Senior Manager, or Associate Director, Biologics Outsourcing

Date Posted:

1/12/2012

 

Job ID:

1742

 

Company:

Company combines their own cancer biology program with drug research development and commercial proficiency in its attempt to discover and develop targeted cancer therapeutics. Driven by our dedication to revolutionary science, our passion for drug research and development and craving to optimistically impact patients’ lives, We are moving swiftly to transport momentous new treatments to the medical oncology community and their patients.

 

Location:

Cambridge

 

Reports To:

Director Manufacturing

 

Salary:

compensatory with exp.

 

Education:

MS in chemistry, biology, chemical engineering or equivalent.

 

Requirements:

The ideal candidate has significant experience developing recombinant mammalian cell culture processes for manufacture, and scaling cell culture and standard downstream purification techniques to produce biopharmaceuticals in-house and at contract manufacturing organizations. Additional responsibilities will include contributing significantly to the design and creation manufacturing infrastructure, such as operating procedures, technology transfer systems, and data bases. 5 years experience supporting the manufacturing of drug substances derived from mammalian cell culture and purified by chromatography and membrane technologies. 3 years contract manufacturing experience and relationship management. Applied process development and process optimization skills. Familiarity with FMEA, DOE, process characterization methods. Strong analytical and molecular characterization knowledge and experience. Superior written and verbal communication skills and presentation skills. Experience managing process data and analysis to support process design. Excellent document preparation and review skills. US and EU facility and process validation and compliance expertise . Knowledge of contracting business systems and agreements. Ability to travel 20% of time.

 

Duties:

Overview: Reporting to the Director of Manufacturing, this position will oversee process development, tech transfer, clinical manufacturing and process validation of monoclonal antibody drug substances at contract manufacturers. The incumbent will evaluate the process and direct development activities focused on process comparability, process optimization, commercial viability and regulatory compliance.