Associate Director, Analytical Chemistry - San Diego, CA | Biospace
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Associate Director, Analytical Chemistry

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
5/25/2017
Position Type:
Full time
Job Code:
17-034 #804165
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Analytical Chemistry, Chemistry, Pharmaceutical,

Job Description

The Product Development group at Dart NeuroScience is seeking an Associate Director to lead the Analytical Chemistry Group. The position will be responsible for leading all analytical activities in support of Dart small molecule drug substances (NCEs) and drug products and will work closely with internal Process Development and Formulation Development functions and with external contract organizations.

• Lead analytical activities for small molecule APIs/NCEs and drug products according to the FDA and EMA regulatory requirements for investigational products.
• Provide analytical support for internal Process Chemistry and Formulation functions.
• Develop and transfer in-house developed analytical methods to external contract organizations.
• Supervise all analytical activities at the contract organizations.
• Responsibility for an annual outsourcing budget in $1 – 3M range
• Provide input and data for regulatory filings
• Partner with Quality Assurance and Regulatory Affairs to ensure high quality standards are maintained and the proper documentation is completed in a timely manner
• Provide subject matter expertise in analytical support during the manufacturing campaigns for drug substances and drug products.
• Prepare relevant sections of regulatory CMC submissions.
• Lead, mentor and train junior analytical chemistry staff.

Requirements

• Ph.D. in Pharmaceutical Sciences, Chemistry, or related fields with a minimum 10+ years of hands-on experience in performing and leading analytical development activities in the pharmaceutical industry.
• Experience in analytical method development and validation for small molecule drug substances (NCEs) and drug products.
• Thorough understanding of the FDA and EMA regulatory CMC/ICH requirements and established history in preparing IND and NDA regulatory submissions.
• Experience with transfer of analytical methods to and monitor analytical activities at CMOs/contract labs.
• Strong technical, leadership, and project management skills.
• Excellent communication and interpersonal skills.
• May require up to 25% travelling.