| Job Description: |
Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA.
Position Summary:
Responsible for the development of manufacturing processes for pharmaceutical drug product, technology transfer and phase 3 clinical productions at contract manufacturing organizations. This includes planning and managing the implementation of drug product processes for registration, validation and commercial launch. Leads and develops the Technical Operations drug product technology team, and collaborates effectively with internal and external resources. Provide technical support for drug products at either the commercial or R&D stages. Recommends process improvement projects to internal and/or external partners and follow up on it implementation.
- Leads the development and optimization of robust drug product manufacturing processes for clinical phase 3 and commercial manufacturing
- Develops robust and commercially viable drug product manufacturing processes
- Responsible for successful technology transfers to contract manufacturing organizations
- Responsible for phase 3 clinical drug product supplies
- Supports all technical aspects of commercial drug product manufacturing, including implementation of process improvements, trouble shooting, and technical investigations
- Creates and maintains seamless interaction with other departments including the Manufacturing and Process Development Team, R&D, Quality, Regulatory, and with external partners
- Establishes a culture of open communication and effective collaboration
- Sets high standards for compliance to meet or exceed regulatory agency requirements
- Responsible for technical input for drug product CMC sections of regulatory filings
- Reviews, audits and recommends external partners for drug product process development and manufacturing
- Proactively manages risk, defines impact of risks and develops mitigation plans
- Applies innovative techniques when necessary to solve manufacturing problems Requirements - Bachelor in science / engineering, or equivalent degree and experience
- 10+ years in managerial role in pharmaceutical process development or DP manufacturing at a commercial level
Experience Required:
- Demonstrated leadership in the development of drug product manufacturing processes
- Proven track record in developing and implementing robust and efficient drug product manufacturing processes
- Extensive experience in the development , technology transfer and technical support of sterile drug product manufacturing processes
- Extensive experience in collaborating with sites and third party manufacturers
- Experience in troubleshooting and general support (documentation reviews, deviation investigations, etc.) drug product
- Broad understanding of formulation and drug product technologies, including closure systems (e.g. isolators, etc.)
- Experience with the development of oral dosage forms
- Experience and knowledge on operations of oral dosage equipment such as tablet press (Kikusui, HATA, etc.); fluid bed dryers; high shear mixers; coating machines, etc.
- Experience in validation of manufacturing drug product processes
Desired Competencies and Qualifications:
- MS and/or PhD on engineering, pharmaceutical sciences or related fields is desirable
- Proven track record in cGMP manufacturing
- Proven track record in leading teams with cross-functional scope
- Excellent communication and collaboration skills, ensures alignment with other functions
- Exceptional problem solving skills, fosters excellence throughout the organization
- Broad understanding of regulatory and quality requirements for pharmaceutical products
- Demonstrated ability to see beyond own function to understand business issues and implement best practices
- Ability to leverage an in-depth understanding of the organization to build up credibility and acceptance of projects
- Demonstrated ability to lead and develop teams and individuals
- Extensive experience in overseeing contract manufacturing organizations
- Experience reviewing and/or authoring CMC section for regulatory submissions
- Experience on implementation PAT applications on DP manufacturing (e.g. NIR; Raman)
- Knowledge of cleaning validation regulations
Work Environment:
- Office in Lexington, MA
Physical Demands:
- Up to 30% 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 positions essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Total Rewards:
Our outstanding total rewards package includes: competitive base salary; annual incentive plan with payouts based on results; company-wide performance based equity program; choice of medical plan; dental, life and disability insurance; employee assistance program; flexible spending accounts; 100% vesting in our 401K plan with a competitive company match; employee stock purchase plan; tuition reimbursement; 12 paid holidays, 4 of which are floating; 3 weeks vacation; flexible work schedules; comprehensive reward and recognition program.
We are an Equal Opportunity Employer.
Note to Recruiters:
Relationships with professional recruiters are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors. We are also interested in establishing new relationships with experienced life science recruiters. In order to recruit on Cubists behalf, each recruiting firm needs to have a written contract in place and agree to present candidates directly to Human Resources.
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