Manager, Microbiology - United States
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- Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).
- Our company is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies.
- We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs.
- Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, our company family is growing rapidly. Picture yourself at our company and apply today.
- We are currently seeking a highly qualified and motivated scientific leader for the position of Manager Microbiology.
- Directs & coordinates the activities of the laboratory operations
- Develops production and resource plans across different groups that meet production goals in terms of safety, quality, & productivity
- Works with finance groups to construct budgets (revenues, cost basis, staffing levels, investments)
- Manages key performance metrics
- Engages with business development and contract writing personnel to provide key support in project definition and costing
- Develops strategy to grow accounts and expand business relationships
- Effectively develops, leads and trains staff
- Ensures that deliverables are met or expectations are proactively managed towards alternative solutions
- Completes technical definition of projects, generation of testing protocols and procedures, trending of data, generate investigation and deviation reports
- Develops and implements key strategic policies and procedures
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
- Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
- Provides substantial technical support to the groups of the organization
Qualifications for success:
- Bachelor’s degree in Microbiology, Biology with a focus on Microbiology or related Life Sciences Degree
- 5 or more years of experience in the CMO, CDMO or pharmaceutical industry
- 3 or more years of experience directly supervising or managing a staff
- Direct experience or a strong understanding of testing methodologies in 2 or more of the following areas: USP Antimicrobial Effectiveness Testing, Biological Indicators, Microbial Limits, Bacterial Endotoxins Test, Sterility, Antibiotics, Disinfectants and Antiseptics, Water Activity, Environmental Monitoring, Container Closure Integrity Test, Water Testing
- Knowledge of 1 or more of the following: 21CFR, EudraLex – Volume 4, MHRA, Health Canada, PMDA, TGA, KFDA, WHO, etc.
- Proven ability to manage/understand metrics & KPI’s (On-time delivery, 1st time right, Turn-around time, etc.,)
- Previous experience with equipment qualification and computer system validation
- Proficient in MS Office Suite and previous experience working within ERP systems and document repository systems
- Advanced knowledge of safety standards in a GLP or GMP environment
- Proven ability to work within multi-disciplinary teams
- Previous experience working with regulatory agencies such as FDA, EMA, etc., preferred.
- Advanced Excel knowledge
What we offer you:
- In Wilmington, an onsite Learning Center for working parents
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching