Director, Commercial Master Data Management
Alkermes job in Waltham, MA
Director - Commercial Master Data Management
The Director, Commercial Master Data Management will be responsible for establishing key Master Data assets (including Customer) as trusted sources of truth and ensuring appropriate use of Master Data by the Commercial organization. This position will define and lead Master Data Management (MDM) strategy, MDM governance, MDM capability development / enhancement, MDM operations, and Master Data integration with other data and systems in the Commercial infrastructure. This position will play a key role in the Data, Analytics & Insights organization reporting to the Head of Commercial Data Management and will lead a team of internal and external data stewards and MDM system analysts and developers. The ideal candidate should have extensive knowledge in Pharma Commercial MDM solutions and Customer/Payer/Product Master Data, understand downstream business impact, and have the ability to advocate, adopt, and lead the implementation of best practices to optimize our Master Data as business strategy and technology evolve. This role will be based in Waltham, MA with a weekly hybrid office schedule.
Basic Qualifications
EDUCATION AND EXPERIENCE:
Bachelor's degree required, post-graduate degree preferred; Major in Mathematics, Computer Science, Business Analytics, Business Management, Information Management, Operations Research, or related subject
Extensive knowledge of pharma commercial MDM, cloud-based solutions (Informatica, Reltio, and/or Veeva), and downstream business impact required
Experience leading internal and external teams of data stewards and system analysts required
Business and technical fluency in CRM, Data Warehouse, SQL, Excel, and PowerPoint required.
10-12 years' experience with 4-6+ years' supervisory experience in MDM within a commercial organization in the pharmaceutical/biotech industry with proven business results strongly preferred
Hands-on experience with multiple data technologies and processes such as data management, data architecture, data integration, data quality, and metadata management strongly preferred
Experience supporting various commercial business processes in the pharmaceutical industry including Marketing, Field Operations, Analytics, Compliance, Patient Services and Market Access strongly preferred
Experience in drafting and managing data policies, SOPs, and data / process documentation in a Data Catalog preferred
Preferred Qualifications
PERSONAL ATTRIBUTES NEEDED:
Strong sense of ownership and accountability, strategic thinking, and able to make tough decisions
Excellent people and stakeholder management, and communication skills with the ability to collaborate effectively across all levels of the organization
Strong project and time management skills with the ability to understand business impact and prioritize accordingly
Able to handle ambiguity and intensity in a fast-paced environment driven by evolving business needs
Ability to work in our Waltham, MA office with a weekly hybrid office schedule
The annual base salary for this position ranges from $190,000 to $217,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: *************************************
#LI-TS1
RESPONSIBILITIES:
Functional ownership
Serve as the business owner for Commercial MDM solution and Master Data Stewardship, and provide guidance in day-to-day MDM operations
Identify and lead specific MDM projects to meet business needs, manage project timeline and deliverables, and ensure department performance goals are aligned with company objectives and achieved
Strategic Leadership
Lead the development and execution of short-term and long-term MDM strategies, including the evaluation and implementation of the optimal MDM solution, reference data sources, and operating model
Lead the development of new MDM capabilities such as Patient Mastering, and integration across commercial systems such as CRM and Commercial Data Warehouse
Maintain the MDM solution as the single source of truth for Master Data leveraged by all downstream applications, reporting, analytics, and operations
Operational Excellence
Focus on Master Data quality by developing key metrics to proactively monitor data quality and downstream business impacts, investigate and resolve ongoing and legacy data issues such as over/under merges, account affiliation and taxonomy review and cleanup
Manage and triage ad-hoc business requests, oversee the resolution of field submitted data change requests (DCRs) and field data inquiries
Optimize MDM processes, and lead the development of Standard Operating Procedures (SOP)
Cross-functional Collaboration
Collaborate and manage stakeholders across Data, Analytics & Insights, Commercial Operations, Market Access, Sales, Marketing, IT, and external data management services providers.
Lead cross-functional discussions to understand and document business requirements for Master Data; communicate and set clear expectations on how appropriate solutions are identified and implemented to meet business needs
Auto-ApplyAssociate Director, Scientific Communication
Alkermes job in Waltham, MA
As a product and disease state expert within Medical Affairs, the Associate Director, Scientific Communications will provide medical, scientific and technical expertise to scientific communications deliverables for marketed and pipeline products. They will help develop, manage and track scientific communication plans as well as create and review deliverables for medical and scientific accuracy. The Associate Director will ensure compliance with Alkermes policies, procedures, and best-practices and support the development of key product materials for marketed and pipeline products.
This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
Major Accountabilities:
Act as the Medical Communications lead for product-specific working groups or projects and support Publications, as needed
Support other Scientific Communications Leads as needed in work across products
Create, manage and track strategic scientific communication plans in partnership with a cross-functional team
Create/review medical and scientific materials for both accuracy and strategic alignment for internal and external customers. Main deliverables include scientific communication platforms, MSL slide decks targeted for HCP and payor audiences, Medical Affairs booth materials, Medicaid Testimonies, and others as needed
Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information; act as a resource to others external to Medical Affairs
Partner with Medical Directors to develop and implement product specific strategy and alignment, and ensure accurate representation in scientific communication materials
Work effectively with a cross-functional team of stakeholders including Compliance, Research and Development (Clinical Development, Clinical Operations, Regulatory Affairs, Nonclinical, etc), Marketing, and individuals external to Alkermes
Ensure compliance with department and company policies and procedures
Serve as the subject matter expert for Scientific Communications review processes and the content management and review tool (Veeva Vault), provide guidance from concept/project initiation through publication
Manage vendor and budget
Support additional projects or initiatives within the Scientific Communications function
Key Performance Indicators:
Knowledge of pharmaceutical industry regulations, guidelines, standards and practices
Domestic and International travel may be required (10%)
Ability to work independently in a hybrid working model in our Waltham 3 days/week
Demonstrates problem solving skills and ability to work in a fast-paced environment with competing priorities
Exceptional interpersonal skills, experience working in a team with ability to work collaboratively toward a common goal
Excellent written and verbal communication skills and ability to read, interpret, and convey complex scientific information
Takes intelligent risk and evaluates impact of decisions
Analyzes complex situations and data, requiring evaluation of intangible and unclear factors
Employs strategic thinking to contribute to product, departmental, and organizational plans and goals
Adapts to unexpected tasks, issues, changes in strategy, or department needs and provides leadership to accomplish goals
Cultivates and maintains effective relationships across all levels of the organization as well as externally
Basic Requirements:
Advanced scientific degree preferred (MD, PhD, PharmD)
Minimum 5 years' experience in Medical Affairs, Clinical Development or related field in the industry with an MD/PhD/PharmD
Preferred Requirements:
Healthcare/scientific related degrees may be accepted
Experience in the development and review (i.e. Medical, Regulatory, and Legal review) of MSL materials and scientific platforms preferred
Experience with Veeva Vault
#LI-HB1
Auto-ApplyDirector, Customer Experience Marketer
Alkermes job in Waltham, MA
The Customer Experience Marketer is a strategic partner to the Brand Marketing team, responsible for defining the customer experience strategy and designing tactical omnichannel marketing plans across multiple audiences, including healthcare professionals (HCPs) and consumers. This role combines a deep understanding of omnichannel marketing with strong cross-functional collaboration skills to design and optimize data-driven, insight-led customer experiences that align with brand strategy and drive business growth. This role will also be responsible for advancing omnichannel orchestration capabilities across the organization by leading cross-functional initiatives and educating stakeholders on tools and best practices.
Alkermes has adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home.
Minimum Education & Experience Requirements:
Bachelor's degree required; advanced degree preferred (e.g., in Marketing, Analytics, Information Systems, or related fields)
12+ years of professional marketing or related experience
Preferred Skills and Knowledge Qualifications:
Solid understanding of regulatory and compliance related concepts that govern biopharmaceutical commercial activities, or similar experience from other regulated industries
Experience with marketing in complex, multi-stakeholder environments (B2B, account-based, etc.)
Familiarity with pharmaceutical industry best practices and evolving trends in omnichannel customer experience
Travel Requirements:
Overnight travel
#LI-TT1 #LI-hybrid
Key Responsibilities:
Establish trust and credibility with Brand Marketing as a data-driven customer experience expert that aligns customer experience strategy with brand goals
Translate customer insights into actionable engagement strategies and channel-mix recommendations that maximize impact
Collaboratively design customer experience maps for customer segments that align the right content with the right channels based on customer needs and brand strategies
Develop detailed cross-channel tactical marketing plans including campaign design, business rules, measurement strategy, and metadata requirements to support analytics
Collaborate with stakeholders across Marketing, Data Analytics & Insights, Sales, and partners (agencies, media, third party program partners, etc.) to drive aligned channel execution
Define success measures for omnichannel campaigns and monitor performance against objectives while in-flight and retrospectively
Partner with Data Analytics & Insights to evaluate business impact, uncover insights, drive continuous optimization, and inform ongoing customer experience refinement
Advance the evolution of cross-brand omnichannel orchestration capabilities by identifying new opportunities, leading cross-functional working groups, and driving adoption
Educate and enable brand teams and other stakeholders on omnichannel capabilities, engagement frameworks, and best practices
Capture and document best practices to foster knowledge sharing and continuous improvement in omnichannel customer experience
Skills & Abilities:
Strong organizational skills with the ability to work on multiple projects simultaneously
Demonstrated ability to lead, advocate, influence, and collaborate across various functions, levels, and external partners
Strong business acumen, with a working knowledge of data, technology, marketing, and commercial strategy
Excellent communication, presentation, and interpersonal skills with the ability to simplify complex concepts for diverse audiences
Auto-ApplySenior Analyst, Digital Marketing Analytics (Hybrid)
Alkermes job in Waltham, MA or remote
The role is a key member of the Sales & Marketing Analytics team, responsible for providing analytical support and transforming digital marketing data into actionable insights for a growing commercial organization. This role collaborates with internal stakeholders and external vendors to extract meaningful insights from data for Brand Marketing team and Customer Experience Marketing team.
This role reports to the Associate Director, Sales & Marketing Analytics and work at hybrid schedule in our Waltham, MA location.
Auto-ApplySr. Medical Director/Medical Director, Global Safety Officer
Alkermes job in Waltham, MA
The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives.
Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders.
Auto-ApplyMedical Science Liaison (Psychiatry) - Northern CA
Alkermes job in Waltham, MA
Alkermes has an established Medical Science Liaison (MSL) team for CNS, with a current focus in Psychiatry. The team is responsible for creating a respected and valued presence with researchers and thought leaders working in Psychiatry. The MSLs engage in fair balanced scientific exchange with key stakeholders and respond to requests for information about Alkermes products and diseases of interest. Through a thorough understanding of national/regional experts and treatment landscapes, the MSL will gain insight into emerging trends. These insights will help shape medical strategy.
Doctoral level preferred in Pharmacy, Medicine, Biological Sciences, Health Services Research, Nursing, or Public Health (i.e., Pharm.D., M.D., Ph.D., DNP)
1-3 years' experience in pharmaceutical industry preferred; or relevant clinical/medical/research experience
Understanding of Medical Affairs and the role of the department in drug development and product commercialization
Product launch experience is a plus
CNS therapeutic area experience desired
Excellent written/verbal communication and presentation skills
Strong leadership skills and innovative attitude
Willingness to travel (approximately 65%) within assigned territory, to conferences, and the home office
Flexible to changing priorities, detail-oriented, and works well under pressure
Position will be leveled commensurate with candidate experience
The annual base salary for this position ranges from $180k to $190k. In addition, this position offers a performance-based bonus target and eligibility to participate in our long term incentive program. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: *************************************
#LI-MB1 #LI-Remote
Identify, establish, and maintain clinical and scientific relationships with Key Thought Leaders (KTLs) and Developing Thought Leaders (DTLs), including physicians, NPs, pharmacists and researchers
Act as vital conduit to investigators and key organizations interested in developing research collaborations with Alkermes
Engage with clinical investigators in support of Alkermes sponsored studies as appropriate
Attend and provide Medical Affairs support at scientific conferences
Support internal stakeholders by providing subject matter expertise
Respond, as appropriate, to unsolicited requests for medical/scientific information
Provide clinical presentations and educational information in academic, community and healthcare provider settings
Share insights from the field with appropriate internal colleagues
Adhere to all Alkermes policies and procedures
Auto-ApplyLegal Externship - Spring 2026
Burlington, MA job
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.
Are you a motivated law student with a keen interest in the pharmaceutical industry and a desire to gain practical legal experience in a sector that directly impacts patient care, science, and innovation? MannKind Corporation invites you to join our legal team as a Legal Extern. This externship provides an exceptional opportunity for 2L or 3L law students to gain exposure to a broad range of legal practice areas, develop writing skills, and gain exposure to various legal areas relevant to the pharmaceutical sector.
Legal Externship Overview
As a Legal Extern at MannKind, you will have the opportunity to work closely with experienced attorneys and gain hands-on experience in a variety of legal areas within the pharmaceutical industry. You will conduct legal research and advise business partners in employment law, commercial, research agreements, corporate matters, regulatory compliance, and other areas as needed. You will work in a fast-paced environment that offers a unique blend of legal and business challenges.
Key Responsibilities:
* Conduct legal research and analysis in emerging legal areas relevant to the pharmaceutical industry.
* Assist in drafting and reviewing legal documents, including contracts, and agreements.
* Develop writing skills by preparing legal memoranda, briefs, and other documents for internal and external stakeholders.
* Update and create new policies and procedures with an opportunity to roll out and implement throughout the organization.
* Support the legal team in various projects and initiatives, including compliance efforts and risk management activities.
* Collaborate with cross-functional teams to address legal issues and provide legal guidance as needed.
Qualifications:
* Currently enrolled in a Juris Doctor (JD) program and in good academic standing.
* Completion of at least two years of law school (2L or 3L).
* Strong research, analytical, and writing skills.
* Interest in the pharmaceutical industry and willingness to learn about legal issues specific to this sector.
* Ability to work independently and collaboratively in a fast-paced environment.
Benefits:
* Hands-on experience in legal within a dynamic pharmaceutical environment.
* Mentorship from experienced professionals in the field.
* Opportunity to contribute to meaningful projects that have the potential to impact patient care.
* Competitive compensation package.
Schedule and Location:
* Full-time commitment (40 hrs.), Monday to Friday
* Work Location: Hybrid (Burlington, MA)
Duration and Compensation:
* This is a paid externship position.
* Duration: January 12 through April 24, 2026 (Spring Term)
Intern - Analytical
Waltham, MA job
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview Snapdragon Chemistry is currently seeking exceptional candidates to Intern in our analytical sciences team.
A successful candidate will be joining a group of innovative and entrepreneurial scientists, with broad deliverables including the design of synthetic routes amenable to continuous flow processing, the development of reactor systems incorporating cutting-edge flow technology, and delivering intermediates, APIs and high value specialty chemicals to our clients.
We are looking for a candidate who has a passion for learning and working in a fast-paced, dynamic environment.
The ideal candidate will be pursuing a bachelors or master's degree to be completed by 2028.
The candidate should have experience in a wet chemistry lab, direct experience operating analytical HPLC, GC, or LCMS equipment is a plus.
Candidates must possess strong written and oral communication skills.
Responsibilities Leverage scientific knowledge and develop technology to solve analytical challenges in pharmaceutical process development.
Contribute to day-to-day analytical laboratory operations and assist in method setup and equipment troubleshooting.
Contribute to activities that build upon Snapdragon Chemistry's proprietary knowledge and technology fulfill their value creation potential.
Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders.
Ensure up-to-date knowledge of continuous flow technology, process analytical technologies and process development principles.
Ensure that the integrity and profile of Snapdragon Qualifications/Skills Leverage scientific knowledge and develop technology to solve analytical challenges in pharmaceutical process development.
Contribute to day-to-day analytical laboratory operations and assist in method setup and equipment troubleshooting.
Contribute to activities that build upon Snapdragon Chemistry's proprietary knowledge and technology fulfill their value creation potential.
Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders.
Ensure up-to-date knowledge of continuous flow technology, process analytical technologies and process development principles.
Ensure that the integrity and profile of Snapdragon Education, Experience & Licensing Requirements Actively pursuing a BS or MS in Chemistry, Chemical Engineering, or related field The estimated hourly rate of $20.
00/hr - $26.
00/hr reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, and certifications or other professional licenses held.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
Actively pursuing a BS or MS in Chemistry, Chemical Engineering, or related field Leverage scientific knowledge and develop technology to solve analytical challenges in pharmaceutical process development.
Contribute to day-to-day analytical laboratory operations and assist in method setup and equipment troubleshooting.
Contribute to activities that build upon Snapdragon Chemistry's proprietary knowledge and technology fulfill their value creation potential.
Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders.
Ensure up-to-date knowledge of continuous flow technology, process analytical technologies and process development principles.
Ensure that the integrity and profile of Snapdragon
Auto-ApplyDirector, Customer Experience Marketer
Alkermes job in Waltham, MA
The Customer Experience Marketer is a strategic partner to the Brand Marketing team, responsible for defining the customer experience strategy and designing tactical omnichannel marketing plans across multiple audiences, including healthcare professionals (HCPs) and consumers. This role combines a deep understanding of omnichannel marketing with strong cross-functional collaboration skills to design and optimize data-driven, insight-led customer experiences that align with brand strategy and drive business growth. This role will also be responsible for advancing omnichannel orchestration capabilities across the organization by leading cross-functional initiatives and educating stakeholders on tools and best practices.
Alkermes has adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home.
Auto-ApplyProcess R&D Co-Op
Waltham, MA job
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview Snapdragon Chemistry is currently seeking exceptional candidates to work as a co-op within our process R&D team.
A successful candidate will be joining a group of innovative and entrepreneurial scientists, with broad deliverables including the design of synthetic routes amenable to continuous flow processing, the development of reactor systems incorporating cutting-edge flow technology, and delivering intermediates, APIs and high value specialty chemicals to our clients.
We are looking for a candidate who has a passion for learning and working in a fast-paced, dynamic environment.
The ideal candidate will be pursuing a bachelors or master's degree to be completed by 2028.
Candidates must possess strong written and oral communication skills.
Responsibilities Leverage scientific knowledge and develop technology to solve analytical challenges in pharmaceutical process development.
Contribute to day-to-day analytical laboratory operations and assist in method setup and equipment troubleshooting.
Contribute to activities that build upon Snapdragon Chemistry's proprietary knowledge and technology fulfill their value creation potential.
Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders.
Ensure up-to-date knowledge of continuous flow technology, process analytical technologies and process development principles.
Ensure that the integrity and profile of Snapdragon Qualifications/Skills Leverage scientific knowledge and develop technology to solve analytical challenges in pharmaceutical process development.
Contribute to day-to-day analytical laboratory operations and assist in method setup and equipment troubleshooting.
Contribute to activities that build upon Snapdragon Chemistry's proprietary knowledge and technology fulfill their value creation potential.
Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders.
Ensure up-to-date knowledge of continuous flow technology, process analytical technologies and process development principles.
Ensure that the integrity and profile of Snapdragon Education, Experience & Licensing Requirements Actively pursuing a BS or MS in Chemistry, Chemical Engineering, or related field The estimated hourly rate of $20.
00/hr - $26.
00/hr reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, and certifications or other professional licenses held.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
Actively pursuing a BS or MS in Chemistry, Chemical Engineering, or related field Leverage scientific knowledge and develop technology to solve analytical challenges in pharmaceutical process development.
Contribute to day-to-day analytical laboratory operations and assist in method setup and equipment troubleshooting.
Contribute to activities that build upon Snapdragon Chemistry's proprietary knowledge and technology fulfill their value creation potential.
Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders.
Ensure up-to-date knowledge of continuous flow technology, process analytical technologies and process development principles.
Ensure that the integrity and profile of Snapdragon
Auto-ApplyDirector, IT R&D Systems
Alkermes job in Waltham, MA
This individual will manage all technology implementation, production support and maintenance activities for the Clinical, Regulatory and Medical Affairs business units. The successful candidate will manage budget, scope and resources, and will have subject matter expertise in the processes, procedures and content of managing IT delivery for Clinical, Regulatory, Medical Affairs, and Drug Safety Pharmacovigilance (DSPV) business units in a pharmaceutical organization.
This role is based at Alkermes' Waltham, MA location with a hybrid office schedule.
Auto-ApplyAssociate Director, Biostatistics
Bedford, MA job
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Job Summary: The Associate Director of Biostatistics will be responsible for oversight and input on statistical design, data analysis, and regulatory interactions for all MannKind programs. The ideal candidate combines deep technical expertise with collaborative leadership and brings a strong track record of supporting clinical development. This position will act as the leading statistician on multiple studies/projects across different therapeutic areas. This is a unique opportunity for a biostatistics leader who's looking to make a significant impact in a fast-moving, high-growth environment.
Responsibilities:
Provide input to protocol and study design, Statistical sections and study objectives, adaptive designs, endpoints, estimands, sample size computation and power estimations
Development of Randomization Plans, including generation of mock and final randomization lists. Collaborate with team re: implementation of specifications for randomization system set up
Participate in the development of Bioanalytical Plans, PK Analysis Plans and PK Data Transfer Agreements
Provide key input to project DSMB Charters, Blinding and Unblinding Plans, Statistical Analysis Plans, and study drug compliance calculations
Review of protocol deviations in conjunction with populations assignments; review TLF and shells; review and approval of CSRs; review and approval of overall submission packages (SDTM and ADaM datasets)
Work with Statistical Programmer to develop specifications for datasets in conjunction with the SAP and submission package
Review of key results and statistical assessment in preparation of publications and regulatory submissions (IBs, Protocols, Clinical Summaries, IRs, Briefing Documents, DSURs, Integrated Safety and Efficacy Summaries, etc.). Attend prep meetings and participate in Agency meetings as requested
Provide statistical expertise in development of MannKind data collection standards
Provide input into annual budget estimations
Manage CRO and contract statisticians
Attend project and study team meetings as needed. Support and participate in activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected
Provide statistical expertise by identifying potential issues, providing recommendations and bring in external statistical experts for relevant issues as needed
Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP), and industry standards in statistical analysis and reporting
Qualifications:
Master's Degree PhD or MS in Statistics, Biostatistics or other Scientific discipline
Minimum of 10 years of experience in statistical analysis for clinical trials, preferably in the pharmaceutical or clinical research industry
Proficiency in statistical analysis software (e.g., SAS)
Experience with statistical programming and the development of TLF
Excellent communication skills, with the ability to effectively communicate statistical concepts to non-statisticians
Strong collaboration skills with cross-functional teams
Familiarity with regulatory requirements for clinical trial conduct and reporting
Flexible and able to support a variety of studies
Ability to act independently and with initiative
Knowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding Biostatistics
CRS Analyst I
Marlborough, MA job
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview Our Clean Room Services team is looking for both entry level and veteran Environmental Monitoring Analysts that are passionate about leveraging their talents to provide an outstanding customer experience.
If you're interested in receiving excellent training and working as part of a team of experts with opportunities for growth, you'll be a great fit in our strong company culture.
As a Cleanroom Services Analyst you will perform environmental monitoring and cleanroom qualifications within controlled environments.
You will travel to regional client sites to provide your expertise with equipment, procedures, policies and regulations to ensure that their cleanrooms meet the requirements for safe manufacturing of medical devices, pharmaceuticals and other patient products.
Responsibilities Expert use of scientific equipment while following policies and procedures Measure total air particulate, temperature, humidity and differential pressure Collect viable air and surface samples Collect purified water samples for testing Incubate media plates and enumerate any microbial growth Submit growth for microbial identification per procedure and client instruction Maintain and prepare equipment in a GMP environment.
Prepare and complete documentation (paper and electronic) per GDP.
Transport equipment and media to client sites within the New England region in company provided vehicles Familiarization with client cleanroom layouts, sampling plans and contamination control programs Sterile gowning and staging equipment and media into client cleanrooms for testing Other duties as assigned You will work with team members and under the direction of Cleanroom Services management to improve performance and client satisfaction.
Experienced Analysts will also - Perform compressed gas testing - Perform HEPA filter testing - Write risk assessments, sampling plans, investigations, protocols, reports, SOPs and other technical documents - Design and build electronic workflows - Peer review data - Assist with training - Cross-train to support other business functions, which may include: Validations, Metrology, Microbiology, Quality Assurance, Sales Support and Leadership Qualifications/Skills Ability to read, analyze, interpret, and follow standard operating procedures, technical procedures, professional journals and governmental regulations to provide advantage to Cambrex opportunities.
Mathematical skills including the ability to analyze scientific and test data, and a basic understanding of statistical analysis.
Ability to effectively present information to internal and external audiences.
Ability to write reports and business correspondences Actively participate in team and company meetings.
Excellent interpersonal skills, with ability to interact effectively and work efficiently with customers, partners and colleagues at all levels in an organization.
Excellent communication skills: verbal, written and active listening.
Education, Experience & Licensing Requirements Entry Level Qualifications Associate's degree in Microbiology or related field with a minimum of 12 months of working in a clean room environment-OR- High School Diploma or equivalent will be considered with a minimum of 24 months of working in a clean room environment Sterile gowning experience preferred Maintains a valid driver's license and has a good driving record.
Expert Level Qualifications Bachelor's degree or higher in Microbiology or related field Minimum of 12 months of sterile gowning experience Minimum of 12 months of environmental monitoring sampling and testing experience CETA or NEBB training / certification preferred All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
#LI-SK1 Travel: This role frequently performs work at client sites, so travel (driving a vehicle) to and from client sites is part of the typical workday.
Company vans are provided for travel to client sites, most of which are in southern New England.
Approximately 10% of assignments are multi-day requiring overnight accommodation.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms.
The employee is required to talk and hear.
The employee is frequently required to stand, walk and sit.
The employee may be occasionally required to climb or balance.
The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration.
The noise level in the work environment is usually quiet.
The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions.
The employee is required to wear the appropriate personal protective equipment to perform the job duties.
Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
Entry Level Qualifications Associate's degree in Microbiology or related field with a minimum of 12 months of working in a clean room environment-OR- High School Diploma or equivalent will be considered with a minimum of 24 months of working in a clean room environment Sterile gowning experience preferred Maintains a valid driver's license and has a good driving record.
Expert Level Qualifications Bachelor's degree or higher in Microbiology or related field Minimum of 12 months of sterile gowning experience Minimum of 12 months of environmental monitoring sampling and testing experience CETA or NEBB training / certification preferred All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
#LI-SK1Expert use of scientific equipment while following policies and procedures Measure total air particulate, temperature, humidity and differential pressure Collect viable air and surface samples Collect purified water samples for testing Incubate media plates and enumerate any microbial growth Submit growth for microbial identification per procedure and client instruction Maintain and prepare equipment in a GMP environment.
Prepare and complete documentation (paper and electronic) per GDP.
Transport equipment and media to client sites within the New England region in company provided vehicles Familiarization with client cleanroom layouts, sampling plans and contamination control programs Sterile gowning and staging equipment and media into client cleanrooms for testing Other duties as assigned You will work with team members and under the direction of Cleanroom Services management to improve performance and client satisfaction.
Experienced Analysts will also - Perform compressed gas testing - Perform HEPA filter testing - Write risk assessments, sampling plans, investigations, protocols, reports, SOPs and other technical documents - Design and build electronic workflows - Peer review data - Assist with training - Cross-train to support other business functions, which may include: Validations, Metrology, Microbiology, Quality Assurance, Sales Support and Leadership
Auto-ApplyScientist, Formulation Development
Alkermes job in Waltham, MA
Join us in this exciting role as Scientist in the Formulation Development group where you'll provide great impact in leading technical innovation while also designing and executing lab experiments for small molecule formulation development.
Deep and thorough understanding of the development of pharmaceutical dosage forms with a focus on how physicochemical properties impact dosage form development and product quality.
Understanding of lab-scale production equipment such as tableting, granulation, blending, milling, spray drying, coating, and drying.
Demonstrated a track record of solving complex technical problems, showcasing leadership in a technical capacity, and ability to expand beyond your area of expertise.
Excellent communication, organization, and planning skills, along with a high level of technical aptitude and creativity.
Proven ability to apply scientific principles to design, execute, and interpret experiments, including statistical design of experiments.
Ability to interact and collaborate within a diverse and interdisciplinary team environment on creative problem-solving.
Degree in chemical engineering, pharmaceutical science, materials science, or related physical science with a PhD and 0-3 years, or an MS with 6+ years, or a BS with 10+ years of experience in pharmaceutical development.
Experience with PAT/Chemometrics and/or Continuous Manufacturing is preferred but not required.
#LI-MB1
Provide technical leadership in designing and executing lab-based experiments to develop small molecule formulations across various stages.
Proficient execution and interpretation of materials testing techniques, drug substance and drug product characterization concepts, and pharmaceutical unit operations to meet clinical deliverables and expand in-house knowledge.
Support strategic planning and meet project deliverables within timelines, incorporating both immediate and long-term goals.
Collaborate effectively within the Pharmaceutical Development group and development teams fostering diversity, inclusion, and belonging.
Maintain and enhance scientific/technical knowledge, champion ideas for new projects,
Auto-ApplyDirector, Regulatory Affairs, Labeling
Alkermes job in Waltham, MA
Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs).
The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity.
This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary.
Auto-ApplyAssociate Chemical Engineer
Waltham, MA job
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview Snapdragon Chemistry is currently seeking exceptional candidates to join the Engineering and Manufacturing team in Waltham, MA.
A successful candidate will be joining a group of innovative and entrepreneurial engineers and scientists, with broad deliverables including the development of reactor systems and purifications for continuous flow processes, delivery of high quality, complex chemical matter to our clients, and transferring process technology to clients at their facility.
The ideal candidate will have a degree in chemical engineering with experience and a passion for developing new process technology.
The candidate should enjoy building equipment and carrying out process development and manufacturing activities in a laboratory or kilo-laboratory environment.
The candidate should be well versed in process development and scale-up activities, including common reaction, separation and purification techniques, such as working with 10-100L batch reactors, liquid-liquid extractions, vacuum distillation, filtration, and crystallization.
Experience with the development of reactions in flow is preferred but not required.
Candidates must possess strong written and oral communication skills.
Responsibilities Leverage scientific and engineering knowledge to deliver high quality, complex chemical matter and data packages to our clients Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders Integrate custom reactor systems following best practices for GMP production.
Support clinical-stage API GMP manufacturing Maintain up-to-date knowledge and follow best practices for process development and regulated pharmaceutical manufacturing.
Qualifications/Skills Required Experience and Skills: Demonstrated ability to take initiative, be creative and innovative, and work productively and efficiently.
Ability to solve complex chemical engineering problems.
Strong written and oral communication skills.
Excellent collaboration skills, team-oriented and invested in the success of others.
Ability and demonstrated willingness to comply with, and encourage amongst others, the ethical and cultural standards of Snapdragon Chemistry.
Preferred Experience and Skills: Demonstrated to work in a kilo lab environment using glass reactor equipment Demonstrated ability to put together and/or follow batch records in a GMP environment Working understanding of ICH and FDA guidelines for GMP manufacture Education, Experience & Licensing Requirements Bachelor's or Master's degree in Chemistry, Chemical Engineering, or a related discipline with 1-3 years of experience.
The estimated salary range of $77,000 - $84,000 reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, and certifications or other professional licenses held.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
Bachelor's or Master's degree in Chemistry, Chemical Engineering, or a related discipline with 1-3 years of experience.
Leverage scientific and engineering knowledge to deliver high quality, complex chemical matter and data packages to our clients Participate in project teams to complete complex deliverables within stringent timelines and communicate results to key stake-holders Integrate custom reactor systems following best practices for GMP production.
Support clinical-stage API GMP manufacturing Maintain up-to-date knowledge and follow best practices for process development and regulated pharmaceutical manufacturing.
Auto-ApplyFormulation Development Co-Op
Alkermes job in Waltham, MA
Alkermes is looking for a motivated student to join our Formulation Development team. You'll work on developing oral solid dose formulations, focusing on how pharmaceutical material flow and compress, key factors in making reliable medicines.
Auto-ApplyTerritory Business Manager (Addiction) - Orange County
Alkermes job in Waltham, MA
Territory Business Manager (TBM) is responsible for maximizing sales of VIVITROL in the Oregon South territory. Ideal candidates will live in Territory and overnight travel is limited. This will be done by having thorough product, disease state and market knowledge and sound selling skills. He/she will utilize available resources to help educate and influence healthcare providers. Finally, he/she will use their analytical ability to assess targets and will use approved resources and efforts accordingly.
Minimum Education & Experience Requirements:
BA/BS
1-2 years of pharma/biotech/med device/B2B sales experience and/or extensive market experience
Must live within the geography of responsibility
Driver's license must be in good standing
Must be able to demonstrate or secure appropriate credentialing, as may be required by healthcare providers for physical access to their facilities
Preferred Skills and Knowledge Requirements:
3+ years successful pharma/biotech sales experience in the Addiction Medicine/Mental Health space
Proven track record of success
Superior organizational and administrative skills
Strong analytical, strategic and influencing skills
Some overnight travel may be required
The annual base salary for this position ranges from $125k to $155k. In addition, this position offers a performance based sales incentive bonus targeted at forty five thousand dollars annually and eligibility to participate in our long term incentive program. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: *************************************
#LI-TT1 #LI-remote
The TBM will demonstrate a strong understanding of all aspects of VIVITROL, alcohol and opioid dependence and related products in the marketplace
The TBM will demonstrate strong selling skills through the use of approved sales aids, approved studies and reprints and through superior communication and listening skills with targeted healthcare providers. He/she will use selling skills that demonstrate competent use of all facets of the Alkermes selling model. He/she will demonstrate an ability to gain agreement for increased product use from target healthcare providers
The TBM will demonstrate strong territory management skills by identifying and calling on appropriate numbers of healthcare provider targets with the required frequency to assure proper usage of Alkermes products. He/she will continually develop, review, update and maintain healthcare provider target lists based on the latest information and data
He/she will utilize all available resources and programs (samples, Speaker Programs, etc.) to increase their business. He/she is prepared to discuss all aspects of territory business with District Business Leader (DBL) at any time
The TBM will develop business plans as required by the DBL and will perform all administrative tasks requested in a timely, accurate and truthful manner
The TBM will exercise fiscal control of operational expenses (car, gas, office supplies, telephone, postage, lodging, meals and entertainment)
The TBM will demonstrate an ability to work productively with individuals in related positions including but not limited to other representatives, DBL, Managed Markets, Marketing, Key Accounts and headquarter personnel
The TBM will abide by all Alkermes policies and regulations regarding promotional compliance, and sample accountability compliance
Auto-ApplyDirector, Health Eco and Outcomes Research
Alkermes job in Waltham, MA
We are seeking a highly motivated and strategic individual for a Director of Health Economics and Outcomes Research (HEOR) role at Alkermes. This is an exciting, visible, and highly collaborative opportunity where you will play a pivotal role in executing on evidence generation plans in support of Alkermes' most advanced pipeline program in sleep-wake disorders. You will report to and support the Head of HEOR in the delivery of research activities and development of materials to support engagements with key stakeholders, including physicians, regulatory agencies, reimbursement bodies, and patients/advocates. The ideal candidate will have a strong technical background in HEOR, excellent data science and visualization skills, great written and verbal communication skills, and a proven ability to foster and manage internal and external relationships effectively.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with at least 60% of time in the office and up to 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
Auto-ApplyPrincipal Scientist, Analytical Development
Alkermes job in Waltham, MA
The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and is a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization.
The Principal Scientist works within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization.
The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.
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