MSAT Associate Director (Investigations and Strategic Projects Lead)
MSAT Associate Director (Investigations and Strategic Projects Lead)
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Job Description
Job Description
General Summary:
The Associate Director MSAT (Investigations and Strategic Projects) is responsible for leading complex technical investigations driving strategic process improvements and fostering a culture of continuous improvement within manufacturing operations. This role will leverage Six Sigma methodologies including DMAIC and lead complex technical investigations utilizing statistical methods and multivariate analysis to understand and identify contributing factors influencing manufacturing outcomes. In addition this position will drive strategic improvement initiatives across manufacturing operations as a form of continuous improvement. The incumbent will collaborate cross-functionally with Quality Engineering Manufacturing Process Development and Regulatory teams to ensure robust root cause analysis (RCA) effective corrective and preventive actions (CAPAs) and sustainable process improvements are deployed that align with business and regulatory expectations.
Key Duties and Responsibilities:
Lead and manage high-impact technical investigations applying structured problem-solving methodologies such as DMAIC to ensure thorough root cause analysis and CAPA implementation.
Act as a subject matter expert (SME) in major investigations related to deviations out-of-specifications (OOS) or out-of trends (OOT) and process failures ensuring alignment with regulatory expectations.
Utilize a data-driven approach to investigations leveraging statistical analysis and multivariate data analysis to identify root cause systemic issues and identify options to prevent recurrence.
Develop and present investigation reports to senior leadership and regulatory agencies as needed.
Lead strategic improvement projects focused on improving process control process efficiency and manufacturing robustness using DMAIC principles.
Identify prioritize and execute initiatives that reduce variability increase yield and enhance compliance through data-driven decision-making.
Collaborate with cross-functional teams to implement innovative solutions integrating Lean and Six Sigma methodologies to drive sustainable improvements.
Management of a team MSAT scientists and engineers supporting major investigations and strategic projects
Knowledge and Skills:
- Previous experience working in a highly matrixed environment.
- Extensive experience with biologics process development and cGMP manufacturing.
- Experience with cGMP regulations/guidance and regulatory agency inspections.
- Experience authoring/reviewing CMC product submissions and post-approval changes.
- Experience with continuous improvement proficiency with operational excellence preferred.
- Experience working with external manufacturing partners (CDMOs) suppliers and service providers.
- Ability to travel nationally and internationally up to 10%.
- Flexibility to work on site a minimum of 3 days per week.
Education and Experience:
Bachelors Masters or Ph.D. in Engineering Biotechnology Biochemistry or a related scientific field.
6-8 years of experience in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment with a focus on MSAT process investigations and improvement initiatives.
Strong expertise in Six Sigma methodologies including DMAIC; Lean Six Sigma Yellow Belt/ Green Belt preferred.
Demonstrated experience leading major investigations and implementing effective CAPAs in a regulated environment.
Proficiency in statistical tools (JMP Statistica etc.) and data-driven decision-making to drive process optimization.
Proven ability to lead cross-functional teams and manage multiple high-impact projects simultaneously.
Strong communication and presentation skills with experience delivering technical reports and presentations to senior leadership and regulatory bodies.
Experience working with external manufacturing partners (CDMOs) suppliers and service providers.
Preferred Qualifications:
Lean Six Sigma Yellow belt Green Belt or Black Belt certification.
Experience with technology transfer scale-up and process validation activities.
Experienced with advanced analytics and digital tools.
Pay Range:
$165200 - $247700Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:
In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
Company 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 persons 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.
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
Required Experience:
Director
Employment Type
Full-Time
