External Manufacturing Associate Director, Drug Product Small Molecule
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Job Description
General Summary
The External Manufacturing Associate Director role is a key member of Vertex's External Manufacturing Organization (ExM), providing support, strategic insights and enterprise thinking to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO). This leader will cultivate and leverage multiple cross‑functional business relationships to identify and execute creative solutions to organizational opportunities and challenges. This role will be responsible for managing a subset of the Small Molecule Drug Product external network of Contract Manufacturing Organizations (CMOs).
Key Duties and Responsibilities
In partnership with Supply Chain, MSAT, Quality and Finance, develop external manufacturing production plans and drive plans to execution (on time in full) to ensure a robust supply chain
Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on‑time shipments, quality compliance and cost management) – be Vertex's eyes and ears at the CDMO for flawless execution of commercial operations
Optimize tools and streamline processes ExM phases which are employed to support the Operations Model
Define and build‑out dashboard reporting, measuring additional business/supplier KPIs and metrics
Partner with Analytics & Insights, digital strategy teams and DTE, to build data connections to supplier data
Define standardized governance processes
Partners with EXM phase leads in identifying & implementing strategies to enhance efficiency, reduce costs, and drive initiatives for continuous improvement across our external manufacturing network
Partners with leadership and Supply Chain, MSAT, Finance, and Strategic Sourcing organizations to develop a strategic long‑term manufacturing network strategy to maintain a flexible, reliable, robust, efficient and cost‑effective manufacturing network
Support the EXM organization in identifying internal process improvements opportunities, reducing waste and creating efficiencies
Knowledge and Skills
Demonstrated experience in biotech or pharmaceutical industries, in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology industry.
Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
Strong technical background in drug product (small molecule, oral solid dose preferred) manufacturing operations.
Solid project management skills and experience managing complex projects.
Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
Strong leadership and an innate ability to collaborate and build relationships is critical.
Ability to work calmly and make sound decisions in a fast‑moving environment of uncertainty and change
Flexibility to work shift hours required to cover critical process steps
Ability to travel, national and international, up to 30%
Education and Experience
Bachelor's degree in Chemical Engineering, Chemistry or related discipline
8 years progressive experience in a management/leadership role in the biotechnology/ pharmaceutical industry with a focus on external manufacturing and commercial operations
Proven ability to support the management of complex budgets, strategic planning and provide analysis of diverse information in a fast‑paced environment
Excellent communication and interpersonal skills, with the ability to influence cross‑functional stakeholders and present insights to all levels of senior stakeholders
Demonstrated continuous improvement mindset, driving efficiencies, process improvements across diverse initiatives
Strategic thinker with strong results‑orientation and sense of urgency to deliver quality results on time and in a highly ethical and professional manner
A problem solver with a hands‑on approach, possessing business acumen and the ability to anticipate business and organizational needs
Resilient and able to work well in an ambiguous, demanding, fast paced entrepreneurial environment
Pay Range $160,000 - $240,000
Disclosure 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 Eligible
Flex 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 Vertex's 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 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.
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.
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Key Duties and Responsibilities
In partnership with Supply Chain, MSAT, Quality and Finance, develop external manufacturing production plans and drive plans to execution (on time in full) to ensure a robust supply chain
Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on‑time shipments, quality compliance and cost management) – be Vertex's eyes and ears at the CDMO for flawless execution of commercial operations
Optimize tools and streamline processes ExM phases which are employed to support the Operations Model
Define and build‑out dashboard reporting, measuring additional business/supplier KPIs and metrics
Partner with Analytics & Insights, digital strategy teams and DTE, to build data connections to supplier data
Define standardized governance processes
Partners with EXM phase leads in identifying & implementing strategies to enhance efficiency, reduce costs, and drive initiatives for continuous improvement across our external manufacturing network
Partners with leadership and Supply Chain, MSAT, Finance, and Strategic Sourcing organizations to develop a strategic long‑term manufacturing network strategy to maintain a flexible, reliable, robust, efficient and cost‑effective manufacturing network
Support the EXM organization in identifying internal process improvements opportunities, reducing waste and creating efficiencies
Knowledge and Skills
Demonstrated experience in biotech or pharmaceutical industries, in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology industry.
Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
Strong technical background in drug product (small molecule, oral solid dose preferred) manufacturing operations.
Solid project management skills and experience managing complex projects.
Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
Strong leadership and an innate ability to collaborate and build relationships is critical.
Ability to work calmly and make sound decisions in a fast‑moving environment of uncertainty and change
Flexibility to work shift hours required to cover critical process steps
Ability to travel, national and international, up to 30%
Education and Experience
Bachelor's degree in Chemical Engineering, Chemistry or related discipline
8 years progressive experience in a management/leadership role in the biotechnology/ pharmaceutical industry with a focus on external manufacturing and commercial operations
Proven ability to support the management of complex budgets, strategic planning and provide analysis of diverse information in a fast‑paced environment
Excellent communication and interpersonal skills, with the ability to influence cross‑functional stakeholders and present insights to all levels of senior stakeholders
Demonstrated continuous improvement mindset, driving efficiencies, process improvements across diverse initiatives
Strategic thinker with strong results‑orientation and sense of urgency to deliver quality results on time and in a highly ethical and professional manner
A problem solver with a hands‑on approach, possessing business acumen and the ability to anticipate business and organizational needs
Resilient and able to work well in an ambiguous, demanding, fast paced entrepreneurial environment
Pay Range $160,000 - $240,000
Disclosure 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 Eligible
Flex 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 Vertex's 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 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.
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.
#J-18808-Ljbffr