|
|
|
|
| Employer Name: |
SpiderID: 2292128 |
| Location: New Haven County, CT, Connecticut |
Date Posted: 6/17/2008 |
| Wage: 115 base |
Category: Biotech |
| Job Code: |
|
| Number Of Openings: 1 |
|
Job Description:
DIRECTOR OF BIOLOGY:
JOB SUMMARY: This position will be responsible for directing a team of scientists in the transfer of researched developed assays to commercialization. In the transfer will be the further development of the assays for either research or FDA cleared/approved applications. After product release provide sustainability of the product by continuous improvements based on customer needs.
ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES
1.Minimum 7 years managing a group of scientist developing and transferring of assays.
a.Ability to set up GMP pilot manufacturer of reagent/assay kits
b.Knowledge of GMP requirements for developing assays
2.Demonstrates strong technical and personnel leadership qualities
a.Can provide technical direction to guide projects to completion
b.Can lead the development team to successful and timely release of product
c.Can develop and build a development organization that can work with research and operations, clinical and sales/marketing
3.Developed assays for FDA clinical studies
4.Worked with outsourced assay developers and manufacturers
a.Developed suppliers of assay components
b.Evaluation of suppliers for capabilities that meet company business and regulatory requirements.
5.Program managed a product to commercialization: planned and execution of the plan to a successful launch
6.Was part of a cross functional team for commercializing a diagnostic product.
7.Provide “on market” support of reagents and assays by providing the necessary continuing science to keep the product current and expectations of customer requirements.
OTHER RESPONSIBILITIES
1.Participate in product improvement and corrective action forms.
2.Develop fiscal budgets for the department
3.Develop timelines of projects reflecting responsibilities and milestones for accomplishing required tasks.
4.Maintaining laboratory safety with discussions at group meeting and insuring training is up to date with members of the lab.
EDUCATION AND EXPERIENCE
PhD educated in the areas of cellular and/or molecular biology, organic or biochemistry
JOB KNOWLEDGE, SKILLS AND ABILITIES
1.Oncology
2.Excellent skills and experience in corporate research and product development
3.GMP requirements for developing pre-production reagents/assays
4.Regulatory requirements for development and clinical studies leading to FDA approvals (PMA) or clearances (510K)
5.Knowledge in molecular and cellular biology science and research
6.Conjugation of fluorescenes with antibodies and probes. (optimum)
7.Fluorescent microscopy
a.Participated in the development of imaging algorithms for segmenting cells (optimum)
8.Flow cytometry (optimum)
9.Cytology methods: tissue and liquid
10.Part of a team that developed instrumentation and reagents for commercialization of a product.
11.Developed control and standards for assays to insure quality control of the assay and its functionality with the instrument.
12.Demonstrated ability to commercialize reagent and assays for successful product launch
SUPERVISORY RESPONSIBILITIES
Minimum of 5 years managing a group either in research, development or commercializing diagnostic assays
TRAINING REQUIREMENTS
1. General Safety
2. Bloodborn pathogens
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Doctoral
Overnight Travel:
Vacation Time:
Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Casual Dress
Contact Information:
| Contact Name: Joseph Anthony |
Company Type: |
| Company: |
|
|
|
| City: Preston |
|
| State: Connecticut |
|
| Zip: |
|
|
|
|
|
|
|
|