Manufacturing Representative

Description:

As a Manufacturing Representative, you will check and schedule resources to ensure on-time delivery. Your scientific knowledge and background will be leveraged through your review of formulation documents and active ingredient dilution to ensure that products are manufactured to specification.

You will have an opportunity to become skilled in the use of a wide range of lab instruments, including but not limited to spectrophotometers, conductivity meters and auto-pipettors, all of which are essential to meeting our customers' requirements. Having the ability to learn quickly on the job, anticipate and resolve potential manufacturing and delivery issues and maintaining the highest level of quality are critical. Additionally, you will work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. You will also exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Key responsibilities include:
 

• The manufacturing of oligonucleotide APIs in a GMP environment.
• Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes delivered from Manufacturing Technical Services into Manufacturing.
• Write and revise standard operating procedures according to regulatory and procedural guidelines.
• Work with Validation and Engineering personnel to validate new equipment and facilities.
• Work with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control, etc.).
• Maintain, calibrate, and trouble shoot critical process equipment.
   

Shift Details:

The schedule will be Day shift (4:30am - 5:00pm) or Night shift (4:30pm – 5:00am) working a Pitman schedule: of 2 days working, 2 days off, 3 days working, 2 days off, 2 days working, then 3 days off.

Qualifications
 

• Bachelor of Science Degree in related field or equivalent combination of education/experience
• 1+ years of related manufacturing experience, pharmaceutical manufacturing environment preferred
• Previous knowledge of oligonucleotide synthesis, HPLC, UF, conjugation, and lyophilization is advantageous
• Detail-oriented and can perform technical duties following standard operating procedures and general laboratory safety rules
• Clean room environment experience desired
• Experience working in a FDA regulated manufacturing environment highly desired