Associate Director Analytical Chemistry

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: May 28, 2023

Job Description:

Associate Director Analytical Chemistry page is loaded Associate Director Analytical Chemistry Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-18669 Job DescriptionGeneral Summary:Vertex Pharmaceuticals creates new possibilities in medicine to cure diseases and improve people's lives. The Associate Director, Analytical Chemistry is an exciting opportunity to join Vertex's growing Technical Operations team and contribute to the rapid commercialization of new life-changing products.In addition to be responsible for all aspects of existing commercial projects within areas related to analytical, the Associate Director will play an important role in bringing late-stage product to commercial by partnering with development teams to ensure the robustness of analytical methodology in a commercial QC setting and will take a leadership role in its implementation at contract manufacturing facilities. The Associate Director is expected to lead continuous improvement opportunities throughout method life cycle and have a solid understanding of the regulatory and business impact of making changes to existing analytical technology in order to help define appropriate regulatory and validation strategies to support post-approval changes. The Associate Director will lead high-impact cross-functional initiatives, lead resolution of complex analytical/manufacturing issues, and provide strategic input to the commercialization of new products and maintenance of existing commercial products.To be successful in this role, the candidate must be an excellent collaborator with proven experience in a cGMP pharmaceutical environment while bringing creativity and energy to all teams to promote positive, collaborative, and effective relationships with internal stakeholders and key external suppliers.Key Responsibilities:

• Represents Technical Operations on cross-functional CMC sub teams to influence late-stage product development and minimize commercialization risks while building strong relationships with key stakeholders.
• Owner of commercial analytical methods, specifications and their continual improvement/update.
• Partners with Pharmaceutical Sciences, Supply Chain, Quality and Regulatory on activities to define technical transfer and regulatory strategies which enable process validation, commercial manufacturing, and post approval maintenance of Vertex products at current and new suppliers and manufacturing sites for drug substance.
• Designs/conducts complex troubleshooting activities associated with ongoing commercial manufacturing.
• Reviews/approves commercial analytical documents to ensure its accuracy and high quality of technical and business contents.
• Responsible for analytical sections in regulatory submissions and post approval submissions.
• Acts as a knowledge resource for junior staff within Technical Operations - Analytical team.
• Manage one to three junior full-time staff.Minimum Qualifications:
  • BS/MS and 10+ years or PhD with 6+ years of relevant work experience
  • Proficient in chromatographic method development and validation with a focus on small molecules and drug substance manufacture and controls.
  • Proficient in at least one other area of pharmaceutical development (e.g., impurity control, establishment of specification or physical characterization).
  • Strong knowledge of process chemistry and associated analytical support such as in-process control strategy and methods.
  • Advanced knowledge of cGMP's and associated CMC regulatory considerations in a pharmaceutical setting.
  • Proven record as a strong leader and a committed to be a team player.Preferred Qualifications:
    • PhD in Analytical Chemistry
    • Experience applying QbD concepts, methodology and implementation to analytical technology.
    • Strong knowledge of DoE and statistics
    • Global filing experience
    • Experience with any or all of the following, is a definite plus: process chemistry, forced degradation, compendial methods etc.LI-AS1Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune's Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com -or follow us on Facebook , - Twitter , - LinkedIn , - YouTube -and - Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives. -Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. ALERT: If you have signed up for Job Alerts, please be aware that Job Alert Matches are currently not working. During this time, please check our careers site regularly for all open opportunities. We apologize for this systems issue and hope for it to be resolved soon.

Keywords: Vertex Pharmaceuticals, Boston , Associate Director Analytical Chemistry, Executive , Boston, Massachusetts