Hologic Methods Development Scientist 3 in San Diego, California
Methods Development Scientist 3
Post Date Jan 04, 2019
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
The Methods Development Scientist-Scientist 3 position will assume a leadership role focused on Analytical Method Development and Validation to meet company pipeline objectives. The candidate will assure timely, appropriate method development, validation and implementation to meet project deadlines. The candidate will work with Quality group to ensure that high quality standards are maintained and appropriate documentation is completed.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Responsible for developing robust analytical methods prior to analytical method transfer to QC
Provide technical and trouble-shooting support for analytical instrumentation and all analytical development activities.
Trouble-shoot, calibrate, validate and maintain instruments for HPLC, and mass spectrometric methods.
Keep up with new developments in analytical methods and make recommendations for implementation of new measurement methods and instrumentation
Identify, execute, and support process improvement initiatives to increase efficiency
Oversees the resolution of product and process issues to ensure on-market product availability
Generates and presents proposals for product specification changes.
Understands and is able to effectively put into practice the principles of root cause analysis and scientific method.
Applies and interprets product and process risk analyses.
Able to work independently and requires minimal guidance to perform required tasks
Work with peers and/or subordinates to ensure timely completion of projects and tasks
Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites
Provide leadership to junior staff
Education and Experience
- BS in Chemistry or Biochemistry with 6-8 years or MS with 4 to 6 years of relevant experience
Understanding of cGMP/GLP, USP, FDA and ICH guidelines
Working knowledge of analytical techniques and instrumentation
Must possess chemistry knowledge and technical skills in operating and troubleshooting analytical equipment including HPLC, FTIR, Mass Spectrometry and UV/VIS Spectrophotometer.
Experience evaluating analytical data and drawing meaningful conclusions
Leadership and project management skills
Strong attention to detail, excellent written and oral communication skills
Experience working in a timeline driven setting
Ability to work with a team of individuals to meet goals
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans