Valeant Pharmaceuticals

Senior Principal Scientist (Team Leader)

US-CA-Petaluma
Job ID
8597
Pos. Category
R&D
Pos. Type
Full Time

Overview


Serves as a primary technical advisor in Analytical Sciences for analysis of pharmaceutical active ingredients, excipients, and topical drug products. Enhances the company’s capability in analytical method development/validation and trains others. Organic chemistry working knowledge to recognize potential degradation pathways, drug-excipient interactions, and structure elucidation of unknown degradation products / impurities to support pharmaceutical development is desirable. Experience in applying ICH guidelines to ANDA and NDA submissions for dermal drug products is a plus. Has good communication skills, is well organized and adept in identifying key project steps and corresponding timelines/deliverables. Monitors the scientific and financial progress of assigned projects. Prepares protocols and technical reports. Ensures that laboratory work under the job candidate’s direction is scientifically sound and meets project objectives. Experienced in GMP and GLP, working with regulatory agencies for successful NDA and ANDA submissions.
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Responsibilities

 

• Serves as primary technical consultant / advisor for other scientists and management
• Directs laboratory work and ensures deliverables
• Prepares technical proposals and project budgets
• Provides project leadership including technical progress and financial review
• Serves as consultant / advisor to other scientists and management
• Prepares technical reports
• Trains individuals and develops training programs
• Supervises laboratory staff
• Conducts laboratory investigations for anomalous results in a compliant and thorough manner

 

Primary Functions:

• Serves as a highly technical pharmaceutical analysis expert
• Directs physical, wet chemical and instrumental analysis, including HPLC and GC
• Develops technical proposals and estimates project costs
• Keeps current in new analytical capabilities and advises management on industry trends and business opportunities
• Provides an expert interpretation of laboratory results and designs experiments
• Prepares analytical reports and documentation for regulatory filings
• Effectively communicates with managers on project status and problems encountered
• Provides training, supervision and scheduling assistance for Technicians and Chemists
• Develops training programs
• May lead laboratory safety programs
• Contribute to patents and the scientific literature

Qualifications

• Pharmaceutical analysis expert with advanced training

• Good working knowledge of the pharmaceutical industry and regulatory requirements (open to new graduates MS or PhD with strong knowledge of interactions and reactions between molecules)
• Ability to exercise independent intellectual judgement based on the individual’s specialized skills in pharmaceutical analysis
• Demonstrated program management skills
• Good laboratory technique and able to train others
• Advanced troubleshooting and method development skills
• Technical project leadership abilities
• Safety minded in performance of duties
• Quality minded with ability to perform work with accuracy and in accordance with established procedures
• Effectively communicates with Manager, team members, and Senior Management
• Organized and able to perform duties in a timely manner
• Analytical
• Innovative

 

**Senior title will be based on level of experience, candidate can be brought in at the scientist level

**Recent PhD Graduates with organic/analytical expertise welcome to apply

 

Required Education/Experience/Training:

  • Minimum: Bachelor’s or Master’s degree in chemistry or related scientific field with approximately fifteen years experience in a pharmaceutical analysis
  • Preferred: PhD degree in chemistry or related scientific field with ten years experience in pharmaceutical analysis

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