Associate I, Manufacturing

We're hiring a night shift Associate I, Manufacturing role to support cGMP downstream and upstream manufacturing process for our pharmaceutical manufacturing facility in Baltimore, Maryland.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Associate I, Manufacturing performs and documents cGMP activities to support upstream or downstream production areas and operations. This involves the operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed. This is a full-time, salaried position and is 100% on-site. The schedule is a rotating 7:00PM – 7:00AM schedule (2 days on, 2 days off, 3 days on rotation.)

Catalent’s FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus in Baltimore, Maryland. The campus, featuring two manufacturing facilities, supports Phase 3 through commercial manufacturing of advanced therapeutic products, including Adeno-associated Virus (AAV), and other viral vector-based therapies and vaccines.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record. 

• Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks. 

• Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices. 

• Performs the weighing, dispensing of raw materials for media and buffers 

• Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product. 

• Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc. 

• Dispensing, labeling, transfer/staging of raw materials and parts 

• Assembly/disassembly, cleaning and sterilization of components, parts and equipment 

• Maintaining equipment, area and cleaning logbooks 

• Cleaning sanitizing production rooms and equipment 

• Stocking production and cleaning supplies 

• Other duties as assigned

The Candidate

• Bachelor’s Degree from an accredited college or university, with an emphasis in a scientific or engineering discipline, and relevant work experience.  

• Associate’s degree, in a scientific, engineering or biotechnology discipline, with a minimum of 1-year related work experience; coursework with biotechnology focus highly desirable.

• High School Diploma with a minimum of 2 years’ cGMP manufacturing experience.

• Basic knowledge of current Good Manufacturing Practices (cGMP’s), in addition to biopharmaceutical manufacturing operations.

• Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups). 

• Able to fluently communicate in English and exhibits excellent written and oral communication skills. 

• Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management. 

The anticipated salary range for this position in Maryland is $58,240 - $80,080 plus shift differential and annual bonus, when eligible.  The final salary offered to a successful candidate may vary, a