meets regulatory expectations for analytics.
• Oversight of the Quality Systems including but not limited to Deviation, CAPA, , Training, Change Control.
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
• PhD in a scientific discipline with minimum of 4 years experience or
• MS with 6 years experience in a research environment or
• BS with 8 years of relevant experience in a research environment with demonstrated scientific skill sets
• A strong team leader and experience in building teams.
• Excellent interpersonal skills, proven ability to work effectively with cross-functional stakeholders.
• Productive, willing to take initiative, able to work in a collaborative team
• Exceptional organizational and project management skills with the ability to multi-task and prioritize workload to deliver complex objectives under timelines.
• Excellent verbal and written communication skills with proven ability to build open and collaborative work environment.
• GMP experience in a CMC group (QC/Analytical Development) in analytical method development and validation under ICH/FDA guidelines is required.
• Experience with Good Documentation Practice (GDP)
• Expertise in developing cell-based potency assays to reflect mechanism of action of vaccine candidates and relative potency determination, with good understanding of the required statistical methods.
• Experience in viral infectivity assays such as plaque or immune-plaque assays, or TCID50, etc.
• Working knowledge of regulatory and industry guidelines for Chemistry Manufacturing and Controls (CMC).
• Extensive knowledge and hands-on experience in a broad array of biochemical/biophysical techniques, with product characterization, drug substance and drug product analytical techniques (e.g., cell-based bioassays, ELISA, Western blot, CE, SDS-PAGE, RP-HPLC, SEC-HPLC, AEX-HPLC).
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
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.