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Staff Scientist, Drug Product Development (320-419)

ARIAD Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 5/1/2013 Position Type: Full time Job Code: 320 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Drug Safety

Description



Plan and execute activities for developing commercializable formulations and processes for new products. Manage product development activities at contract manufacturers (CMO) to support global clinical studies and commercialization. Work collaboratively with partners, CMOs, suppliers, and internal teams to ensure product development timelines are met. Communicate changes to the plan to all parties to ensure everyone is working towards the same revised goal/plan.


Duties and Responsibilities

- Develop globally acceptable formulations and manufacturing processes for new drug candidates
- Direct drug product development, process development and technology transfer activities with CMOs
- Analyze and translate data into actionable recommendations to improve the process
- Provide scientific and technical leadership for formulation development projects
- Represent department at CMC/Project Team meetings and work closely with other departments to meet project timelines and objectives
- Apply current CMC regulatory requirements and guidances to support global registration of new products
- Write and review development reports, provide CMC documentation for regulatory filings
- Develop, communicate and implement contingency plans for unplanned events
- Other duties and responsibilities as required
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements



- B.S. or M.S in pharmaceutical sciences or chemical engineering with 8+ years of relevant experience.
-  Ph.D. in pharmaceutical sciences or chemical engineering with 4+ years of relevant experience
- Demonstrated scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents
- In-depth understanding of pharmaceutical formulation principles and basic unit operations
- Hands-on experience and demonstrated competence working with lab equipment
- Demonstrated evidence of analytical, planning and execution capability
- Experience with solid dosage, highly potent compounds (oncology experience a plus)
- Ability to work in a fast-paced environment
- Experience with QbD and experimental designs a plus
- Strong oral and written communication skills and interpersonal skills
- Experience with GMP requirements is a plus
- Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project etc.)
- Strong commitment to business ethics
- Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
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