Vertex Pharmaceuticals Inc. is looking for a dynamic and visionary leader to support the Development Bioanalytical Team in Cambridge, MA. The Director of Development Bioanalytical group reports to the Vice President of Drug Metabolism and Pharmacokinetics and is responsible for directing and managing activities related to GxP bioanalytical support and assay development for Vertex's drugs that are in early and late stage development. As a senior level Scientific Director, the employee is expected to recognize the importance of and participate in creating a culture of process improvement with a focus on applying highest standards of GxP compliance, streamlining our processes, adding value to our business and meeting business needs. The individual is expected to develop a short-term plan and long-term strategy, and to integrate these with the objectives of the other departments in Vertex. He/She will establish requirements and provide oversight for development and validation of bioanalytical methods for the quantitative analysis of small molecule drugs and metabolites, in plasma and other biological matrices in support of nonclinical and clinical studies. In addition the individual will have the following responsibilities:
- Manage and direct a team of technical and scientific staff.
- Ensure the highest standards of GxP compliance are maintained in the workplace and operate under established corporate standards for new process development.
- Provide mentoring and guidance to the staff.
- Perform technical assessments of Contract Research Organizations (CROs) and oversee the outsourcing of method development and transfer of bioanalytical methods to CROs.
- Interpret and provide bioanalytical results to DMPK, Clinical Pharmacology, Drug Safety Evaluation and other scientists and project teams.
- Timely reporting of data in various formats, including GLP-compliant validation and bioanalytical reports.
- Keep abreast of ongoing regulatory updates and ensuring the lab SOPs and quality standards are updated to maintain compliance with such standards.
- Enhance the department productivity by assessing and adopting appropriate assay methods, automation, and industry/regulatory guidelines for assay technologies.
- Assure training for full compliance with GxP regulations for laboratories, personnel and systems where appropriate.
- Preparation, review and approval of SOPs
- Review and contribute to regulatory filings.
Education and Experience
Ph.D. in chemistry, biochemistry, or pharmaceutical sciences with 10 + years of experience in GxP-compliant bioanalytical assays in a pharmaceutical or biotechnology company or comparable organization, and at least 5 years of management experience.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, and most recently was named the top employer in Science magazine's 2011 annual survey. For more information and to view Vertex's press releases, please visit www.vrtx.com.
- Expertise in disciplines of analytical chemistry, biochemistry, molecular biology, immunology, protein chemistry and biology.
- Strong technical skills and hands-on experience with HPLC, LC-MS/MS and related technology platforms.
- Thorough knowledge of GxP regulations, ICH guidance documents and industry standards for bioanalytical methods.
- Knowledge and understanding of pharmaceutical development, quality control and validation.
- Extensive drug development experience.
- Ability to prioritize and successfully manage complex and competing projects.
- Excellent communication and organizational skills, both written and verbal.
- Experience and ability to build strong working relationships with analytical CROs and ability to interface with collaboration partners to resolve issues rapidly.
- PK data analysis and interpretation from animal studies
- Extensive knowledge of drug metabolism, pharmacokinetic and pharmacodynamic principles, PK analysis.
- Have working knowledge of WinNonLin and other PK modeling software
- Ability to proactively mitigate quality/regulatory risks.
- Must have the leadership skills to drive change, high energy level and strong organizational management skills.
- Ability to work successfully with inter-disciplinary teams environment.
- Ability to manage resources, budget and schedules to ensure completion of tasks and delivery of data and reports on time.
- Embody the Vertex Core Values of Uncompromising Commitment to Patients, Fearless Pursuit of Excellence, Innovation is Our Lifeblood and We Wins
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law.
Vertex Pharmaceuticals aims to cure patients with previously incurable diseases. The biotechnology company uses an integrated,...