Operations Scientist Jobs

Job Summary

The Scientist position will assume an individual contributor role focused on supporting New Product Introduction to meet company pipeline objectives. The candidate will participate on NPI core teams, ensuring transfer of technically and statistically sound methods and sustainable manufacturing processes. The candidate will coordinate transfer activities across operations working with Quality and Process Transfer groups 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.

• Generates clear and concise NCE/CAPA Investigations
• Devises and recommends methods to resolve technical problems.
• Excellent understanding of FDA cGMP
• Good understanding of design control.
• Plans and executes own experimental work and may oversee others to accomplish project goals.
• Provides SME support on internal audits.
• Responsible for initiating, leading and executing technical work to resolve technical problems across multiple functions.
• Supports regulatory affairs with technical submissions.
• Contributes to the development of novel technical methods.
• Generates statistically based test plans.
• Consistently collaborates and communicates effectively outside the department
• Core team rep with minor mentoring by senior staff
• Prepares and executes protocols and reports.

Qualifications

Education

• BS and 6 years related experience or MS and 4 years or PhD and 0-2 years related experience in a scientific discipline or equivalent in engineering

Experience And Skills

• Understanding of scientific method, experimental design and statistical analysis
• Solid knowledge of molecular biology, biochemistry, chemistry or related disciplines
• Good understanding of Hologic technology and nucleic acid amplification
• Sound technical writing
• Ability to work in and/or lead small teams
• Ability to design both standard and factorial experiments appropriate for assay development
• Experience working in a timeline driven setting
• Ability to analyze data and come to valid scientific conclusions
• Ability to present data to medium to large groups both internally and externally
• Knowledge of cGMP expectations for laboratory records and quality systems.
• Good understanding of Analytical Method Development including HPLC and mass spectroscopy.
• Ability to troubleshoot and solve technical issues

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• Exposure to blood.
• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/moving and carrying products weighing up to 40 pounds.

Additional Information:

The annualized base salary range for this role is $91,900 to $143,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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.