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, Analytical, Science and Technology (AS&T) will oversee and manage the activities involved with Technology Transfer and validation of analytical test methods for pharmaceutical and biological drug products as part of the Manufacturing Science & Technology (MS&T) Department supporting the contract manufacturing business unit.
I. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Responsibilities for design, development, execution, statistical analysis of validation protocols for analytical, bioanalytical, and compendial methods
• Oversees and manages the activities involved with transfer of test methods
• Provides technical expertise for method optimization, development, verification, qualification, and validation. This includes analyzing and interpreting data, writing protocols and reports, investigating analytical problems, and developing approaches to rectify those problems
• Provides scientific review and approval of protocols, reports, study design and standard operating procedures
• Performs managerial duties, as assigned in support of AS&T operations such as resource management and failure investigation review
• Oversees introduction of new analytical equipment and technologies
• Leads new product assessments (biosafety, cleaning, viral clearance, etc.)
• Demonstrate strong organizational and technical writing skills
• Support and draft proposal for commercial and government clients
• Act as project lead for client project
• Guide development of transfer protocols and reports
• Requires vaccination against different viruses including Vaccinia virus
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BS degree in Microbiology, Chemistry or Biochemistry or related scientific discipline
Master’s degree or PhD
6-8 years related experience in pharmaceutical, biologics, and/or vaccine development.
• Minimum of 3 years of supervisory experience.
• Minimum of 5 year in an FDA regulated industry.
• Knowledge of CGMP, and Data Integrity
• Must have knowledge of Bioburden testing, Endotoxin testing, Viral and Cell based assays, ELISA, HPLC, FTIR, Osmolality
• Experience in assay method qualification and validations for biotherapeutic and vaccine products
• Experience in assay method investigation
• Training and experience with BSL-2 techniques is a plus
• Knowledge of MS Word, Excel and PowerPoint.
• Must have strong attention to detail and demonstrated decision making ability.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Ability to work individually and in a team environment.
• Excellent written and verbal skills
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.