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Manufacturing Operations
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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 Solutions and Medical Aesthetics 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 increasingly 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 even-greater certainty and peace of mind.
 
Job Summary:
Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.  Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations.  Responsible for research, development and production manufacturing activities associated with oligos.
 
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. 
  • Independently produces notebook, dev, pilot and production materials per written directions; Analyzes in-process and final oligos using state of the art analytical techniques; Troubleshoots simple manufacturing process problems; Analyzes process data; Creates documents and assists with assembly of change control packages; Maintains labs under cGMP conditions; Completes ERP and cycle count transactions; Keeps accurate records and documentation; Stocks and maintains lab supplies.
Additional responsibilities that apply to Level 2 Chemist position:
  • Provides oligo process support to Operation groups and New Product Development teams
  • Assists in the development of manufacturing processes for transfer to manufacturing
  • Assists with writing development reports, technical reports, development documents and manufacturing documents
  • Executes process validation protocols
  • Participates in transfer, support activities and continuous improvement of existing processes
  • Maintains detailed device history records and training logs.
  • Operates and maintains all general lab equipment and process specific instrumentation (Synthesizers and HPLCs).
  • Installs and validates new instruments and equipment
  • Originates simple change orders for manufacturing docs, SOPs, etc.
  • Trains others on existing and newly developed procedures
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
•           Working knowledge of QSR/GMP.
•           Knowledge of GMP/GLP.
•           Proficiency with MS Word and Excel.
•           Strong math skills.
•           Intermediate EDMS change control skills and ERP knowledge.
•           Knowledge of oligo synthesis, purification, desalting and diafiltration processes.
•           Working knowledge of analytical chemistry specific to oligos. (Maldi MS, HPLC, OD, etc.)Analytical
•           Communication
•           Teamwork
•           Learning
•           Initiative
•           Problem Solving
•           Interpersonal skills
•           Technical skills
 
Education:
Typically requires a Bachelor of Science degree or equivalent.
 
Experience:
Minimum of 2-4 years related experience.
 
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.

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