Manager, Microbiology - United States
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Posted on : 12 June 2017
- 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.
The Manager of Microbiology will manage and coordinate the activities of our Microbiology group that offers services to the pharmaceutical and biotechnology industries. The Manager, Microbiology is responsible for developing production and resource plans to meet goals in terms of safety, quality, output and costs. The Manager will ensure proper staff training and conduct key required training while ensuring that deliverable's are met or expectations are proactively managed toward alternative solutions.
As the Manager, Microbiology, you will:
- 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