Position Summary: The individual will assist in the development of immunoassays and be responsible for performing the necessary experimentation and tasks to enter a project/product into Design Control. The individual will perform and/or support study phases from Discovery to Design Verification, Validation, Transfer and Release.
Essential Job Functions:- Performs a major role in the generation and transfer of project/product information for the initiation of Design Control projects.
- Establishes Manufacturing processes and Quality Control (QC) procedures for new products.
- Performs the necessary Design Verification studies to support new product launches.
- Performs and/or supports Design Validation studies to support new product launches.
- Performs a major role in the scale-up of new manufacturing processes as needed.
- Assists in the transfer of new technologies, products and/or manufacturing processes into and out of the company.
- Assists in the training of Manufacturing operators, QC technicians, and Quality Assurance (QA) personnel in specific areas of expertise.
- With the assistance of a supervisor, designs experiments to support Discovery, Robustness, Feasibility and Verification studies for new products.
- Interprets results and summarizes data into project reports.
- Performs activities in a GMP/GLP environment.
- Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner.
- Performs other duties as assigned.
Job Specifications (skills, knowledge, special training, certification, license requirements):- Immunoassay development and manufacturing experience
- Technical problem-solving skills and discipline
- Ability to write clear, concise technical reports
- Analytical and preparatory chromatography experience
- Experience with automated immunoassay analyzers
- Protein modification/chemistry knowledge desirable
- Quality control experience desirable
- Excellent verbal and written communication skills
- Must be detail-oriented and thorough
- Ability to work with various software packages
- Ability to make presentations to various groups of individuals
- Ability to work with potentially hazardous materials
- Manual dexterity and ability to do visual inspections
- Ability to travel nationally and internationally
Education and Work Experience Required:- Associates Degree or equivalent required; B.A./B.S. in Science/Engineering preferred
- Minimum of 3-5 years of laboratory experience, preferably in the diagnostic or pharmaceutical industries preferred
The base salary range for this position is $76,000- $88,000/year. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. The typical work schedule for this position is Monday to Thursday with half-day Fridays.
We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement.
We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.
