Director, Project Management
Editas Medicine, Inc. job in Cambridge, MA
At Editas Medicine, we are pioneering the possible. Our mission is to translate the power and potential of CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we're a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected and where you can operate at the forefront of gene editing, become an Editor!
This role is to help advance our lead in vivo development candidate, EDIT-401, a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates. If you are a candidate excited to help push the boundaries of what's possible in medicine, apply now.
Decoding The Role:
The Director, Project Management will lead the planning and execution of the cross-functional workstreams from pre-IND through to commercial launch. This role is responsible for leading cross functional partners in the development of a detailed program timeline in Smartsheet, clear functional budgets, and an aligned view of the program critical path. The Director, PM role will manage the weekly Program team meeting to ensure seamless cross-functional coordination of workstreams, to identify and mitigate program risks, and to successfully deliver to key program milestones (Pre-IND, IND, Phase I, II, and transition to registrational study). The ideal candidate will bring deep experience in clinical trial operations and project management within biotech or pharmaceutical settings, particularly in gene therapy programs.
This position will operate in a highly matrixed, fast-paced biotech environment from Editas's Cambridge, MA headquarters. An ideal candidate demonstrates:
* Strong communication skills: this candidate is able to effectively partner with internal and external stakeholders across the team. This candidate balances inquiry with advocacy when engaging with teammates to ensure he/she fully understands a situation before engaging in problem solving.
* Organizational skills: this candidate is a detailed oriented planner, diligently confirming and aligning the functional plans of her / his peers. This candidate has a track record of establishing program structure; he / she enables a logical, process-driven approach to enhance collaboration across teams.
* Teamwork and leadership: This candidate possesses a highly collaborative mindset and is skilled at productive debate that builds team commitment to a recommended path forward. This candidate tests functional thinking and respectfully challenges his/her teammates to get to reasonable program assumptions.
* Adaptability: This candidate has demonstrated the ability to balance multiple priorities and adapt their approach to be successful in a fast paced, dynamic biotech environment.
Characterizing Your Impact:
As the Director, Program Management , you will:
* Lead the operational planning and execution of the cross-functional program plan; establish and reinforce a Program structure that enables cross-functional collaboration
* Develop detailed project plans including timelines, milestones, interdependencies, budgets, and the Program Team critical path
* Coordinate activities and deliverables across functional teams including Clinical, Non-clinical, Regulatory, CMC, and Data Management.
* Track progress against plans, identify risks, and implement mitigation strategies.
* Provide regular updates to leadership and governance committees.
The Ideal Transcript:
To thrive in this role, you'll need:
* A minimum of a bachelor's degree in life sciences or related subjects; advanced degrees (MBA) are desirable.
* 8-10 years of experience in biotech/pharma, with 3-5 years in program management supporting early-stage clinical development. Experience managing multiple programs at the same time is desirable.
* Proven track record of leading cross-functional teams in a matrixed environment.
* Strong understanding of preclinical development, IND-enabling studies, and early clinical trial operations. Experience across functional roles is desirable.
* Experience with gene therapy or gene therapy programs is highly desirable.
* Mastery of project management tools and methodologies, including Smartsheet, Microsoft Project, and OnePager
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
$210,000 - $230,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor?
We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
Director, Toxicology
Editas Medicine, Inc. job in Cambridge, MA
At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we're a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what's possible in medicine, come join us and become an Editor!
Decoding The Role:
Editas Medicine is seeking a highly accomplished and experienced toxicologist, and a seasoned leader to join our DMPK, Nonclinical Safety and Translational Sciences (DSTS) team. In this leadership role, you will serve as the Head of Toxicology within Editas and be responsible for overseeing all nonclinical safety assessment related activities in rodent and non-rodent models. The successful candidate will apply their knowledge, expertise and drug development experience to advance our gene editing pipeline. The responsibilities include developing and implementing comprehensive strategies to fully integrate with the programs team objectives at all stages of development. The ideal candidate will have strong technical skills, a broad understanding of drug discovery and development, strong foundational knowledge and ability to work collaboratively with key partners in a matrix team structure. The individual in this role should be an independent thinker, collaborative, possess team-player mindset, and ability to thrive in a fast-paced environment. Prior experience with lipid nanoparticle based (LNP) delivery systems and/or gene editing products is a plus. The individual in this critical role will be an integral part of the nonclinical leadership team and will have the opportunity to help build the department to meet the business needs and to bring life changing therapies to patients with genetic disorders.
Characterizing Your Impact:
As the Director, Toxicology you will:
* Develop phase-appropriate nonclinical safety strategies and execution to support Editas' pipeline.
* Lead the design and oversee execution of GLP and non-GLP toxicology studies to support regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications
* Manage CRO relationships and collaborate with the internal team to drive CRO selection, study monitoring and reporting to ensure scientific rigor, meeting timelines, budgets, and regulatory compliance
* Deliver high-quality safety reports to support clinical plans and regulatory filing submissions in multiple markets
* Serve as the toxicology and/or nonclinical representative (provide subject matter expertise) in cross-functional meetings both internally and externally
The Ideal Transcript:
To thrive in this role, you'll need:
* PhD in toxicology, pharmacology or related field (preference for DABT certified) with 10+ years of industry experience
* Core expertise in toxicology with emphasis on general toxicology, genotoxicity, developmental and reproductive toxicology
* Track record of advancing programs through nonclinical development including managing GLP and non-GLP studies, and regulatory submissions
* Familiarity with FDA/EMA/ICH guidelines and proven track record of successful health authority interactions
* Experience with gene editing or gene delivery technologies and lipid nanoparticle delivery is highly desired
* Preference will be given to candidates who demonstrate deep interest in translational toxicology
* Outstanding communication skills, both written and oral, and an ability to constantly adapt in a fast-paced dynamic biotech environment
* Desirable personal attributes include strong organization skills, positive attitude, highly collaborative mindset and attention to detail.
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
$220,000 - $240,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
Channel Sales Representative- Life Science Discovery Products( Massachusetts)
Cambridge, MA job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Mirus Bio (now part of MilliporeSigma) is a leading provider of life science products, committed to advancing research, development, and healthcare solutions. We work with top-tier organizations in the life sciences field, providing cutting-edge technologies and expertise. We are seeking an experienced and results-driven Channel Sales Representative to join our team and support the growth of our life science product offerings across a broad network of distribution partners.
Your Role:
The Channel Sales Representative- Life Science Discovery Products, will be critical in driving sales and expanding the market share for our life science products. This individual will be responsible for building and maintaining strong relationships with distribution partners, managing sales strategies, and identifying new opportunities for growth in the life science sector. The ideal candidate will have experience in sales within the life sciences or healthcare industry and a proven track record of success in channel sales management.
Develop and Manage Direct and Distribution Channels: Drive sales for Life Science Discovery and manage relationships with distribution partners in key markets, ensuring alignment with company goals and product offerings. Where appropriate identify and recruit new distributors.
Sales Strategy Execution: Work closely with internal teams to develop and implement sales strategies aimed at achieving revenue targets and expanding market presence within the life science sector for both distribution and direct business
Product Knowledge: Maintain in-depth knowledge of the company's product portfolio, staying up to date on product advancements and market trends to provide valuable guidance to distributors and clients.
Customer Engagement: Provide exceptional support to distribution partners, offering training, troubleshooting, and guidance to ensure their success in selling life science products. Where appropriate, support our direct customer base.
Sales Reporting and Forecasting: Track sales performance, provide regular updates, and manage forecasts to ensure accurate revenue predictions and market penetration.
Market Analysis: Monitor and assess competitor activities, industry trends, and customer feedback to inform sales strategies and product improvements.
Promotional Support: Assist with the creation and execution of marketing and promotional campaigns to enhance product visibility and distributor engagement.
Travel: Regular travel to meet with distributors, attend industry events, and gather customer feedback. (20% of the time)
Minimum Qualifications:
Bachelor's degree in Biology, Chemistry, Business, or other Life Sciences discipline.
3+ years of sales experience, focusing on life science products or related industries like Academia, Biotech, and Pharma
Preferred Qualifications:
Ideally have a proven track record in managing distribution channels and achieving sales targets.
Strong understanding of life science product offerings and their applications.
Excellent communication, negotiation, and presentation skills.
Ability to work independently and as part of a team in a fast-paced environment.
Proficiency with CRM software and MS Office Suite (Excel, Word, PowerPoint).
Pay Range for this position: $68,700 - $139,200
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Vertex Fellow Boston
Boston, MA job
Job Posting: Vertex Fellows Program Flex Designation: On-Site Designated Application Deadline: January 9, 2026, by 5:00 PM ET Please submit a CV/resume and cover letter with your application. Letters of Recommendation will be requested if invited to interview.
About the Program
The Vertex Fellowship is a unique, one-year training program for outstanding scientists and physicians passionate about solving unmet medical needs and advancing transformative science. Fellows join Vertex for a customized post-doctoral experience, gaining hands-on experience with real-world R&D challenges and benefiting from mentorship by Vertex leaders.
This program is designed to provide participants with a broad understanding of the science and business of drug discovery.
Program Highlights
* Project-based Fellowship:
* Embed for one year within a Vertex project team
* Work on a project of relevance, based on your skills and our pipeline needs
* Training & Mentorship
* Intensive didactic training on the science and business of drug development
* Scientific mentorship from research leaders
* Career mentorship from Vertex leaders
* Exploring Career Fit
* Upon completion, participants will be able to effectively decide if a career in industry is the right fit, and if so, how they might develop their career
Why be a Vertex Fellow?
* Contribute to transformative medicines: Help patients by advancing scientific ideas in a team-based environment
* Accelerate your career: Learn about drug discovery and build your professional network
* Mentorship: Receive guidance from scientific, medical, and business leaders at Vertex
* Vertex Fellows Network: Develop connections internally and externally
Program Timeline
* Applications Accepted: November 24, 2025 - January 9, 2026, by 5:00 PM ET
* Interview Invitations: February 2026 (Letters of Recommendation requested at this time)
* Interviews: Early March 2026
* Formal Offers: Mid-late March 2026
* Program Start: September 2026
* Program End: August 2027
Eligibility Requirements
* PhD, MD, or joint degree attained within 0-5 years
* Demonstrated scientific impact (e.g., peer-reviewed publications, presentations, awards)
* Evidence of creative thinking, scientific problem solving, and innovation
* Interest in learning how scientific research leads to the development of therapies
Application Instructions
Please submit your CV/resume and cover letter by January 9, 2026, 5:00 PM ET.
In your cover letter, consider addressing:
* Your most significant scientific or research achievement and how you accomplished it
* An example of how you applied creative thinking to solve a problem
* What you hope to gain from the Vertex Fellows Program
Letters of Recommendation will be requested if invited to interview.
Pay Range:
$110,000 - $165,000
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:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
#LI-Onsite
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
Auto-ApplyVertex Spring 2026 Co-op, Single Cell Genomics
Boston, MA job
Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you'll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We're passionate about innovation, inclusion, and supporting your growth-inside and outside the lab.
Why Vertex?
Real Projects: You'll work on assignments that make a real impact, not just busy work.
Mentorship & Networking: Connect with leaders and peers who want to see you succeed through professional networks, connections, and collaborations that will shape your longer-term career.
Flexible & Supportive: We offer flexible work options with Flex @ Vertex and prioritize your wellbeing.
Inclusive Culture: Collaboration and inclusion are embedded in everything we do.
Career Launchpad: Build skills, explore career paths, and get guidance for your future career.
Ready to apply? Submit your application and let's turn possibilities into reality!
Your Impact
The Vertex Single Cell Genomics Co-Op program is a 6-month experiential training program for students currently working towards an advanced degree in Systems Biology, Developmental Biology, Stem Cell Biology, Biochemistry, Biological Engineering, Chemical Engineering, or other related fields. If you are passionate, collaborative, and growth-minded, a co-op at Vertex will help you gain meaningful experience in our analytical sciences functional areas and serve as a launchpad for your career.
Please note that Vertex reviews applications on a rolling basis and reserves the right to close this job posting prior to the listed deadline.
Important Notice Regarding Internship and Co-op Inquiries
At Vertex Pharmaceuticals, we are committed to providing a fair and structured recruitment process for all students interested in internship and co-op opportunities. To ensure consistency and equity, all student applications must go through our Early Talent Acquisition Team.
Due to the high volume of interest, we are unable to respond to individual solicitation. Direct solicitation to Vertex employees- including senior leaders via email will result in removal from the recruiting process.'
We appreciate your enthusiasm and interest in Vertex. To be considered for internship or co-op roles, please apply directly through our official application channels. (*********************************************************************
Thank you for respecting our process and helping us maintain a fair experience for all candidates.
What you will be doing:
The co-op student's primary role is applying bioinformatics skills to interpretate bulk and single cell RNA sequencing data to deepen our understanding of the stem cell differentiation process, and monitor the differentiation progress. Specifically, they will use bioinformatics tools, such as Seurat or Scanpy, to map time course differentiation trajectory and identify potential correct and wrong trajectories of our process. Using the knowledge gained in this activity, the candidate will then nominate lists of genes to enable development of other RNA-based assays to closely monitor stem cell differentiation process. The co-op student will also assist in wet lab construction of single cell RNA sequencing libraries, and operation of Illumina sequencers.
Key Deliverables at Project Completion:
Daily mapping of our differentiation process using available single cell RNA sequencing data.
A collection of wrong differentiation trajectories and a collection of potential failure modes identified by single cell RNA sequencing.
Lists of RNA targets to monitor correct and wrong differentiation trajectories.
Key Learnings Expected:
Skills on single cell RNA sequencing library construction, data analysis and data visualization.
Deeper understanding of developmental biology, stem cell biology, and stem cell engineering.
Presentation of large and complex data.
What you will need to succeed:
Enrolled in a graduate program in Systems Biology, Computational Biology, Developmental Biology, Stem Cell Biology, Biochemistry, Biological Engineering, Chemical Engineering, or another related field
Analysis, visualization, and interpretation of next-generation sequencing (NGS) data. Experience with Seurat, Scanpy, DESeq2 and other bioinformatics tools used for single cell RNA sequencing and bulk RNA sequencing data analysis is preferred.
Proficiency with R, Python, Linux systems, high-performance computing systems
Fundamental knowledge in developmental biology, stem cells and differentiation are preferred
Fundamental knowledge in sequencing library preparation and sequencer operation are preferred
A team-oriented growth mindset that welcomes feedback from others and supports other team members; strong collaboration skills to work across teams and functions
A positive attitude that enthusiastically tackles and overcomes challenges
Strong organizational and time-management skills to prioritize needs
Excellent presentation and communication skills, including the ability to tailor scientific content to audiences with different backgrounds
Legal authorization to work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization.
You must be enrolled in an advanced degree program if graduating before June 2026
You must be available to work full-time, 40 hours per week from January - June 2026
Program Details:
Full-time, paid co-op $26.00 - 50.00 USD/hour
Program Dates: January - June 2026
At Vertex, we believe that when you feel your best, you can perform at your best. That's why our US benefits and global well-being resources are designed to support you.
• Free 24/7 onsite gym access and free access to group exercise classes
• Subsidized commuter benefits- transit and parking
• Provided meals-free breakfast daily!
• Career development opportunities and events, including C Suite engagement
• Social events-both intern-only and company-wide
• Location-specific perks and extras!
• Recognition of National Intern Day
Our Ways of Working
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.
Equal Opportunities
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.
Vertex is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accessibility & Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Vertex is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role, Vertex is unable to sponsor non-U.S. persons to apply for an export control license.
This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer.
Pay Range:
$0 - $0
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
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
Auto-ApplyProcess Development, Associate Director - Cell Line Development (CLD), Biologics
Boston, MA job
Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics.
The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making.
Key Duties and Responsibilities:
* Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities.
* Evaluate, select and manage external capabilities for cell line development.
* Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies.
* Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation.
* Develop and manage project timelines and budget for CLD activites.
* Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals.
* Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer.
* Review and approve technical protocols, development reports, and data packages provided by CDMOs.
* Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners.
* Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD.
* Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.
* Expected travel: 10-20% (domestic and international)
Required Education:
* PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
* Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered.
Required Experience and Skills:
* Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins.
* Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred.
* Knowledge of upstream process development and analytical methods related to CLD.
* Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows.
* Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.).
* Proven track record of delivering on complex biologics development programs.
* Excellent interpersonal, communication, and organizational skills.
* Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment.
#LI-LE1
Pay Range:
$166,800 - $250,200
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:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
#LI-Onsite
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
Auto-ApplyMedical Specialist I-Gastroenterology (Boston)
Boston, MA job
The Medical Specialist I, Gastroenterology will report to the District Manager and will engage Gastroenterologists and other key customers within an assigned geography. We present clinically focused selling messages to create and grow revenue, consistently delivering product goals. The Medical Specialist will demonstrate strong and consistent sales performance that exceeds forecast and expectations related to product goals. We accomplish this in a compliant manner with a high degree of integrity strictly following all our policies and in compliance with all policies and procedures governing the promotion of pharmaceutical and biologic products in the US.
Territory: Boston, MA
A typical day may include:
* Developing a strategy and implementing tactics within key accounts in the Gastroenterology therapeutic area generating product utilization.
* Develop strong working relationships with Gastroenterology experts and others as well as nurses, office staff and other important health care personnel and key patient advocacy support groups.
* Collaborate with our regional colleagues, other field-based home office teams to proactively address customer needs, market dynamics and trends. Develop strategies which support brand and corporate objectives within their assigned geography.
* Participating in and help lead initiatives to support sales success as assigned (e.g. participate in industry-related local and regional meetings and medical conferences).
This may be for you if you:
* Can demonstrate advanced clinically based selling skills
* Have proven success and positive track record of consistent sales performance in complex markets.
* Experienced with customer segments operating within compliance guidelines
* Are results oriented with a proven track record of success with product launches
To be considered you must have a BA/BS in science or business (master's degree a plus). A minimum of 5 years' sales experience in the Pharmaceutical or Biotechnology industry. Previous gastroenterology or biologics experience preferred. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends Experience with in-servicing and training office staff, nurses and office managers
Must be based in or located near the assigned territory (relocation will not be provided). Ability to travel (30-50%)
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$143,500.00 - $187,500.00
Auto-ApplyQuality Control Senior Specialist
Boston, MA job
Employer: Vertex Pharmaceuticals Incorporated JOB TITLE: Quality Control Senior Specialist OPENINGS: 1 * Provide a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples.
* Ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
* Serve as RSL representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs.
* Coordinate and facilitate laboratory activities to meet commitments on-time.
* Maintain accurate laboratory records and adhere to cGMP/GDP expectations.
* Participate in planning, executing and/or review of method validations, method transfers and/or equipment qualification/requalification
* Assist in troubleshooting of analytical methods and/or equipment as required.
* Authors, reviews, and/or approve data, SOPs, COAs, analytical methods, protocols and reports.
* Lead compliance related teams working towards the goal of continuous improvement.
* Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs.
* Lead the OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence.
REQUIREMENTS: Employer will accept a Bachelor's degree, or foreign equivalent, in health science, pharmaceutical sciences or a related field and 5 years of experience in the job offered or in a Quality Control Senior Specialist-related occupation.
Position requires demonstrable experience in the following:
Knowledge of US and EU cGMP regulations, guidance and experience with regulatory agency inspections. In-process, release, and stability testing and review independently following established methodology, procedures, and SOPs. Participating in analytical method validation protocol discussions and lead planning and execution and review of method validations and method transfers. Ensuring accurate laboratory records and adhering to cGMP/GDP expectations. Troubleshooting analytical methods and analytical equipment as required. Investigating OOT/OOS results and other deviations. Knowledge of analytical methodologies including
HPLC with Empower software.
Karl Fisher.
Dissolution.
FTIR spectrophotometry.
UV-VIS Spectrophotometer.
Rate of Pay: $94300.00 - $141400.00
CONTACT: Send Resume to *********************. Reference 12140.644. EOE.
#LI-DNI
Pay Range:
$0 - $0
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:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
#LI-Onsite
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
Auto-ApplyAnalytical Development Principal Research Associate
Boston, MA job
Employer: Vertex Pharmaceuticals Incorporated JOB TITLE: Analytical Development Principal Research Associate OPENINGS: 1 * Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products. Multiple analytical platforms will be employed including RT-qPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry, Flow-cam, dd PCR, Alphalisa and cell- based functional/ potency assays.
* Execute test methods in support of pluripotent stem cell Process Development activities.
* Troubleshoot, optimize, and trend assay performance.
* Report on project progress, write analytical development protocols and reports, provide recommendations to management.
* Identify, qualify, and manage analytical reagents as per regulatory standards.
* Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
* Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods.
* Establish reference standard materials as required to support assay validation.
* Transfer assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports.
* Maintain excellent written documentation (e.g. lab notebook and test forms).
REQUIREMENTS: Employer will accept a Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 2 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.
Alternatively, employer will accept a Bachelor's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 6 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.
Position requires demonstrable experience in the following:
Developing analytical methods in compliance with ICH guidelines. Assisting with the following assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays. Assisting with the culture of multiple mammalian cell types and combination drug product (Cells + device) Using literature to design proof of concept studies. Writing technical documents including development reports, qualification protocols and qualification reports.
Rate of Pay: $88300.00 - $132400.00
CONTACT: Send Resume to *********************. Reference 12140.579. EOE.
#LI-DNI
Pay Range:
$0 - $0
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:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
#LI-Onsite
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
Auto-ApplyDirector, Drug Product Process Development - Biologics
Boston, MA job
Biologics, Cell and Gene Therapy is a rapidly growing part of Vertex Pharmaceuticals where research, development, and clinical manufacturing are highly integrated together at our new R&D site in Boston Seaport. Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead the development and manufacturing of biologics drug products for our growing pipeline. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics.
The successful candidate will lead the development and manufacturing of biologics drug products. The responsibilities include formulation development, primary container development, fill-finish process development, technology transfer of manufacturing processes to CDMOs, and process validation to support our clinical pipeline toward commercialization. This is a highly cross-functional role that will work closely with drug substance development, analytical development, device development and supply chain management in CMC teams to drive technical and strategic decision-making.
Key Duties and Responsibilities:
* Lead phase-appropriate strategies for drug product development, process transfer, scale-up and process characterization to support commercial readiness.
* Set-up and oversee external capabilities for developability assessment and formulation screening for high concentration biologics, ADCs and other biologics modalities.
* Define and develop robust fill-finish manufacturing processes for liquid and lyophilized drug products in vials, pre-filled syringes and other novel primary packaging.
* Oversee drug product technology transfer, process development and GMP manufacturing operations at CDMOs.
* Define and develop clinical dose preparation and administration strategies for drug products for multiple indications. Collaborate with clinical and supply chain teams to prepare clinical study documentation.
* Collaborate with the device development team to develop combination product presentations such as pre-filled syringes, autoinjectors and advance delivery technologies.
* Define and implement drug substance and drug product stability and shelf-life assessment approaches.
* Develop and manage project timelines, resource allocation, and budget for drug product programs.
* Manage deviations and OOT/OOS investigations at the CDMOs in collaboration with Quality, External Manufacturing and Regulatory team.
* Define and implement control strategies, validation protocols, and process characterization studies in accordance with Quality by Design (QbD) principles.
* Author and review regulatory submissions: IND/IMPD, briefing books and BLA.
* Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.
* Identify and implement innovative technologies and best practices to improve process robustness, efficiency, and compliance.
* Potential in the future to build and manage a team of scientists and engineers to deliver high-quality, scalable, and compliant drug product processes from early development through commercialization.
* Expected travel: 10-20% (domestic and international)
Required Education:
* PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
* Minimum of 11 years of experience in drug product development and manufacturing. MS with 14+ years of relevant experience may be considered.
Required Experience and Skills:
* Expertise in formulation development of recombinant proteins including antibodies, ADCs, and fusion proteins.
* Expertise in developing stable, high concentration liquid formulation and dosage forms for biologics and applying cutting-edge technologies to develop stable drug products.
* Deep knowledge in developing aseptic fill-finish manufacturing process for biologics drug products in vials, pre-filled syringe and cartridge presentation.
* Experience successfully delivering development programs with CDMOs.
* Proven track record of advancing drug products from INDs into late phase development and commercialization.
* Experience with process characterization, process control strategy establishment and process performance qualification for commercialization using Quality by Design (QbD) principles.
* Extensive knowledge of cGMPs and regulatory guidelines for biologics and can serve as an internal thought-leader to drive decision making.
* Strong data analysis and scientific communication skills, including experience with regulatory documentation, with the ability to influence and drive decision making at multiple levels within a CMC organization.
* Demonstrated leadership with experience managing technical staff (internal or external) and cross-functional collaborations.
#LI-LE1
Pay Range:
$195,500 - $293,200
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:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
#LI-Onsite
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
Auto-ApplyLaboratory Equipment IT Engineer, Regeneron Cell Medicines
Cambridge, MA job
We are seeking a motivated **Laboratory Equipment IT Engineer** to support and maintain Building Management, Clinical Manufacturing Equipment and data acquisition/monitoring systems that support Clinical Manufacturing and Research and Development (R&D). This role is a part of Regeneron Cell Medicines (RCM), a newly formed R&D unit within Regeneron to advance cell therapies and combination approaches in oncology and immunology. We hope you are excited to serve as the technical SME as well as operate at the system administration, engineering, and management levels.
**As an Laboratory Equipment IT Engineer, a typical day might include the following:**
+ Supporting all manufacturing and QC equipment within RCM's 30,000 SF Phase 1 clinical manufacturing facility
+ Maintaining System documentation, including converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans, and summary reports
+ Leading IT Applications systems security access and periodic audit trail reviews
+ Performing investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software
+ Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements
+ Supporting automation activities by updating/authoring system specifications, user and functional requirements specifications, as well as generating and implementing necessary FAT and SAT protocols
+ Designing and developing test plans and implementing software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
+ Ensuring systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO; perform recovery of data as needed
+ Creating and maintaining configuration specifications for cGMP software for process control, monitoring and testing
+ Ensuring systems remain in compliant state including process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments
+ Supporting system integration with existing systems (ex. LIMS, Historian) as required by business needs
**This role might be for you if you:**
+ You enjoy working in a fast-paced environment and can be flexible with changing priorities
+ You thrive in a team-based, multi-functional, collaborative environment
+ You possess a problem-solving mentality
+ You have excellent verbal and written communication skills
**In order to be considered for this role,** you must have at least a Bachelor's degree in Information Technology or related field and 3-5 years of relevant experience in a manufacturing/lab/IT setting. Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility. Must have experience with automated systems for environmental monitoring and compliance; Rees is preferred. Experience working in a GMP environment is very advantageous.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$79,100.00 - $129,100.00
Senior Bioprocess Engineer
Burlington, MA job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
Work on a cross-functional team to deliver application studies using MilliporeSigma product portfolio.
Plan, set up, and execute laboratory experiments to evaluate the performance of new technologies, or new product or component prototypes for given application scenario.
Define process control strategies and design recipes and methods for optimal operation of MilliporeSigma product offerings.
Research literature and attend conferences to keep current with the bioprocessing end user's process design targets, performance expectations, and general bioprocessing needs.
Deliver internal and external written literature and presentations evaluating product designs and/or summarizing experimental results with a focus on technical performance.
Who You Are
Minimum Qualifications:
You have experience with setting up and executing downstream unit operations including Chromatography, normal flow filtration and Tangential Flow filtration.
Prior experience in analytical methods and high throughput platforms with respect to downstream process development.
PhD in Biological or Chemical Engineering or a related discipline AND at least 2 years' experience in bioprocess development
OR -
MS in Biological or Chemical Engineering or a related discipline AND at least 3 years' experience in bioprocess development
OR -
BS in Biological or Chemical Engineering or a related discipline AND at least 5 years' experience in bioprocess development
Preferred Qualifications:
Hands on Biotechnology industry experience. Experience with bioconjugation preferred.
Excellent problem solving & analytical skills, including data modeling, DoE, and/or statistical analysis.
Excellent teamwork, and facilitation skills.
Experience with Lab automation preferred.
Experience with GMP practices.
Demonstrated ability to communicate effectively with peers, customers, vendors, and supervisors.
Excellent ability to communicate through written reports, oral presentations, application notes, poster presentations, and similar media.
Domestic and international travel may be required.
Location:
The Senior Bioprocess Engineer is required from our Burlington, MA facility. We support a hybrid flexible work arrangement including 3 days per week onsite. Travel of up to 20% both domestic and international is required.
Pay Range for this position: $118,600 - $168,000
Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k)-matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Senior Director, CMC and Manufacturing Data & Technology
Boston, MA job
Vertex is a global biotechnology company that invests in scientific innovation. The Digital, Technology and Engineering (DTE) Research, Pre-Clinical, Manufacturing & Supply (RPMS) Group's mission is to improve the lives of patients through data, and technology innovation - with AI at the core of our transformation strategy.
Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission and enable Vertex to grow in scale; ensuring we remain on the forefront of science, medicine and technology.
The Senior Director, CMC and Manufacturing Data & Technology will define, lead and execute the vision for how Vertex will revolutionize our global pharmaceutical science and manufacturing activities through AI, data science and technology solutions. You will champion the adoption of AI-driven approaches to optimize manufacturing operations, drive predictive analytics, enable intelligent automation across pharmaceutical development, clinical and commercial manufacture based upon a foundation of robust transactional systems to plan, track and action in internal and external manufacturing facilities.
Working with multiple Vertex business units, the Senior Director is accountable for the end-to-end manufacturing experience worldwide, across a broad range of internal and external pharmaceutical development and manufacturing teams powering both clinical and commercial supply.
The role is a critical part of the Data Technology & Engineering leadership community. The Senior Director will bring their multi-disciplinary expertise to orchestrate innovation with leaders across science, manufacturing, data science and technology, including core disciplines in infrastructure, data and software engineering, data science, architecture, portfolio and security, to ensure coordination as all R&D and Manufacturing environments transform through smart, scalable solutions.
Reporting directly to the VP RPMS, the dynamic and experienced Senior Director, CMC and Manufacturing Data & Technology will play a key role on the RPMS Leadership Team to drive our digital transformation initiatives across Research, Pre-clinical, Manufacturing and Supply Chain.
Key Duties and Responsibilities:
Vision and Strategy
* Develops, articulates, and executes a clear vision for delivering AI-powered technology solutions for CMC and manufacturing worldwide, internally and externally, across multiple business units, in alignment with Vertex's strategic goals.
* Influences a broad internal and external landscape to cultivate a roadmap of opportunities to transform pharmaceutical development and manufacturing activities through cutting-edge AI technologies including generative and agentic AI, machine learning and data driven automation.
* Leads with agility to think strategically about scientific, engineering, business, product, and technical challenges simultaneously.
* Collaborates as a trusted partner to the research and manufacturing leadership to ensure technology strategies robustly accelerate portfolio and commercial goals and as key enablers of operational excellence.
Operational Execution
* Specializes in driving transformative strategies that foster innovation, elevate organizational performance and drive growth.
* Leads in the identification of opportunities for innovation in delivery, evaluation of state-of-the-art AI (including generative AI and agentic AI), data product, data science, external and internal integrations, software, hardware and protocols, applicability and risks.
* Combines creativity, practicality and integrity to ensure technology solutions that are strategic, flexible, scalable, reusable and are achieved through the application of Vertex's architectural principles, standards and governance.
* Leads with rigor and discipline maximizing fiscal, resource and operational effectiveness.
* Manages an effective and efficient technology operation that enhances manufacturing at Vertex, ensuring stakeholders can depend on technology as a robust enabler of drug research and production whilst maximizing ROI.
* Partners effectively with suppliers ensuring effective delivery aligned to Vertex's high expectations in compliance, quality and security.
Leadership
* Leads and develops a high-performing, diverse team of professionals, fostering a culture of innovation, collaboration, and accountability.
* Creates a culture of inclusion, diversity, and equity where everyone can do their best work and feels valued.
* Aligns the CMC and manufacturing technology team with enterprise priorities, ensuring data strategies drive business outcomes and regulatory compliance.
* Represent the CMC and manufacturing technology technology organization in internal and external forums, advocating for its ability to achieve strategic goals and for innovation leadership.
Required Education and Experience:
* Bachelor's degree in science, engineering, computer science or a related field or relevant experience
* 10+ years of experience in life sciences technology or related fields.
* Relevant experience in creating and applying technologies to solve computationally intensive and data intensive problems in manufacturing, inclusive of 5+ years in a leadership role.
Required Knowledge and Skills
* Extensive knowledge of large-scale scientific and manufacturing environments to effectively understand user needs.
* Extensive technical knowledge and experience across broad range of complex scientific and manufacturing technology.
* Extensive experience in applying AI and machine learning to solve complex, data intensive problems in global manufacturing environments.
* Extensive experience in core foundational manufacturing operations technology including electronic batch records, process control, execution systems, quality and exception systems.
* Strength and depth in leading and overseeing operations technical support for a manufacturing environment.
* Experience with varied compute environments including distributed, cloud and high performance computing.
* Experience of successfully developing and implementing technology strategy; preferably within a complex pharmaceutical manufacturing organization.
* Expertise in successful development and delivery of multiple complex scientific and manufacturing technology development initiatives.
* Strong leadership and team-building skills, with demonstrated success in managing diverse teams and fostering high engagement.
* Excellent communication skills including the ability to produce strategic documents, present ideas and solutions to technical and non-technical audiences and all levels of the organization.
* A strong commitment to compliance and integrity in systems, processes, and actions, with a deep understanding of the biotech regulatory environment.
* Exceptional problem-solving and strategic thinking abilities, with a focus on driving innovation and operational excellence.
Other Requirements
* Experience with enabling advanced technologies, such as AI and machine learning, through data engineering strategies is highly desirable.
* Advanced certifications in product, agile, software engineering, cloud technologies, or leadership.
#LI-Hybrid
Pay Range:
$236,000 - $354,000
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.
#LI-Hybrid
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
Auto-ApplyDirector, Global Process Excellence, Finance Systems and Reporting
Boston, MA job
The Director, Global Process Excellence, Finance Systems and Reporting is a key member of the Vertex Global Finance organization and will be leading continuous improvement workstreams including projects aimed at improvement of Global Finance processes, implementation and enhancement of finance systems and support of enterprise reporting capabilities.
Reporting to the VP, Global Process Excellence, Finance Systems and Reporting, this role is a key leader in ensuring that Vertex's global R&D/BSMO finance teams can scale efficiently to meet the needs of an increasingly large and complex pipeline by optimizing global processes, implementing and enhancing finance systems and building new scalable global capabilities to enable efficient and effective enterprise planning and reporting. An important aspect of this role is the ability to have influence without authority, and to be able to maintain an enterprise-wide view where global processes and solutions are most effective and efficient for Vertex.
Success in this role requires a deep understanding of Vertex's business and strategy including a strong understanding of R&D, BSMO and PPM processes, experience in designing and implementing global processes and finance systems, an ability to lead and manage change and to collaborate effectively within Finance and with other key stakeholders (Accounting, Internal Audit, DTE, PPM, HR etc.) to ensure strategic and operational alignment. Collaboration and strong partnership with R&D Finance, BSMO Finance (including cost accounting) and the PPM organization is paramount to success in this role.
In addition, success will include an ability to lead and support process improvement projects. This includes partnering with project owners to plan and execute workshops, as well as help to create documentation where needed, and project manage follow ups and implementation when needed. Finally, this role will help develop continuous improvement skills within our global finance team, providing coaching, sharing tools and promulgating best practices.
Key Duties & Responsibilities
* Strategizes with finance and business leaders to identify and prioritize global R&D Finance process optimization opportunities to enable Vertex's efficient growth through industry-leading cross-functional innovation and business partnering.
* Partners with Finance leadership to develop a strategy for that organization's efficient scaling on short term processes as well as the LRP.
* Leads process and systems enhancement workstreams to help optimize the use of data driven insights to drive integrated enterprise decision making.
* Enables VRTX growth by using data and technology platforms to enable operating efficiencies, growth and ability to scale with sustainable, compliant and risk balanced processes.
* Drives implementation of VRTX global financial data structures to ensure that we are organizing and governing data to enable effective performance management and decision support as Vertex grows in scale and complexity.
* Partners closely with Finance, PPM, HR, Accounting and DTE to ensure that Vertex is building integrated enterprise planning capabilities to enable short- and long-term decision making and resource allocation.
* Collaborates and communicates effectively with others, identifies opportunities where change management is needed and helps to develop plans of action to address the gaps.
* Helps to develop and coach more junior team members to encourage growth and new opportunities and maintaining an atmosphere of inclusivity across the team.
* Utilizes data analytics and metrics to identify trends, make recommendations and mitigate resourcing and financial risks.
Basic Requirements:
* Bachelor's degree in business, Finance or Accounting.
* MBA and CPA a plus.
* Typically requires 12+ years of relevant experience in a finance managerial role demonstrating strong technical and analytical skills, and a track record of success working in a team-based environment or the equivalent combination of education and experience.
Preferred Knowledge/Skills:
* Possesses a continuous improvement mindset, constantly interrogating the way we operate with flexibility and ability to drive change.
* Significant experience leveraging Lean and Six Sigma concepts to identify opportunities for improvement and to develop and implement action plans.
* Experience partnering with cross-functional teams and processes; able to manage through ambiguity and influence with and without authority.
* Must have vision for the future, an ability to think strategically on getting alignment across various groups, and an ability to partner effectively with R&D and BSMO Finance leadership.
* Ability to find innovative solutions to complex problems, leveraging industry best practices and finding solutions that are fit-for-purpose for Vertex but also contemplate future business needs.
* Ability to effectively work with and influence senior leaders including the DTE LT, FLT, HR LT and PPM LT individually and in gaining alignment amongst these groups when needed.
* Strong interpersonal, written, and verbal communication skills.
* Significant knowledge of drug development process with strong business acumen and judgment; knowledge of the company's markets/products a plus.
* Strong project management ability and ability to manage multiple projects and areas of ownership.
* Proactive, organized, and comfortable managing shifting priorities in a rapidly changing environment.
#LI-DB1
#HYBRID
Pay Range:
$180,800 - $271,100
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.
#LI-Hybrid
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
Auto-ApplyDirector, Environmental Health & Safety
Bedford, MA job
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The Director of EHS is a senior leader responsible for shaping and driving Sarepta's global EHS strategy. Reporting to the Vice President of Facilities, Engineering, and Capital Assets, this role will serve as the principal authority on EHS policies, compliance, and risk management across all sites. The Director will lead the development and execution of a comprehensive EHS management system, ensuring alignment with business objectives and regulatory requirements.
This position will oversee a growing team of EHS professionals and will be accountable for building organizational capability, fostering a proactive safety culture, and positioning EHS as a strategic partner in business decision-making.
The Opportunity to Make a Difference
Strategic Leadership: Define and implement a forward-looking EHS vision, strategy, and roadmap that supports Sarepta's business growth and operational excellence.
Executive Partnership: Act as a trusted advisor to senior leadership, influencing risk-based decisions and integrating EHS considerations into corporate strategy.
Program Development: Establish and maintain a robust EHS management system, ensuring compliance with all applicable laws, regulations, and industry best practices.
Team Building: Recruit, develop, and lead a high-performing EHS team, fostering a culture of accountability, innovation, and continuous improvement.
Risk Management: Oversee programs for occupational safety, industrial hygiene, environmental compliance, sustainability, and emergency preparedness.
Incident Command: Serve as Incident Commander during emergency response and recovery efforts; provide technical expertise for crisis management.
Enterprise Oversight: Direct EHS operations across Massachusetts and Ohio sites, with additional support for other business entities as needed.
More about You
Bachelors degree required, Master's degree in Industrial Hygiene, Occupational Safety, Environmental Science, or related field preferred.
Minimum 12-15 years of progressive EHS leadership experience, including at least 5 years in a senior management role within biopharmaceutical or chemical research environments.
Professional certifications strongly preferred: CIH, CSP, or CHMM.
Deep knowledge of OSHA, NFPA, EPA, and other federal, state, and local regulations.
Proven success in implementing enterprise-level EHS systems and programs, including emergency response, hazardous materials management, biosafety, and sustainability initiatives.
Exceptional communication and influencing skills, with the ability to engage stakeholders at all levels.
Recognized for leadership qualities aligned with Sarepta's core values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Onsite#LI-CM1This position requires work on site at one of Sarepta's facilities in the United States.The targeted salary range for this position is $180,000 - $225,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Auto-ApplyAssociate Director, Global Medical Information and Review
Cambridge, MA job
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The responsible individual will play a critical role in supporting, leading and development of the department of Medical Information & Review within the Medical Affairs function reporting to the Head of Global Medical Information & Review. This individual will work closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, PV, Medical Affairs and Clinical Development to assure that all materials, both promotional and medical, meet the rigorous standards of scientific accuracy, objectivity, and fair balance. This person will also serve on cross functional teams, representing medical affairs.
The Opportunity to Make a Difference
Develop and implement global medical information strategies aligned with biotech innovation and patient-centric values.
Create and maintain scientifically rigorous Standard Response documents based on emerging data and publications.
Manage external vendors and call center operations to ensure high-quality, timely responses to inquiries from healthcare professionals and patients
Serve as a key member of MRC & PRC review committees
Provide timely, medically relevant, scientifically sound, and fair-balanced medical/scientific reviews of materials submitted to medical and promotional reviews
Responsible for providing oversight of the review of promotional and medical materials for scientific/medical validity across Sarepta's Portfolio.
Represent medical affairs in global cross-functional team meetings
Critically review and provide solutions to complex promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities in accordance to scientific communication and with relevant guidance across Sarepta.
Proactively cultivate and grow strong relationships with cross-functional leads and other stakeholders to provide medical guidance in the development of scientific materials and resolve issues or concerns in promotional and medical review
Leverage defined metrics and other tools to improve team performance and ensure adequate resource allocation
Determine acceptability of data/references used to support promotional claims and provide expert guidance as well as effective negotiation leading to resolution for approval of pieces
Address any scientific decision support needs from inquiries coming into Sarepta.
Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines
Participate in the creation of, and ensure adherence to, departmental and corporate policies and SOPs and constantly look for places where process improvements would enhance the workflow
Support commercial planning and launch planning activities including training materials, and medical information to provide scientific and medical support for publications and presentations
Monitor the medical literature for Sarepta product(s) and relevant competitor data; analyzes the information for accuracy and relevance and appropriately synthesizes the data for inclusion in materials under review.
Collaborate with commercial operations, marketing, and regulatory operations to support the creation and submission of marketing materials and documentation to regulatory agencies
Collaborate with Global Medical Communications and Medical Information to align with scientific information, establishing consistent communication
Assist in driving consistency in medical information and communications, establishing one medical voice internally and externally
Participate in internal and external meetings (training, educational and others, including medical congresses) to remain current on ever changing regulations, relevant new medical/scientific information and commercial strategy
More about You
Advanced clinical/scientific degree: PharmD, PhD with 3 to 5 years of experience in medical affairs
Scientific expertise in rare disease and gene therapy a plus
Prior knowledge of the medical information and review process
Excellent interpersonal, written, and verbal communications skills are essential to establish cross functional relationships.
High degree of accuracy; eye for detail, fastidious
Ability to effectively manage time while balancing numerous high priority projects with a sense of urgency
Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required
Self-motivated with exceptional follow through
Demonstrates flexibility in response to changing needs and competing demands
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid#LI-CM1This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Auto-ApplyResearch Associate/Engineer I, Technical Development (2026 Rotation Program)
Norwood, MA job
The Role
is located in Norwood, MA and has a start date of August 3, 2026.
The Technical Development organization at Moderna is looking for top talent in science and engineering to deliver on its mission to design manufacturing processes for mRNA medicines. This posting is for a full-time position in Moderna's Technical Development Rotation Program. Rotation Program participants will have an exciting opportunity to explore different areas of mRNA therapeutic development through completing three 6-month rotations in Technical Development. Participants will be part of high-performing project teams developing new manufacturing platforms to produce mRNA therapeutics and vaccines destined for clinical trials and commercial licensure. You will apply your educational background and learn new technical skills in the synthesis of mRNA, assembly of lipid nanoparticles, and formulation of drug products. Through completing an operational rotation, you will develop a deep understanding of how Technical Development's efforts enable the manufacture of mRNA medicines. Technical Development is based in Norwood, MA.
Here's What You'll Do
Work with a team of highly skilled experts to come up to speed on technology and techniques.
Use laboratory, technical and communication skills to generate experimental results, perform data analysis, and document in formal reports including conclusions and recommended next steps.
Perform process scale-up, support technology transfer and provide manufacturing support at internal Moderna, and external contract manufacturing sites.
Participate in planning, design, execution, analysis of experiments and formal risk assessments to establish critical process parameters, and overall process control strategies.
Optimize the impact of formulation and processing conditions on the stability of mRNA drug products and process intermediates.
Review and share relevant academic literature and establish new collaborations with internal research and manufacturing groups.
Create scaled-down models, and high throughput experimental setups for unit operations.
Characterize mRNA and lipid nanoparticles through collaboration with the analytical team.
Prepare technical reports and present finding in cross-functional meetings.
Additional duties as may be assigned from time to time.
Here's What You'll Need (Basic Qualifications)
Bachelors or Masters Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biomolecular Engineering, Chemistry, Biochemistry, Biomedical Engineering, Biophysics, Biostatistics, Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related field preferred.
Strong fundamental scientific and engineering skills for the evaluation of experimental data
Laboratory skills applicable to bioprocess development and analytical methods
At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
Here's What You'll Bring to the Table (Preferred Qualifications)
GPA of 3.5 on a 4 scale or equivalent
Demonstrated ability to work both independently as well as the ability to contribute to high performing teams.
Excellent written and verbal communication skills.
Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (GxP, GMP, GLP)
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $63,200.00 - $100,900.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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Auto-ApplySenior Manager, Finance - Inventory & Manufacturing Operations
Bedford, MA job
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
* Physical and Emotional Wellness
* Financial Wellness
* Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The Senior Manager of Finance - Inventory and Manufacturing Operations will be responsible for managing the execution of processes aimed at delivering performance-based analytics within the Technical Operations organization. Key duties include managing the product costing process to support strategic business planning, standard costing, and the annual business planning cycle. Collaborating closely with FP&A and the Director of Inventory and Manufacturing, this role will drive the creation and deployment of a financial analytical framework for the Technical Operations Organization. Additionally, this position will supervise a costing group and oversee all financial aspects related to inventory and manufacturing operations for both commercial and clinical programs, including cost accounting. This position will also manage financial accounting processes, policies, procedures, and internal controls within these areas, working closely with Technical Operations and FP&A team members to assist in forecasting and budgeting. The position will also be tasked with managing the accounting related to these areas and the financial reporting.
The Opportunity to Make a Difference
* Developing a strong business partner relationship with the Manufacturing, QA, QC, and Process Development functions.
* Managing a financial performance management platform for the Technical Operations Organization
* Manage Inventory and Manufacturing Finance Costing Team.
* Manage and complete the monthly accounting close process related to inventory, manufacturing, and clinical trials, ensure compliance with U.S. GAAP.
* Analyze and validate all inventory transactions in Oracle.
* Develop, implement, and maintain a standard cost accounting process for our manufacturing operation, including performing periodic cost studies in support of our standard cost model and the regular investigation, resolution and reporting of actual-to-standard variances.
* Work directly with Third Party vendors to ensure accurate monthly reports.
* Develop and maintain inventory cycle counting process.
* Provide business analysis, forecasting and budgeting with the Technical Operations organization in partnership with our FP&A group, including making recommendations for financial and operational improvements.
* Maintain and make recommendations to improve our system of internal accounting controls as they relate to inventory and manufacturing.
* Work within our existing Oracle ERP system and the Oracle Process Manufacturing module, lead efforts to recommend and implement any expansions of this system.
* Manage the preparation of the internal and external reporting related to these key areas, including internal monthly reporting and quarterly reporting to be filed with the SEC and assist in the external audit functions.
* Develop monthly inventory reports for Finance leadership and business partners to support analytics and strategic decision making.
* Develop monthly flux analytics to support SEC filings.
More about You
* Bachelor's and/or master's degree in accounting/finance or similar.
* Seven to Nine years' experience in manufacturing, inventory/finance positions of growing responsibilities
* Requires a strong working knowledge of Oracle OPM Financials module.
* Solid understanding of manufacturing operations, inventory, and cost accounting.
* Understanding of U.S. GAAP as it applies to a manufacturing environment is required.
* Knowledge of accounting statements and financial reporting experience in biotechnology and/or pharmaceuticals strongly encouraged.
* Excellent analytic skills; highly proficient in Excel-based modeling with strong computer skills are also required.
* Excellent organizational and project management skills, ability to prioritize appropriately and meet deadlines.
* Strong communication and interpersonal skills, able to work effectively with personnel throughout the company as well as external vendors.
* Strong managerial skills with the ability to motivate and mentor staff.
* Strong understanding of SOX controls, design and implementation and ongoing evaluation of controls.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid
#LI-ES1
This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $132,000 - $165,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Auto-ApplyMedicinal Chemistry Research Scientist
Boston, MA job
Vertex Pharmaceuticals has an exciting opportunity for a Research Scientist in the field of medicinal chemistry. Job responsibilities include the preparation of both single and focused sets of small organic molecules, developing and optimizing synthetic methods, creating and interpreting project-relevant Structure-Activity Relationship (SAR) and problem solving. Candidates must demonstrate an expert understanding of organic reaction mechanisms, formulation of executable synthetic routes, up to date understanding of contemporary synthetic methods as well as an ability to balance rational concepts with creativity which includes the development of new synthetic methodology as needed. The successful candidate will have the ability to work independently and be able to multi-task collaboratively in teams while adapting to rapidly changing needs. A strong desire to grow as a medicinal chemist while maintaining a passion for organic chemistry and the courage to challenge conventional wisdom are essential in this role.
Key Responsibilities
* Maintain a high level of productivity in the laboratory setting
* Develops and executes clear synthetic routes using state-of-the-art synthetic methodologies
* Primarily responsible for executing organic syntheses in a timely, efficient, and independent manner
* Create and interpret SAR with a clear understanding of the biological data
* Organize and triage efforts to stay consistent with project priorities
* Clearly and effectively communicate ideas and results (both verbally and in writing) to a broad range of audiences
Knowledge And Skills
* Designs and executes complex, challenging chemistry experiments
* Demonstrates astute understanding of his/her own discipline and the relevant literature
* Maintains a high level of knowledge related to current developments in the scientific project field
* Displays proven productivity and experimental creativity, and effective dissemination of ideas
* Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations
* Demonstrates awareness of other project-related disciplines and an understanding of general concepts and some experimental detail within those areas
Education And Experience
* Ph.D. (or equivalent degree) in chemistry or related science 0-3 years of relevant post-doctoral employment experience, or
* Master's degree (or equivalent degree) in chemistry or related science and 3+ years of relevant employment experience, or
* Bachelor's degree (or equivalent degree) in chemistry or related science and 6+ years of relevant employment experience
* Demonstrated effective communication skills, both verbal and written
* 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
Pay Range:
$100,000 - $150,000
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:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
#LI-Onsite
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
Auto-ApplyDirector, Project Management
Editas Medicine job in Cambridge, MA
At Editas Medicine, we are pioneering the possible. Our mission is to translate the power and potential of CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we're a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected and where you can operate at the forefront of gene editing, become an Editor!
This role is to help advance our lead
in vivo
development candidate, EDIT-401, a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates. If you are a candidate excited to help push the boundaries of what's possible in medicine, apply now.
Decoding The Role:
The Director, Project Management will lead the planning and execution of the cross-functional workstreams from pre-IND through to commercial launch. This role is responsible for leading cross functional partners in the development of a detailed program timeline in Smartsheet, clear functional budgets, and an aligned view of the program critical path. The Director, PM role will manage the weekly Program team meeting to ensure seamless cross-functional coordination of workstreams, to identify and mitigate program risks, and to successfully deliver to key program milestones (Pre-IND, IND, Phase I, II, and transition to registrational study). The ideal candidate will bring deep experience in clinical trial operations and project management within biotech or pharmaceutical settings, particularly in gene therapy programs.
This position will operate in a highly matrixed, fast-paced biotech environment from Editas's Cambridge, MA headquarters. An ideal candidate demonstrates:
Strong communication skills: this candidate is able to effectively partner with internal and external stakeholders across the team. This candidate balances inquiry with advocacy when engaging with teammates to ensure he/she fully understands a situation before engaging in problem solving.
Organizational skills: this candidate is a detailed oriented planner, diligently confirming and aligning the functional plans of her / his peers. This candidate has a track record of establishing program structure; he / she enables a logical, process-driven approach to enhance collaboration across teams.
Teamwork and leadership: This candidate possesses a highly collaborative mindset and is skilled at productive debate that builds team commitment to a recommended path forward. This candidate tests functional thinking and respectfully challenges his/her teammates to get to reasonable program assumptions.
Adaptability: This candidate has demonstrated the ability to balance multiple priorities and adapt their approach to be successful in a fast paced, dynamic biotech environment.
Characterizing Your Impact:
As the Director, Program Management , you will:
Lead the operational planning and execution of the cross-functional program plan; establish and reinforce a Program structure that enables cross-functional collaboration
Develop detailed project plans including timelines, milestones, interdependencies, budgets, and the Program Team critical path
Coordinate activities and deliverables across functional teams including Clinical, Non-clinical, Regulatory, CMC, and Data Management.
Track progress against plans, identify risks, and implement mitigation strategies.
Provide regular updates to leadership and governance committees.
Requirements
The Ideal Transcript:
To thrive in this role, you'll need:
A minimum of a bachelor's degree in life sciences or related subjects; advanced degrees (MBA) are desirable.
8-10 years of experience in biotech/pharma, with 3-5 years in program management supporting early-stage clinical development. Experience managing multiple programs at the same time is desirable.
Proven track record of leading cross-functional teams in a matrixed environment.
Strong understanding of preclinical development, IND-enabling studies, and early clinical trial operations. Experience across functional roles is desirable.
Experience with gene therapy or gene therapy programs is highly desirable.
Mastery of project management tools and methodologies, including Smartsheet, Microsoft Project, and OnePager
Benefits
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
$210,000 - $230,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor?
We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
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