Manager, Drug Product - Solid Oral Dosage Job Details

The selected individual will be responsible for supervising the contract manufacturing organizations related to Entereg TM commercial drug product manufacturing in order to meet quality specifications and inventory goals. The main focus of the position will be managing commercial drug product manufacturing but the position will also support early and mid stage development projects as needed and as part of continuing growth.

Duties and Responsibilities:

• Act as a liaison between Cubist and contract manufacturing organizations for the manufacturing of oral dosage drug products.
• Work closely with Cubist Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain groups for the management of manufacturing scheduling, resolution of technical issues and batch record review / release.
• Responsible for the supervision of manufacturing data collection and tracking to monitor trends and drive continuous process improvement.
• Management of technical projects including process validation and support of regulatory filings.

Minimum Basic Qualifications :

• BS degree in biology, biochemistry, chemistry, or chemical engineering.
• 5 years experience in the biotechnology and/or pharmaceutical industry.

Experience Required:

• 3 years experience working in a GMP environment or working with GMP contract manufacturing organizations.

Desired Competencies and Qualifications:

• Well versed in cGMP regulations and possess experience with process validation and project management.
• Experience with oral dosage manufacturing operations.
• Experience with management of contract manufacturing organizations and technology transfer.
• Capable of handling multiple tasks / projects.
• Excellent supervisory, organizational and interpersonal skills.
• Ability to communicate effectively in a diverse team environment.

Work Environment:

• Office environment with some laboratory work.
• Work within manufacturing facilities.
• Travel to contract manufacturing organizations.

Physical Demands:

• Up to 25% travel.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions .

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. We pride ourselves on being a good neighbor and are committed to improving the quality of life of our patients and enhancing the vitality of the communities in which we operate. At Cubist, we believe our core strength is the broad range of individuals who make up our team. The variety of innovative ideas, knowledge, experiences, and cultures our employees bring to their work give us our greatest competitive advantage.

In addition to a culture focused on your professional development and recognition we offer you a flexible work environment and an outstanding total rewards package that is differentiated from the marketplace.

For more information about our culture, opportunities and total rewards program, please visit