Total 11 job vacancies by Vertex Pharmaceuticals Inc (US)

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Job Description

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Job Description

GENERAL SUMMARY:

The Sr. Specialist, Manufacturing Technical Operations (MTO) is responsible for ownership of deviations and CAPAs for MTO Team supporting Vertex Cell and Gene Therapy (VCGT) manufacturing operations at our Boston, Cambridge, and Providence sites. The Sr. Specialist, MTO is responsible for owning, planning, and driving all aspects of deviations in the electronic quality management systems (eQMS) as part of the MTO compliance center of excellence. This role also aims to support our growing MTO team with ownership and support of corrective and preventive actions (CAPAs), change controls and analytical investigations. This position will enhance efficiency by ensuring best practices are implemented and mentoring junior MTO staff. This role is an on-site position in our Boston location. This role is a flex/second shift position that will require some ad-hoc weekend work to support our clinical manufacturing timelines.

KEY DUTIES AND RESPONSIBILITIES:

• Triage unplanned deviations in real-time with cross-functional team to determine immediate actions taken to support real time release.
• Lead, write and review deviations for VCGT, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
• Identify and assemble proper SMEs for root cause analysis working sessions for unplanned deviations.
• Own and track quality events including deviations, analytical investigations for VCGT CMC including Manufacturing, Quality Control, Facilities, Supply Chain and Material Management.
• Mentor junior MTO staff including resident contract resources by peer reviewing draft deviations and CAPAs prior to quality review.
• Support other MTO teams as needed including change control, risk assessments, training and documentation. Ensure all timelines and due dates are achieved.
• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.
• Provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.
• Demonstrate the Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
• Other duties and projects as assigned to meet departmental requirements.

EDUCATION AND EXPERIENCE:

• BS/MS in chemical, mechanical, or material science engineering.
• 4+ years progressive experience in pharmaceutical development and manufacturing.
• Understanding of science and technology of GMP manufacturing environment, preferably Cell and Gene Therapy or related. 
• Understanding of the science and technology of cell and gene therapies.
• Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs.
• Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.
• Experienced with technical writing and performing event investigations in a GMP-compliant environment.
• Excellent verbal and written communication skills.

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Job Description

Principal Scientist, MSAT – Materials Science, Vertex Pharmaceuticals (Boston)

The Principal Scientist Manufacturing Science and Technology (MSAT) – Materials Science will support the Vertex Cell and Gene Therapy (VCGT) manufacturing network by applying a deep understanding of relationships between materials properties, process conditions, and final product quality. The role will have a proven track record of applying in-depth conceptual knowledge of materials science and engineering principles to materials and improved process understanding, with in-depth knowledge of one or more relevant areas applicable to cell and gene therapies.

Key Responsibilities:

• Represent the MSAT function in cross-functional teams as a materials science technical subject matter expert for single-use systems, cell culture media, and/or small/large molecule raw materials.
• Support and champion continuous improvement and technical innovation within the VCGT network with respect to raw materials.
• Establish procedures and business processes to conduct raw material technical assessments, support onboarding new materials and technologies, alternate material sources, as well as supplier-initiated material change notifications.
• Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigations.
• Liaise with technical leads from other programs and functions to build collective cell and gene therapy knowledge.
• Engage industry to identify best practices and improvement opportunities.

Minimal Requirements:

• Requires at least 4 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience
• Advanced degree (MS/ Ph.D./ Eng Doc) in Science/Engineering or equivalent is essential
• Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule materials.
• 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 (CMOs), suppliers and service providers.
• Ability to travel, nationally and internationally, up to 10 - 15%.
• Flexibility to work on site a minimum of 3 days per week

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Job Description

The Principal Scientist, Aseptic Control, is recognized as having expertise in the principals and application of sterile and low bioburden processing technologies and providing technical support for manufacturing of cell and gene therapy (C&GT), small molecule, and combination medical device programs within cCMP manufacturing. This aseptic processing SME will partner with stakeholders to define strategies for microbial control of activities such as gowning, facility monitoring programs (EM, Water, Gases, etc.), disinfectant efficacy, aseptic processing simulations, filtration, particulate control, risk assessments, and will ensure the control strategies comply with industry guidance. The individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and will also assist in significant manufacturing investigations involving aseptic and/or low bioburden processing and facility monitoring programs. This role will report to the Director of Aseptic Control within Manufacturing Science and Technology (MSAT) Process team for Biopharmaceutical Sciences and Manufacturing Operations (BSMO). This position will be based in Vertex’s corporate headquarters in Boston, MA (Hybrid eligible working arrangement where flexibility in on-site working is available).

The incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D of Vertex on the design of processes and technologies required to produce aseptic and/or low bioburden drug products to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. In addition, the successful candidate will support the implementation of risk-based design and controls for low bioburden process operations for production of drug substance/intermediates for manufacturing. The successful candidate will be experienced in the field of aseptic process technologies (drug product and drug substance) including simulations, filter integrity, microbial testing strategies, microorganism characterization, aseptic technique and clean room facility monitoring programs.

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

Key Responsibilities:

• Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions. 
• Strong collaboration in the resolution of manufacturing investigations related to aseptic control events
• Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites. 
• Support of regulatory submissions and pre-approval inspection activities related to contamination control and prevention and control strategies for aseptic operations.
• Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment. 
• Establish processes and capabilities to provide technical stewardship of control strategies post-approval including establishing performance monitoring capability and troubleshooting/ out of conformance event resolution. This will involve partnering closely with external contract manufacturing and testing organizations to establish processes to monitor test process performance and continuous improvement initiatives. 
• Adherence to the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.

Required Qualifications:

• At least 10+ years of experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products, and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
• Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills.  Prior experience supporting drug product manufacturing activities across multiple modalities (e.g., sterile dosage form, devices, etc.) and design of sterility assurance and facility monitoring programs is desired.   
• Experience with root cause analysis and deviation management
• A proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations.
• Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations
• Strong knowledge of cGMP requirements
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide
• Excellent team player and be able to build and sustain organization respect and trust at all levels
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve Keeps current on professional knowledge, expertise and best practice; influential in the external environment in the area of aseptic processing and participates in industry consortia/ conferences relevant to the field.

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Job Description

Description:

The Manufacturing Operations Senior Associate will assist in the day-to-day manufacturing operations at the Leiden Center 1 (LC1) facility. Under supervision, the incumbent will be working in the Clinical Manufacturing facility performing aseptic operations inside a BSC working in a GMP environment. The Manufacturing Operations Senior Associate is a critical hands-on role within Cell Manufacturing. This position is responsible for GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have extreme attention to detail, dedication to patients, and drive to learn.

This role requires the understanding of and strict adherence to cGMP requirements for cell processing operations involving adherent and suspension cell cultures. The successful candidate will read and interpret Batch Records, SOPs, policies and other relevant work instructions to ensure successful and compliant drug substance manufacturing. In this role, you will also collaborate with Facilities/Operations, Quality, EH&S, Materials Management and related stakeholders to drive efficient manufacturing operations.

The schedule for this role is First Shift (7AM – 4PM). Work shift is Tuesday – Saturday (40hrs)

Key Duties and Responsibilities:

• Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations. 

• Demonstrates and assists others with aseptic technique. 

• Ensures raw materials are identified and available in time for manufacturing activities. Transfer raw material inside cleanroom suite using sanitizing reagents. 

• Supports Operations group to ensure proper coordination of resources. 

• Ensures cGMP compliance through consistent execution. 

• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

Knowledge and Skills:

• Ability to follow verbal and written instructions 

• Minimum 1 year of experience in a GMP environment 

• Minimum 6 months experience with cell culture and demonstration of aseptic technique 

• Basic computer skills Word, Outlook, and equipment interfaces

Education and Experience:

• High School degree and 3 years of experience, or the equivalent combination of education and experience in a related field

• Ability to follow verbal and written instructions in English

• Solid communication and documentation skills

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Job Description

Description:

The Manufacturing Operations Specialist will lead and assist in the day-to-day manufacturing operations at the Leiden Center 1 (LC1) facility. The incumbent will be working in the Clinical Manufacturing facility under a GMP environment supporting aseptic operations inside a BSC and assisting others in various tasks ensuring continuous manufacturing production. The Manufacturing Operations Specialist is a critical hands-on role within Cell Manufacturing. This position is responsible for GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have extreme attention to detail, dedication to patients, and drive to learn and ability to lead a team along with training their peers.

This role requires the understanding of and strict adherence to cGMP requirements for cell processing operations involving adherent and suspension cell cultures. The successful candidate will read and interpret Batch Records, SOPs, policies and other relevant work instructions to ensure successful and compliant drug substance manufacturing. In this role, you will also collaborate with Facilities/Operations, Quality, EH&S, Materials Management and related stakeholders to drive efficient manufacturing operations.

The schedule for this role is First Shift (7AM – 4PM). Work shift is Sunday – Thursday (40hrs)

Key Duties and Responsibilities:

• Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations. 

• Demonstrates and assists others with aseptic technique. 

• ·May participate in technology transfer and final process development from the Development to the Manufacturing group. Occasionally supports the development of Standard Operating Procedures (SOPs) or other documentation for manufacturing in collaboration with Development and Quality groups. 

• Ensures raw materials are identified and available in time for manufacturing activities. Transfer raw material inside cleanroom suite using sanitizing reagents. 

• Supports Operations group to ensure proper coordination of resources. 

• Ensures cGMP compliance through consistent execution. 

• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

• Other duties and projects as assigned to meet departmental requirements.

Knowledge and Skills:

• Ability to follow verbal and written instructions 

• Minimum 1 year of experience in a GMP environment 

• Minimum 6 months experience with cell culture and demonstration of aseptic technique 

• Basic computer skills Word, Outlook, and equipment interfaces

Education and Experience:

• High School degree and/or 3+ years of experience, or the equivalent combination of education and experience in a related field

• Ability to follow verbal and written instructions in English

• Solid communication and documentation skills

Company Information

Job Description

Description:

The Manufacturing Operations Specialist will lead and assist in the day-to-day manufacturing operations at the Leiden Center 1 (LC1) facility. The incumbent will be working in the Clinical Manufacturing facility under a GMP environment supporting aseptic operations inside a BSC and assisting others in various tasks ensuring continuous manufacturing production. The Manufacturing Operations Specialist is a critical hands-on role within Cell Manufacturing. This position is responsible for GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have extreme attention to detail, dedication to patients, and drive to learn and ability to lead a team along with training their peers.

This role requires the understanding of and strict adherence to cGMP requirements for cell processing operations involving adherent and suspension cell cultures. The successful candidate will read and interpret Batch Records, SOPs, policies and other relevant work instructions to ensure successful and compliant drug substance manufacturing. In this role, you will also collaborate with Facilities/Operations, Quality, EH&S, Materials Management and related stakeholders to drive efficient manufacturing operations.

The schedule for this role is Second Shift (2PM – 10PM)

Work shift is Tuesday – Saturday (40hrs)

Key Duties and Responsibilities:

• Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations. 

• Demonstrates and assists others with aseptic technique. 

• Ensures raw materials are identified and available in time for manufacturing activities. Transfer raw material inside cleanroom suite using sanitizing reagents.  Supports Operations group to ensure proper coordination of resources. 

• Ensures cGMP compliance through consistent execution. 

• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

Key Duties and Responsibilities:

• Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations. 

• Demonstrates and assists others with aseptic technique. 

• May participate in technology transfer and final process development from the Development to the Manufacturing group. Occasionally supports the development of Standard Operating Procedures (SOPs) or other documentation for manufacturing in collaboration with Development and Quality groups. 

• Ensures raw materials are identified and available in time for manufacturing activities. Transfer raw material inside cleanroom suite using sanitizing reagents. 

• Supports Operations group to ensure proper coordination of resources. 

• Ensures cGMP compliance through consistent execution. 

• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

• Other duties and projects as assigned to meet departmental requirements.

Knowledge and Skills:

• Ability to follow verbal and written instructions 

• Minimum 1 year of experience in a GMP environment 

• Minimum 6 months experience with cell culture and demonstration of aseptic technique 

• Basic computer skills Word, Outlook, and equipment interfaces

Knowledge and Skills:

• Ability to follow verbal and written instructions 

• Minimum 1 year of experience in a GMP environment 

• Minimum 6 months experience with cell culture and demonstration of aseptic technique 

• Basic computer skills Word, Outlook, and equipment interfaces

Education and Experience:

• High School degree and/or 3+ years of experience, or the equivalent combination of education and experience in a related field

• Ability to follow verbal and written instructions in English

• Solid communication and documentation skills

Company Information

Job Description

General Summary:

The Supervisor, Manufacturing Operations leads shift work in the cell therapy clinical manufacturing facility, assigning work according to detailed schedules and plans. Responsible for daily cGMP operations in the Vertex Drug Product Facility, including the set-up, assembly, operation, disassembly, and cleaning of process equipment, and overseeing the daily work of shift personnel.

Responsible for daily operations and staff allocations for first shift personnel.

Key Duties and Responsibilities:

• Interface with relevant cross functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product.

• Execute and witness batch record instructions during cGMP operations.

• Maintain facility in an audit ready state.

• Supervise manufacturing personnel

• Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility.

• Maintain compliance with all on-going training requirements.

• Follow SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility.

Knowledge and Skills:

• A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment.

• Ability to follow verbal and written instructions in English.

• Visual Acuity.

• Ability to distinguish between the colors red, yellow, blue and green.

• Ability to lift up to 50lbs.

• Strong organizational skills.

• Strong communication skills, as well as excellent documentation skills.

• Basic computer skills and demonstrated ability to learn new systems and understand new technologies.

• Occasional availability to work on other shifts may be necessary for onboarding and training.

Experience:

• Typically requires 3 years of relevant work experience or the equivalent combination of education and experience

• Supervisory experience

• Experience with manufacturing systems utilizing computerized control systems and HMIs

• Experience with continuous manufacturing and with manufacturing processes relevant to cell and gene therapy

Company Information

Job Description

The External Manufacturing Senior Manager will drive manufacturing operations and execution at Vertex’s external commercial partner(s) for the manufacture of Small Molecule Drug Product, while contributing to the broader External Manufacturing group activities. The candidate will be in a remote role, with travel to US and EU CDMO sites routinely as a “Person-in-Plant” 2-4 weeks per month.

Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain (CMSC) team’s role in ensuring that Vertex effectively and efficiently delivers medicines to patients. As such, we are looking for a leader to provide leadership, and both strategic and enterprise thinking in the management of the external partner.  The candidate should have broad professional experience and the drive to work with both internal and external stakeholders to define and manage the execution of ongoing cGMP manufacturing of Drug Product supplies. This leader should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  They should have the ability to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

Key Responsibilities:

• Acts as main point of contact for CDMO(s), building and maintaining strategic relationships within the CDMO organization.  
• Responsible for driving execution of Drug Product production plans: Provide operational oversight and troubleshooting support 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).   
• Maintain on-site presence acting as the Person-in-Plant (PiP) at the CDMO facility and be Vertex’s eyes and ears to ensure flawless execution of commercial operations. This may include some off-hours/days to resolve urgent issues.
• Lead continuous improvement initiatives to affect timely resolution of supply issue and increase productivity.
• Partners with Tech Ops, Quality and CMSC Strategy and Business Operations to champion a culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements.
• Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
• Leads identification and resolution of business-critical and contract issues; leading escalations to CMSC and Quality leadership.
• Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.

Minimal Requirements:

• BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline
• Requires 8 years or more of relevant experience in biotech/pharmaceutical industry. 
• Understanding of the science and technology underlying Small Molecule Drug Product manufacturing as well as analytical techniques that support commercial manufacturing activities.
• Demonstrated understanding of the technical aspects of manufacturing, testing, and controls; engineering; plant operations; the regulations governing pharmaceutical operations, as well as financial systems and controls.
• Strong quality and compliance background in a commercial GMP operational environment
• A strategic thinker with strong result-orientation, and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor.
• Excellent team player and be able to build and sustain organization respect and trust at all levels both internally and externally.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment.
• 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.
• Flexibility to work shift hours required to cover critical process steps and troubleshooting.
• Ability to travel, national and international, up to 100%
• Experience in aseptic manufacturing operations

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Salary range: $132,800 - $199,200 annually

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. 

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Job Description

External Manufacturing Sr. Manager, Person in Plant (Finished Goods)

The primary focus of the Sr. Manager role is to oversee operations of Vertex’s external US commercial partner(s) for the manufacture of small molecule finished goods products. The incumbent will lead the internal virtual plant team that oversees the operations at the CDMO and co-lead joint project teams with the CDMO, while contributing to the broader External Manufacturing group activities. The candidate will be located close to the US CDMO site(s) outside of Philadelphia, PA and/or be able to travel to those sites 3 days/week as a “Person-in-Plant”.

Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team’s role in ensuring that the company effectively and efficiently delivers medicines to patients.  As such, we are looking for a leader to provide vision, leadership, and both strategic and enterprise thinking in the management of the external partner.  The candidate should have broad professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of finished goods. The Sr. Manager will provide vision, leadership, and strategic thinking in the management of the external partners. This leader will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

The Sr. Manager will report directly to the Director, External Manufacturing Operations. This leader should have a strong operational, quality, compliance, and technical background, with proven project management and supplier management abilities.  They should have the ability to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.  

The candidate will be in a remote role, with travel to CMO sites routinely as a “Person-in-Plant”. This role will be accountable for all Finished Goods external commercial manufacturing operations activities in the US for small molecules. This role will partner closely with colleagues across Vertex to ensure a seamless supply of all Finished Goods commercial products. 

Key Responsibilities:

• Acts as the main point of contact for CDMO(s) including the leader of the CDMO VPT/working team. 
• Responsible for driving execution of commercial and late stage/launch production plans: provide operational oversight, and troubleshooting support, 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).  
• Maintain on-site presence acting as the Person-in-Plant at the CDMO facility and be Vertex’s first point of contact to ensure flawless execution of commercial operations. This may include some off-hours/days to resolve urgent issues.
• Lead continuous improvement initiatives to affect the timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Partners with Tech Ops, Quality, and CMSC Strategy and Business Operations champion a culture of quality with our CDMOs and ensure that all activities and documentation comply with regulatory requirements.
• Monitor CMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
• Supports identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy+Bus Ops, Strategic Sourcing).
• Partners with Global Supply Chain to develop a long-term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.
• Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.

Minimal Requirements:

• 8+ years of progressive experience in a leadership/management role in pharmaceutical development and commercial manufacturing
• Understanding of the science and technology underlying Finished Goods manufacturing as well as analytical techniques that support commercial manufacturing activities
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering
• Strong knowledge of cGMP requirements
• A strategic thinker with a strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
• Excellent communication and interpersonal skills with the ability to work in strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
• Excellent team player and able to build and sustain organizational respect and trust at all levels
• Problem solver with a hands-on approach and the ability to anticipate adverse scenarios and provide contingency plans to address them
• Resilient and able to work well in a demanding, fast-paced entrepreneurial environment
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
• Keeps current on professional knowledge, expertise, and best practice.

#LI-SV1

#LI-Remote

Salary range: $132,800 - $199,200 annually

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. 

Company Information