Principal Engineer, Manufacturing Tech Support

Description ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a commercially available novel therapy, ERBITUX� (cetuximab), as well as a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders.

GENERAL SUMMARY

This position is responsible for implementing the process validation program for the manufacture of both new and existing biologicals. Responsibilities include planning, writing and managing the execution of process validation protocols, such as consistency and product comparability protocols. The authoring of manufacturing and validation sections of regulatory filings will be required. This position will report to a Sr. Director or Director in Manufacturing Technology and will interact with Engineering, Manufacturing, Validation, Quality Assurance, Quality Control and Regulatory Departments. Interaction may be required with contract producers of ImClone�s products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is essential.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.

Responsible for supporting manufacturing operations through the performance of the following duties:

1.Plan and manage the execution of process validation studies, such as process consistency studies, performed for ImClone�s products.

The main areas of focus are purification and downstream processing activities. Author the required protocols, reports and regulatory documentation associated with the executed studies.

2.Review and approve protocols and reports authored by other groups.

3.Author relevant portions of drug substance manufacturing and process validation sections of regulatory filings.

4.Author technical reports supporting technology transfers, deviation/adverse event reporting and process analyses/trending. This responsibility is shared with the Process Sciences Group.

5.Support the Manufacturing Process Sciences Group, the Statistics and Quantitative Sciences Group and the Clinical Manufacturing Group as required.

6.Consult with other groups to troubleshoot manufacturing process problems.

7.Ensures cGMP compliance.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE

1.BS degree in Chemical Engineering (equivalent non-engineering title for Biochemistry, Chemistry, Microbiology degrees).

2.Minimum of 12 years experience in a GMP production/development environment.

3.Has previously started-up and/or had a management role in a biotechnology facility.

4.Has detailed process and equipment knowledge of protein purification processes and functions. Similar knowledge of cell culture processes a plus.

5.Process validation experience required.

6.Has a thorough understanding of cGMP requirements for a large scale manufacturing facility.

7.Experience in successful facility licensure a plus.

8.Excellent communication skills, both oral and written.

9.Demonstrated supervisory skills.

Requirements Please refer to the Job Description for the qualifications.