Senior Manufacturing Associate

Auxilium Pharmaceuticals is seeking a Senior Manufacturing Associate for it's Horsham facility.  This position is responsible for performing all necessary production support activities for the development and cGMP manufacture of protein products.  Work in a hands-on capacity to support both the fermentation and purification GMP production areas.

 

The Major Responsibilities are:

 

1.       Perform and coordinate daily production support activities for the manufacture and validation of biopharmaceutical products.  Responsible for inventory, preparation and storage of equipment related to GMP production.

2.       Assemble, clean and sterilize production equipment using autoclaves, CIP, SIP and/or glassware-washer technologies. 

3.       As required, dispense raw materials for GMP manufacturing operations

4.       Prepare media and buffers for fermentation and purification production steps per daily manufacturing schedules.

5.       Document work as per approved forms, SOPs, and batch records.

6.       As required, troubleshoot and assist with PM and validation of process equipment

7.       Assist with cleaning validation activities as required (operate equipment, take samples, submit samples, etc.)

8.       Create/revise/review/approve SOPs and forms applicable to manufacturing support.  Trend production data associated with buffer/media preparation.

9.       In consultation with plant management, resolve manufacturing deviations/non-conformances applicable to manufacturing support areas.  As necessary, review completed documentation used in manufacturing support functions and assist in the correction and resolution of errors and discrepancies prior to quality review.

10.   Verify the completion of daily facility monitoring activities required for on-going operations.

11.   Maintain individual training records

12.   Ensure manufacturing support operations are established and maintained in compliance with all applicable regulations, guidelines and safety polices and procedures.

13.   Train the junior members of the Mfg support group on SOPs as required.

14. Organize the daily manufacturing support schedule of activities based on input from management and the USP/DSP groups.



The required Training and Experience:

§         Minimum 2-4 years working in biopharmaceutical cGMP manufacturing environment.

§         Experience with CIP, SIP, autoclaves, fermenters, pressure-rated vessels, integrity testers

§         Experience with preparation of media and buffer solutions under cGMP.

§         Working knowledge of cGMP and equipment cleaning and sterilization practices for biopharmaceutical products.

§         Experience working with or in commercial and/or clinical manufacturing groups

Auxilium offers competitive salaries, an outstanding benefits package that includes health and welfare plans, 401(k) with match, flexible spending accounts, employee stock purchase plan, and wellness programs, and a professional and dynamic work environment.

Qualified applicants can apply via:  https://home.eease.com/recruit/?id=42647