Senior Quality Assurance CMC Specialist

Location
Gaithersburg, MD
Posted
Oct 20, 2020
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Your Tasks

Within the Senior QA Specialist – Regulatory Assurance role, you will be responsible to review, compile, analyze and prepare documentation to verify accuracy of process characterization, process validation and Chemistry, Manufacturing and Controls (CMC) documentation in support of Regulatory Affairs’ IND, IMPD, BLA filings.  Among other responsibilities, you will research the manufacturing history of vector products manufactured and provide supporting information to Regulatory Affairs as evidence of testing results, certificates of analysis for vector lots, raw materials, and starting materials. You will review CMC sections of clients' BLA for Quality Assurance to ensure accuracy in comparison with manufacturing records and test results. As a result of your efforts you will support the continued success of Miltenyi Biotec as a whole.

Requirements

  • Bachelor's Degree in Life Sciences and a minimum of 5 five years pharmaceutical or biotechnological experience; or equivalent combination of education and experience
  • 2 or more years of experience preparing documents to support IND, IMPD and CMC regulatory filings and common technical documents required
  • 2-5 years’ experience reviewing and writing technical documentation for biotechnology products required.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures.  Generally, this job is performed in an office environment.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Lentigen Technology, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity