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.
I. JOB SUMMARY
Responsible for managing the QC Microbiology Environmental Monitoring (EM) group to ensure the testing and documentation are accomplished efficiently and in compliance with cGMP rules and regulation. The manager will serve in leading the QC EM group with regards to scheduling, design of EM program, and support on EM investigations
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Provide oversight of Quality Control operations focused on the EM program
Provide oversight for training personnel and management of training processes and content.
Represent Quality Control and Emergent during FDA regulatory agency and ISO inspections.
Represent Quality Control and Emergent for customer relation activities.
Provide management coordination of various compliance documentation such as:
o deviations, CAPAs, audits, change controls, validation & technical study protocols and other cGXP compliant documentation.
Provide management coordination of:
o Testing (routine and validation)
Perform Management Review and Approval function for:
o Technical studies and notebook studies, developmental results, method validation protocols (IQ, OQ, PQ) and SOPs
Ensure compliance with the cGMPs regulations and current procedures
Conduct lab audits and participate implementing lab improvement to ensure GMP compliance.
Communicate metrics, trends, and data summaries to senior management as part of Management Review, using a variety of media: intranet, reports, and presentations
Maintain metrics within predetermined limits.
Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements.
Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
Interact with contract, corporate, ISO and governmental agency auditors.
Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to 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 managements assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
B.S. degree in microbiology, Biochemistry, or closely related scientific discipline with at least 5 years of relevant experience or M.S. degree with a minimum of 5 years of relevant experience.
Experience must include 3-5 years of prior supervisory experience in a GMP Quality Assurances or Quality Control laboratory required.
Must have sound knowledge of the functions and expectations of a QC Laboratory in parenteral drug manufacturing and proficiency in Good Manufacturing Practices in an FDA regulated manufacturing facility. Possess skills and general knowledge of QC microbiology methods and environmental monitoring .
Ideal candidate will have laboratory skills that include EM program and testing experience, including EM sampling techniques.
Previous LIMS experience is desired.
Experience in laboratory control including sample accessioning and product testing.
Experience in oversight of QC laboratory investigations including root cause analysis, OOS, and invalid assay investigation.
Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
Must be highly organized, detail oriented and able to manage multiple projects.
Solid communication and presentation skills required.
Must understand cGMPs, CFR, USP, and Aseptic Processing Guidelines
Must have prior experience with regulatory (FDA/USDA) inspections
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.